http://biopharminternational.findpharma.com/biopharm/Quality/Article/list/40467 Essential information about quality assurance and quality control, including analytical methods, analytical method development, statistical methods, and process analytical technology (PAT). 2009-11-21T13:13:12Z http://biopharminternational.findpharma.com/biopharm/Quality/Quality-by-Design-for-Biotechnology-ProductsmdashP/ArticleStandard/Article/detail/640113?contextCategoryId=40467&ref=25 A PhRMA Working Group's advice on applying QbD to biotech 2009-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452009/640113null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/FDA-Leaders-Stress-Science-and-Compliance/ArticleStandard/Article/detail/632931?contextCategoryId=40467&ref=25 Stiffer enforcement of quality standards aims to restore public confidence in agency actions. 2009-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412009/632931null XML http://biopharminternational.findpharma.com/biopharm/Trends/Cleanrooms-amp-Facilities/ArticleStandard/Article/detail/625166?contextCategoryId=40467&ref=25 To assess current trends in cleanrooms and engineering & facilities, BioPharm International turned to Parrish Galliher, founder and chief technology officer, Xcellerex, Inc.; Jim Maslowski, owner, PDC Aseptic Filling Systems; Morgan Polen, vice president, application technology, Lighthouse Worldwide Solutions; and Benoît Verjans, commercial director, Aseptic Technologies. 2009-09-09T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/625166null HTML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Biopharmaceutical-Manufacturers-Seize-Opportunitie/ArticleStandard/Article/detail/624454?contextCategoryId=40467&ref=25 The FDA is encouraging manufacturers to invest in research and development for new vaccines and therapeutics to combat third-world diseases. 2009-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372009/624454null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Health-Reform-Challenges-Biotech-Industry/ArticleStandard/Article/detail/615150?contextCategoryId=40467&ref=25 Pressures to reduce healthcare spending generates proposals to spur competition, cut costs. 2009-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312009/615150null XML http://biopharminternational.findpharma.com/biopharm/Quality/Use-of-Change-Point-Analysis-for-Process-Monitorin/ArticleStandard/Article/detail/615153?contextCategoryId=40467&ref=25 A better method for trend analysis than CUSUM and control charts. 2009-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312009/615153/bp0809_Gavit_LabPic1_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Quality/Analytical-Tools-for-Process-and-Product-Character/ArticleStandard/Article/detail/615148?contextCategoryId=40467&ref=25 Select the best approach to determine critical quality attributes. 2009-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312009/615148/bp0809_analytical_tools_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Extended-Risk-Management-Proposals-Challenge-Manuf/ArticleStandard/Article/detail/608686?contextCategoryId=40467&ref=25 The FDA seeks new strategies for improving the safe use of opioids and other high-risk medicines, including erythropoiesis stimulating agents. 2009-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272009/608686null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Stiffer-Enforcement-at-the-FDA/ArticleStandard/Article/detail/601412?contextCategoryId=40467&ref=25 Agency officials promise swift action against violators of drug safety and quality regulations. 2009-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232009/601412null XML http://biopharminternational.findpharma.com/biopharm/Quality/QbD-Convincing-the-Skeptics/ArticleStandard/Article/detail/596027?contextCategoryId=40467&ref=25 Without a rigorous discussion of the pros and cons of QbD, its tremendous benefits will be lost. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596027null XML http://biopharminternational.findpharma.com/biopharm/Quality/Monitoring-of-Biopharmaceutical-Processes-Present-/ArticleStandard/Article/detail/596026?contextCategoryId=40467&ref=25 This article reviews some of the commonly used approaches for process monitoring as well as the evolution of process monitoring in the Quality by Design (QbD) paradigm. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596026null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Comparative-Effectiveness-Research-to-Shape-Biotec/ArticleStandard/Article/detail/596022?contextCategoryId=40467&ref=25 Authorities are pushing for CE; manufacturers prefer to focus on value. 2009-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182009/596022null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Food-and-Drug-Safety-Crises-Prompt-White-House-Con/ArticleStandard/Article/detail/590345?contextCategoryId=40467&ref=25 The FDA is poised to gain more authority and resources to ensure product quality. 2009-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142009/590345null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Biotech-Therapies-Face-Disclosure-Requirements/ArticleStandard/Article/detail/585549?contextCategoryId=40467&ref=25 Broader transparency in product prices and payments to researchers aim to curb conflicts of interest and rationalize drug expenditures. 2009-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/102009/585549null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Biotech-Drug-Prices-Under-Scrutiny/ArticleStandard/Article/detail/580773?contextCategoryId=40467&ref=25 With cuts in healthcare, biotech drugs are under scrutiny. 2009-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072009/580773null XML http://biopharminternational.findpharma.com/biopharm/Quality/QbD-for-Analytical-Methods/ArticleStandard/Article/detail/580778?contextCategoryId=40467&ref=25 QbD for QA? Try a two-step approach 2009-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072009/580778null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/QbD-Industrial-Case-Studies-on-Defining-and-Implem/ArticleStandard/Article/detail/575066?contextCategoryId=40467&ref=25 Understanding the relationship between the process and CQAs. 2009-01-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032009/575066/Quality_by_Design_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Revitalization-Reform-Ahead-for-The-FDA/ArticleStandard/Article/detail/575064?contextCategoryId=40467&ref=25 FDA aims to regain public confidence in 2009. 2009-01-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/032009/575064null XML http://biopharminternational.findpharma.com/biopharm/Quality/The-New-Era-of-Process-Validation/ArticleStandard/Article/detail/568927?contextCategoryId=40467&ref=25 The FDA's revised process validation guidance manages to explain the underlying concepts of Quality by Design without every using the phrase. 2008-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492008/568927null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/QbD-Industrial-Case-Studies-on-Defining-and-Implem/ArticleStandard/Article/detail/568934?contextCategoryId=40467&ref=25 Using multivariate experiments to define acceptable ranges. 2008-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492008/568934/Quality_by_Design_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/How-to-Make-the-Business-Case-for-Quality-by-Desig/ArticleStandard/Article/detail/568935?contextCategoryId=40467&ref=25 No time for QbD? How to convince management to make it a priority. 2008-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492008/568935/Rationale_for_QbD_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Big-Changes-Ahead-for-Biotech-Manufacturers/ArticleStandard/Article/detail/568928?contextCategoryId=40467&ref=25 To expand coverage amidst the economic crisis, Obama will be looking hard for ways to cut healthcare costs. 2008-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492008/568928null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Regulation-of-Biomarker-Clinical-Laboratory-Tests-/ArticleStandard/Article/detail/568932?contextCategoryId=40467&ref=25 A clear oversight framework for biomarker clinical laboratory tests used in personalized medicine is required. 2008-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492008/568932null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Nanotechnology-Creates-Opportunities-Challenges-fo/ArticleStandard/Article/detail/566017?contextCategoryId=40467&ref=25 The FDA and other regulatory authorities are evaluating new regulations to ensure the safety and quality of nanomaterials in biomedical products. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566017null XML http://biopharminternational.findpharma.com/biopharm/Quality/Aggregates-in-MAbs-and-Recombinant-Therapeutic-Pro/ArticleStandard/Article/detail/566023?contextCategoryId=40467&ref=25 FDA perspectives on specs and effective control strategies. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566023/BP1108_MAb_aggregates_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Quality/Statistical-EssentialsmdashPart-4-Regression-and-D/ArticleStandard/Article/detail/566021?contextCategoryId=40467&ref=25 Well-designed experiments can reduce the risk of coming to an incorrect conclusion during a process characterization, assay validation, or process validation study. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566021null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Compliance+Articles/Global-QA-and-Regulatory-Compliance-The-Business-C/ArticleStandard/Article/detail/566025?contextCategoryId=40467&ref=25 A centralized quality control strategy may be the best solution. 2008-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/462008/566025/200494108-001_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Quality/FDA-Promotes-QbD-for-Biotech-Therapies/ArticleStandard/Article/detail/557244?contextCategoryId=40467&ref=25 The FDA's QbD pilot program is supporting good manufacturing on a global basis. 2008-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412008/557244null XML http://biopharminternational.findpharma.com/biopharm/Quality/Minimizing-the-Problem-of-OOS/ArticleStandard/Article/detail/545363?contextCategoryId=40467&ref=25 Statistical methods for calculating confidence intervals, tolerance intervals, and capability analysis to reduce out-of-specification situations. 2008-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/352008/545363null XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/FDA-Launches-E-Filing-Initiative/ArticleStandard/Article/detail/529021?contextCategoryId=40467&ref=25 The FDA is launching a pilot program to allow manufacturers to electronically file drug establishment registration and drug listing information, such as ingredients, labeling, and manufacturing information. 2008-07-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/282008/529021null HTML http://biopharminternational.findpharma.com/biopharm/Compliance+Notes/Coming-to-a-Biotech-Near-You-Quality-by-Design-Par/ArticleStandard/Article/detail/527446?contextCategoryId=40467&ref=25 Quality by Design and Design Space can be used by companies to enhance process understanding, improve scientific rigor, and enhanced qualitative and quantative performance, as well as cost savings. 2008-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272008/527446null XML http://biopharminternational.findpharma.com/biopharm/Statistics+Essentials/The-Power-of-Hypothesis/ArticleStandard/Article/detail/522180?contextCategoryId=40467&ref=25 How to use hypothesis correctly, and understanding the difference between one-sample, two-sample, and z-test. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522180null XML http://biopharminternational.findpharma.com/biopharm/Quality/Avoiding-the-Pain-of-Out-of-Specification-Results/ArticleStandard/Article/detail/522197?contextCategoryId=40467&ref=25 Improving your quality operations by using sound statistical principles. 2008-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/232008/522197/OOS_results_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Compliance+Notes/Coming-to-Biotech-Near-You-Quality-by-Design-Part-/ArticleStandard/Article/detail/513383?contextCategoryId=40467&ref=25 The principles of QbD can be applied to biotech development and manufacturing to help resolve many common issues. QbD scientifically provides a greater understanding of the complex relationships among product quality attributes, the manufacturing process, and clinical safety and efficacy by determining the various permutations of critical input variables that will keep the product within specification. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182008/513383null XML http://biopharminternational.findpharma.com/biopharm/Quality/Cumulative-Sum-Charts-for-Problem-Solving/ArticleStandard/Article/detail/514502?contextCategoryId=40467&ref=25 CUSUM charts are easy to create in Excel and can reveal when a change occurred. 2008-05-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/192008/514502/0508_CUSUM_Bandurek_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Devising-an-International-Clinical-Trial-Distribut/ArticleStandard/Article/detail/509925?contextCategoryId=40467&ref=25 A decision-criteria matrix and cost models helped pinpoint the best distribution approach for the short- and long-term. 2008-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/162008/509925null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/How-to-Conduct-an-Audit-of-an-Outsourcing-Provider/ArticleStandard/Article/detail/507456?contextCategoryId=40467&ref=25 There are several considerations to keep in mind when auditing an outsourcing provider. 2008-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507456null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Outsourcing-Laboratory-WorkmdashEstablishing-the-N/ArticleStandard/Article/detail/507455?contextCategoryId=40467&ref=25 The outsourced service provider should be considered an extension of your own laboratory. 2008-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507455null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Working-with-a-Contract-Manufacturer-Key-Considera/ArticleStandard/Article/detail/507452?contextCategoryId=40467&ref=25 After a strategic evaluation of what activities to outsource, sponsor companies should follow key guidelines for selecting and auditing a provider and preparing quality agreements. 2008-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507452null XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Biopharmaceutical-Contract-Manufacturing-Contracto/ArticleStandard/Article/detail/507454?contextCategoryId=40467&ref=25 When a biopharmaceutical company pursues an outsourcing strategy, the choice of a contractor is a critical and strategic decision. 2008-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142008/507454null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Evaluation-of-Dendritic-Cell-Products-Generated-fo/ArticleStandard/Article/detail/499137?contextCategoryId=40467&ref=25 Emerging therapies pose challenges for standardizing QC. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499137/Whiteside_Dendritic_Cell_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Compliance+Notes/How-to-Ensure-Smooth-Technology-Transfer/ArticleStandard/Article/detail/499135?contextCategoryId=40467&ref=25 A comprehensive process and analytical transfer package can speed up your product's time to market and save costs. 2008-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/092008/499135null XML http://biopharminternational.findpharma.com/biopharm/Quality/Strategies-for-Validation-Extensions/ArticleStandard/Article/detail/490816?contextCategoryId=40467&ref=25 It is essential to understand the critical elements of validation extensions to ensure accurate process or product quality measurements. 2008-02-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072008/490816null XML http://biopharminternational.findpharma.com/biopharm/Quality/Analytical-Method-Maintenance/ArticleStandard/Article/detail/490817?contextCategoryId=40467&ref=25 Several steps can be taken to maintain test method suitability after the formal completion of the analytical method validation studies, 2008-02-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072008/490817null XML http://biopharminternational.findpharma.com/biopharm/Quality/Formal-Method-Validation/ArticleStandard/Article/detail/490815?contextCategoryId=40467&ref=25 The development and optimization process can improve a method, but validation does not. Validation is the final proof that regulations and expectations are met. 2008-02-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072008/490815null XML http://biopharminternational.findpharma.com/biopharm/Quality/Analytical-Method-Development-and-Optimization/ArticleStandard/Article/detail/490814?contextCategoryId=40467&ref=25 Validation of analytical methods can be more easily accomplished by breaking the task down into a series of planned steps. 2008-02-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072008/490814null XML http://biopharminternational.findpharma.com/biopharm/Final+Word/The-Role-of-Analytical-Science-in-the-Debate-over-/ArticleStandard/Article/detail/490802?contextCategoryId=40467&ref=25 Both innovator and generics companies are using analytics to support comparability arguments. 2008-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072008/490802null XML http://biopharminternational.findpharma.com/biopharm/Disposables/Extractables-and-Leachables-Study-Approach-for-Dis/ArticleStandard/Article/detail/490803?contextCategoryId=40467&ref=25 Two case studies illustrate a systematic approach. 2008-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072008/490803/ding_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Statistics+Essentials/Presenting-Data-Effectively/ArticleStandard/Article/detail/490804?contextCategoryId=40467&ref=25 The key to a good graphical presentation is to select the method that best fits the data. 2008-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/072008/490804null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Elements-of-QbD-in-Development-and-Scale-Up-of-Fre/ArticleStandard/Article/detail/481928?contextCategoryId=40467&ref=25 Design space concepts are key to a successful technology transfer. 2008-01-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/012008/481928/elements_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/012008/481928/Nail_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Outsourcing/Quality-by-Design-in-the-CMO-Environment/ArticleStandard/Article/detail/478714?contextCategoryId=40467&ref=25 How the authors used design of experiments and quality by design principles to develop a hydrophobic interaction chromatography step. 2007-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/502007/478714/qualitybydesign_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/502007/478714/Original[1]lr_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/A-History-of-the-OOS-Problem/ArticleStandard/Article/detail/470169?contextCategoryId=40467&ref=25 Contrary to popular belief, the out-of-specification problem started years before the Barr Decision. 2007-11-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452007/470169/ahistoryofOOS_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/452007/470169/C0R5371a30_rev_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/News/Quality-by-Design-Pilot-for-Biotechs-Will-Focus-on/ArticleStandard/Article/detail/464085?contextCategoryId=40467&ref=25 The upcoming Quality by Design (QbD) pilot program for biotech filings will focus on comparability protocols, Helen Winkle, director of the Office of Pharmaceutical Science at the FDA's Center for Drug Evaluation and Research, said on September 20, 2007. 2007-10-10T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412007/464085null HTML http://biopharminternational.findpharma.com/biopharm/GMPs%2FValidation/Protein-Therapeutics-and-the-Regulation-of-Quality/ArticleStandard/Article/detail/462759?contextCategoryId=40467&ref=25 Regulatory agencies have evolved along with the biotechnology industry to define quality standards. 2007-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462759/Page37_BP_t_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462759/Kozlowski_flash.gif XML http://biopharminternational.findpharma.com/biopharm/Business/On-the-Biotechnology-Frontier-Personalized-Medicin/ArticleStandard/Article/detail/462868?contextCategoryId=40467&ref=25 Favrille, a San Diego-based biopharmaceutical company, is one of a handful of firms on the forefront of personalized medicine. Because personalized treatment is tailored to an individual's biology, it has the potential to be far more effective than current approaches to disease management. 2007-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462868/Page154_BP_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462868null XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Applications-of-MVDA-in-Biotech-Processing/ArticleStandard/Article/detail/462928?contextCategoryId=40467&ref=25 Multivariate data analysis can help biotech manufacturers deepen their process understanding. 2007-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462928/Page130_BP_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/402007/462928/COC079LHa_rev_flash.gif XML http://biopharminternational.findpharma.com/biopharm/Downstream+Processing/Lifetime-Studies-for-Membrane-Reuse-Principles-and/ArticleStandard/Article/detail/451555?contextCategoryId=40467&ref=25 2007-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342007/451555/downstream_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342007/451555/rathore_140_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Quality/Evaluation-of-an-Instantaneous-Microbial-Detection/ArticleStandard/Article/detail/451507?contextCategoryId=40467&ref=25 2007-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342007/451507/enviromentalmonitoring_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342007/451507/varnau_140_flash.jpg XML http://biopharminternational.findpharma.com/biopharm/Upstream++Processing+Articles/Vaccine-Characterization-Using-Advanced-Technology/ArticleStandard/Article/detail/444988?contextCategoryId=40467&ref=25 With the advent of high-resolution mass spectrometers and highly sensitive MS instruments, vaccine characterization has entered a new phase. 2007-08-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312007/444988null XML http://biopharminternational.findpharma.com/biopharm/Article/Process-Development-Think-Like-a-ScientistmdashBeh/ArticleStandard/Article/detail/444982?contextCategoryId=40467&ref=25 Understanding the end-to-end management of chemistry, manufacturing, and controls (CMC) resources provides the opportunity to enhance long-term planning, leverage development options, manage resource trade offs, and track progress against plans. The goal is to improve the pharmaceutical development process to deliver the pipeline. This article provides an overview of the organizational structure of Process Research and Development (PR&D) and the CMC teams at Genentech; the alignment of resources based on CMC contracts, process development activity maps and project resource plans; and the business economic analysis for evaluating development options. 2007-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/312007/444982null XML http://biopharminternational.findpharma.com/biopharm/Regulatory+Policy+%26+Regulations+Articles/Draft-ICH-Q10-Guideline-Published-for-Public-Comme/ArticleStandard/Article/detail/443623?contextCategoryId=40467&ref=25 The US FDA (Rockville, MD, www.fda.gov) recently announced the availability of a draft guidance, entitled, Q10 Pharmaceutical Quality System. 2007-07-24T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/302007/443623null HTML http://biopharminternational.findpharma.com/biopharm/Quality/Quantitative-Aspects-of-UPLC-Peptide-Mapping/ArticleStandard/Article/detail/443899?contextCategoryId=40467&ref=25 Throughout the development of a biopharmaceutical protein, peptide mapping is used to demonstrate genetic stability and to confirm the intergrity of the protein. This whitepaper focuses on the quantitative aspects of UPLC peptide mapping with UV detection. 2007-07-23T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/302007/443899null PDF http://biopharminternational.findpharma.com/biopharm/Article/Upstream-Processing-Regulatory-Considerations-Rega/ArticleStandard/Article/detail/439560?contextCategoryId=40467&ref=25 2007-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272007/439560/upstream_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272007/439560null XML http://biopharminternational.findpharma.com/biopharm/Article/From-the-Editor-Learning-from-the-Diethylene-Glyco/ArticleStandard/Article/detail/439418?contextCategoryId=40467&ref=25 Quality guidelines are only as good as their implementation. 2007-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/272007/439418null XML http://biopharminternational.findpharma.com/biopharm/Article/Analytical-Testing-to-Support-Biopharmaceutical-Pr/ArticleStandard/Article/detail/416132?contextCategoryId=40467&ref=25 A tremendous amount of analytical testing is required to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Numerous methods are used to fully characterize large molecules because of their complexity—characterizing them is significantly more difficult than it is for small molecules. Biopharmaceuticals are produced via living systems, i.e., E. coli, yeast, or mammalian cells, which require additional testing matrices. 2007-04-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142007/416132null XML http://biopharminternational.findpharma.com/biopharm/Article/Quality-Design-Space-for-Biotech-Products/ArticleStandard/Article/detail/415832?contextCategoryId=40467&ref=25 Process monitoring ensures that the process performs within the defined acceptable variability that served as the basis for the filed design space. 2007-04-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142007/415832/quality_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/142007/415832null XML http://biopharminternational.findpharma.com/biopharm/News/CMC-Strategy-Forum-Takes-on-Glycosylation/ArticleStandard/Article/detail/413459?contextCategoryId=40467&ref=25 The biopharmaceutical industry has gained a lot of experience in monitoring glycosylation, but still has a lot to learn about the structure–function relationship. 2007-03-22T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/122007/413459null HTML http://biopharminternational.findpharma.com/biopharm/Quality+Articles/USP-Seeks-Participants-for-Glycan-Analysis-Study/ArticleStandard/Article/detail/413458?contextCategoryId=40467&ref=25 The United States Pharmacopeia (USP, Rockville, MD, www.usp.org) and the UK's National Institute for Biological Standards and Control (NIBSC, Hertfordshire, UK, www.nibsc.ac.uk) are seeking participants in a study of analytical methods used by the industry to characterize and quantify oligosaccharides. 2007-03-22T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/122007/413458null HTML http://biopharminternational.findpharma.com/biopharm/Article/Regulatory-Beat-Quality-Standards-to-Reshape-Manuf/ArticleStandard/Article/detail/400863?contextCategoryId=40467&ref=25 A series of ICH guidances are encouraging industry to adopt quality-based approaches for achieving the "desired state" of drug and biotech manufacturing: more efficient and flexible operations that can reliably produce high quality therapies with less regulatory oversight. 2007-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/052007/400863null XML http://biopharminternational.findpharma.com/biopharm/Article/Analytical-Methods-A-Statistical-Perspective-on-th/ArticleStandard/Article/detail/392483?contextCategoryId=40467&ref=25 Vagueness in the ICH Q2A and Q2B guidelines necessitates effective protocol design and data analysis. For specificity (detection in the presence of interfering substances), the goal is statistical differences with meaningful implications on assay performance. Linearity (results directly proportional to concentration of analyte in the sample) is typically demonstrated via least squares regression. Accuracy (difference between measured and true values) usually is presented as a percent of nominal. Precision analysis is vital because it supports claims of accuracy and linearity. A well-designed experiment and statistically relevant methods will facilitate method validation in accordance with ICH guidelines. 2006-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/502006/392483/TN_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/502006/392483null XML http://biopharminternational.findpharma.com/biopharm/Article/Quality-Control-Operator-Error-Is-It-Really-the-Ro/ArticleStandard/Article/detail/392484?contextCategoryId=40467&ref=25 Conducting an analysis of the 4 Ms—man, machine, methods, and materials—enables companies to identify the true root causes of deviations. 2006-12-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/502006/392484/TN_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/502006/392484null XML http://biopharminternational.findpharma.com/biopharm/Quality/Disposables-in-the-Quality-Control-Laboratory/ArticleStandard/Article/detail/423543?contextCategoryId=40467&ref=25 The deliberate reuse of disposables has caused many clinically significant problems. 2006-11-02T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/182007/423543null XML http://biopharminternational.findpharma.com/biopharm/Article/From-the-Editor-We-All-Need-Quality-Systems-Even-a/ArticleStandard/Article/detail/390951?contextCategoryId=40467&ref=25 Whether it's for manufacturing drugs, characterizing cell substrates, or regulating new technology, quality systems provide a needed framework. 2006-11-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492006/390951null XML http://biopharminternational.findpharma.com/biopharm/Article/Specification-Setting-Setting-Acceptance-Criteria-/ArticleStandard/Article/detail/390955?contextCategoryId=40467&ref=25 This article shows how Probabilistic Tolerance Intervals of the form, "We are 99% confident that 99% of the measurements will fall within the calculated tolerance limits" can be used to set acceptance limits using production data that are approximately Normally distributed. If the production measurements are concentrations of residual compounds that are present in very low concentrations, it may be appropriate to set acceptance limits by fitting a Poisson or an Exponential Distribution. 2006-11-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492006/390955/TN_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/492006/390955null XML http://biopharminternational.findpharma.com/biopharm/Article/A-Guide-for-Testing-Biopharmaceuticals-Part-2-Acce/ArticleStandard/Article/detail/377862?contextCategoryId=40467&ref=25 The first part of this article, published in the September 2006 issue, discussed general strategies for validation extensions to other test method components, laboratories and even different test methods.1This second part provides practical tips on how to maintain test method suitability long after the formal completion of analytical method validation (AMV) studies. 2006-10-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412006/377862/TN_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/412006/377862null XML http://biopharminternational.findpharma.com/biopharm/Article/The-Laboratory-Control-System-Fulfilling-cGMP-Requ/ArticleStandard/Article/detail/371020?contextCategoryId=40467&ref=25 Reserve samples of test and control articles must be retained for at least one stability time point after the completion of the study. 2006-09-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372006/371020/TN_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372006/371020null XML http://biopharminternational.findpharma.com/biopharm/Article/A-Guide-for-Testing-Biopharmaceuticals-Part-1-Gene/ArticleStandard/Article/detail/371601?contextCategoryId=40467&ref=25 Good risk management tools dictate how much assay performance characteristics can deviate from ideal. 2006-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372006/371601/TN_thumbnail.jpg http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372006/371601null XML http://biopharminternational.findpharma.com/biopharm/Article/The-Confusion-Around-COTS/ArticleStandard/Article/detail/371604?contextCategoryId=40467&ref=25 Increasingly, pharmaceutical companies have recognized that software development is not their core competency. 2006-09-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/372006/371604null XML http://biopharminternational.findpharma.com/biopharm/Article/Peak-Shape-Calibration-Method-Improves-the-Mass-Ac/ArticleStandard/Article/detail/353130?contextCategoryId=40467&ref=25 A novel calibration approach was developed that not only calibrates the X-axis, but also calibrates the peak shape. 2006-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262006/353130null XML http://biopharminternational.findpharma.com/biopharm/Article/Final-Word-Using-Molecular-Tools-for-Biopharmaceut/ArticleStandard/Article/detail/353134?contextCategoryId=40467&ref=25 For decades now, it has been said that "the process is the product" for biologics. Great care and consistency must be applied in their upstream manufacture—during fermentation, harvest, and early purification—to preserve their complex structure, which confers their activity and specificity. As the product moves to late-stage purification, however, the relative concentration of impurities and altered product forms is diminished. Also, the final dosage form of most large molecule biopharmaceuticals is the relatively simple liquid formulation of parenteral dosage form. In contrast, manufacturing the solid dosage forms common for small-molecule drugs involves more complex processes, such as mixing dry powders, granulation, manufacturing controlled-release matrices, and tableting. 2006-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262006/353134null XML http://biopharminternational.findpharma.com/biopharm/News/Linking-Manufacturing-Specifications-to-Clinical-R/ArticleStandard/Article/detail/340410?contextCategoryId=40467&ref=25 "Clinical data is the gold standard" for setting manufacturing specifications, said Patrick Swann, PhD, acting deputy director of the Division of Monoclonal Antibodies at FDA, at a session on specification setting at the AAPS National Biotechnology Conference that was held June 19-21 in Boston. 2006-06-27T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262006/340410null HTML http://biopharminternational.findpharma.com/biopharm/News/Deciphering-Causes-of-Protein-Aggregation-Requires/ArticleStandard/Article/detail/340403?contextCategoryId=40467&ref=25 Protein aggregation is a term that can include many types of aggregation, from rapidly reversible aggregation caused by non-covalent bonds to irreversible aggregation in the form of covalent oligomers. 2006-06-27T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/262006/340403null HTML http://biopharminternational.findpharma.com/biopharm/Article/Downstream-Process-Optimization-Opportunities-Usin/ArticleStandard/Article/detail/329353?contextCategoryId=40467&ref=25 The purpose of the PAT initiative is to move analytical laboratory functions close to the manufacturing process to improve manufacturing efficiency and product quality. 2006-06-02T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/212006/329353/Tn_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Article/From-the-Editor-in-Chief-When-Does-Glycosylation-M/ArticleStandard/Article/detail/329354?contextCategoryId=40467&ref=25 The belief that glycosylation is critical to ensuring the functionality of protein therapeutics—and preventing immunogenicity—drives many manufacturing decisions. But is it time to question this industry tenet? 2006-06-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Article/Pursuing-Pharmaceutical-Quality-and-Economy/ArticleStandard/Article/detail/329360?contextCategoryId=40467&ref=25 Motorola recognized that vartion is the death knell of any process, so the company established a methodology called Six Sigma 2006-06-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/212006/329360/Tn_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Article/Automated-Process-Control-for-the-Development-Labo/ArticleStandard/Article/detail/312954?contextCategoryId=40467&ref=25 Minimum disruption and maximum gain result when adopting a distributed process control and data management system for a cell culture and fermentation lab. 2006-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112006/312954/TN_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Article/A-Signal-to-Noise-Ratio-is-No-Subsitute-for-a-Brai/ArticleStandard/Article/detail/312953?contextCategoryId=40467&ref=25 Signal-to-noise ratios are useful in robust engineering to design products and processes that consistently deliver on target. 2006-03-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/112006/312953/TN_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Article/Near-Infrared-Analysis-of-Critical-Parameters-in-L/ArticleStandard/Article/detail/304819?contextCategoryId=40467&ref=25 Lyophilized, or freeze-dried, materials are challenging samples for quality assurance and quality control (QA/QC) measurement because of the inability to open the container without corrupting the product. Near-infrared analysis presents itself as the QC method of choice for lyophilized materials due to its ability to penetrate glass or plastic containers to analyze the sample in a non-destructive manner. This study demonstrates the performance of a Fourier transform near-infrared (FT-NIR) spectrometer used in analyzing lyophilized samples of thrombin, a topical coagulant commonly used in the medical and dental fields. Key stability parameters for lyophilized thrombin include moisture and potency, which can be predicted simultaneously from a single spectrum using multivariate analysis. 2006-02-01T05:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/062006/304819/TN_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Article/Final-Word-Statisticians-Tackle-More-Than-Clinical/ArticleStandard/Article/detail/304822?contextCategoryId=40467&ref=25 Statisticians partner with technical experts to design statistically valid studies to construct the appropriate analysis. 2006-02-01T05:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Business/Operations-Excellence-Process-Analytical-Technolog/ArticleStandard/Article/detail/162432?contextCategoryId=40467&ref=25 Three meetings of the BioPharma Operations Excellence Consortium, facilitated by Tefen Operations Management Consulting, were held recently. The east coast meeting was hosted by Genzyme at its headquarters in Cambridge, MA; the west coast Chapter met at the Genentech campus in South San Francisco, CA; and the European forum held its meeting in Frankfurt, hosted by Aventis. 2005-05-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/21+CFR+Part+11/Quality-Agreements-Between-PharmaceuticalBiopharma/ArticleStandard/Article/detail/157266?contextCategoryId=40467&ref=25 During the past several years in the pharmaceutical and biopharmaceutical industries, conflicts and misunderstandings have arisen between companies and their contractors. Too often, productive working relationships have crumbled, resulting in expensive production delays with companies and contractors squabbling over their roles and responsibilities. Such conflicts may have their roots in the lack of a sound quality agreement (QAG). QAGs that clearly delineate good manufacturing practice (GMP) responsibilities between a sponsor and a contractor can help companies and their contractors avoid certain conflicts. 2005-04-01T05:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Quality/Optimization-scale-up-and-validation-ISSUES-in-FIL/ArticleStandard/Article/detail/124669?contextCategoryId=40467&ref=25 Filtration is one of the most commonly used unit operations in the manufacturing of biopharmaceuticals. This is the second part of the fourth article in the "Elements of Biopharmaceutical Production" series. In this second segment, Manoj Menon and Frank Riske present an approach for the development and optimization of a TFF application, followed by a contribution from Jennifer Campbell and Elizabeth Goodrich reviewing key issues involved in validation of a TFF step. 2004-09-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/BMS-or-PLC-Controlling-the-Regulated-Environment/ArticleStandard/Article/detail/124668?contextCategoryId=40467&ref=25 If the system is not 
 21 CFR Part 11-capable or the network 
 configuration is not appropriate, 
 cost is immaterial. 2004-09-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/21+CFR+Part+11/Optimization-scale-up-and-validation-issues-in-Fil/ArticleStandard/Article/detail/115119?contextCategoryId=40467&ref=25 Filtration is one of the most commonly used unit operations in biopharmaceutical manufacturing. Available formats include direct or normal flow filtration (NFF) and cross or tangential flow filtration (TFF). These methods are used for sterilization and virus filtration, depth filtration or ultrafiltration, and diafiltration applications. Some common objectives include: 2004-08-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Quality/Producing-Affordable-High-Purity-Water/ArticleStandard/Article/detail/114986?contextCategoryId=40467&ref=25 A water distribution plan is 
 at the heart of an overall energy and water conservation program. 2004-08-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/342004/114986/mn_tn_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Quality/Applications-A-Total-Water-Purification-System/ArticleStandard/Article/detail/114976?contextCategoryId=40467&ref=25 Although sounding like a singular term, a water purification system actually consists of several key components. 2004-08-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/21+CFR+Part+11/Biosafety-Considerations-for-Cell-Based-Therapies/ArticleStandard/Article/detail/104336?contextCategoryId=40467&ref=25 Is it safe? Answering that question for therapies based on living cells is not simple. 2004-07-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Quality/Operations-Excellence-BioPharma-Consortium-Meets-i/ArticleStandard/Article/detail/104324?contextCategoryId=40467&ref=25 Although there are many differences between the industries, especially related to regulatory requirements, there are enough similarities that the future of biopharmaceuticals with respect to contract manufacturing might look much like the semiconductor industry. 2004-07-01T04:00:00Z XML http://biopharminternational.findpharma.com/biopharm/Manufacturing+Economics+Articles/BSE-Offers-Lessons-in-Risk-Assessment/ArticleStandard/Article/detail/104325?contextCategoryId=40467&ref=25 The approaches taken to containing the risk of BSE reveal patterns in the difficulties of performing and reacting appropriately to risk analysis. 2004-07-01T04:00:00Z http://biopharminternational.findpharma.com/biopharm/data/articlestandard/biopharm/292004/104325/mn_tn_thumbnail.jpg XML http://biopharminternational.findpharma.com/biopharm/Analytical+Methods+Articles/Correlating-the-Results-from-Chemistry-Analyzers/ArticleStandard/Article/detail/102289?contextCategoryId=40467&ref=25 Regression analysis determines the offsets between different methods and instruments that analyze cell media. 2004-06-01T04:00:00Z XML