BioPharm International - Articles on bioprocessing methods, regulatory compliance, and biotech strategies

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Enhancing Tech Transfer
April 29, 2008
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Outsourcing Insights
Biomanufacturing Pendulum Swings Toward Overcapacity

Compliance Notes
Coming to Biotech Near You: Quality by Design Part 1: Its Applicability in Biopharmaceuticals

India Today
India's Clinical Trials Market Accelerates

Final Word
Managing the Global Supply Chain

Eli Lilly and NIBRT Enter Research Collaboration
May 8, 2008
The National Institute for Bioprocessing Research and Training (NIBRT, Dublin, Ireland) has entered into a new research collaboration with US pharmaceutical company Eli Lilly (Indianapolis, IN).
FDA Finalizes CMC Guidance for Gene Therapy INDs
May 8, 2008
The FDA has issued its guidance for chemistry, manufacturing, and control information that is included in investigational new drug applications (INDs) for gene therapies, called “Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs).”
Zelos Therapeutics and Aegis Therapeutics Announce Collaboration for Intranasal Delivery of Zelos’ ZT-031
May 8, 2008
Zelos Therapeutics, Inc. (West Conshohocken, PA) and Aegis Therapeutics LLC (San Diego, CA) have announced a collaboration for the development of an intranasal spray formulation of the proprietary parathyroid hormone (PTH) analog ZT-031 [Ostabolin-C, cyclic PTH-(1-31)].
Leached Impurity Found in Cubicin Stored in Cardinal Health’s ReadyMED Pumps
May 8, 2008
Cubist Pharmaceuticals, Inc. (Lexington, MA) informed healthcare professionals on April 4 that a potentially significant impurity, 2-mercaptobenzothiazole (MBT), has been isolated from reconstituted Cubicin stored in ReadyMED elastomeric infusion pumps manufactured by Cardinal Health, Inc. (Dublin, OH).
Merck Receives Warning Letter for Vaccine Operations
May 8, 2008
The FDA issued a warning letter to Merck and Co. (Whitehouse Station, NJ) on April 28, citing numerous GMP violations at Merck’s vaccine production operations in West Point, PA.
FDA Approves First Generic Ropinirole
FDA Completes Final Analysis of "Total Body Formula" and "Total Body Mega Formula" Products
Manufacturer of Heart Defibrillator Signs Consent Decree of Permanent Injunction
FDA Embarks on Major Hiring Initiative for its Public Health Mission
FDA Approves Amitiza for IBS-C
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An Underfunded FDA Fights Back
Under fire, FDA is taking steps to regain its stature as an effective science-based regulatory agency.
BioPharm International - May 1, 2008
FDA's Inspection Program Under Scrutiny
The heparin safety crisis puts a spotlight on manufacturing processes and regulatory oversight
BioPharm International - April 1, 2008
FDA Encourages Quality by Design Initiatives
BioPharm International - March 1, 2008
Asset Management for Growing Biotech Companies
May 9, 2008
Cleaning Validation: On-Site Trials of SpotView(R)
April 14, 2008
Fermentation Process Monitoring: Dissolved Carbon Dioxide
March 1, 2008
Transforming Technology Transfer and Process Definition Management: From Spreadsheets to Standardized Practices
January 21, 2008
Routine Profiling of Reduced Antibodies by LC/ESI Quadrupole MS
January 21, 2008
Webcasts
May 8 & 21, 2008:
Understanding the Standard Setting Process of the United States Pharmacopeia and National Formulary Part 1 management
Susan Schniepp, Schniepp and Associates

May 14, 2008:
Modern approaches to analytical method development and optimization
Ira Krull Ph.D., Northeastern University

May 20, 2008:
Systems Solutions for Governance and Compliance
Terrence Leach, Manager, Regulatory and Capital Markets Consulting

June 12, 2008:
Quality Systems in a Global Market
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