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

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.
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)].
Genzyme Recalls Three Lots of Thymoglobulin
May 8, 2008
On April 9, 2008, Genzyme Corporation (Framingham, MA) announced a recall of three lots of its organ-rejection antibody, Thymoglobulin, because of stability concerns.
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).
DSM Biologics and Upfront to Develop a Fully Disposable Chromatography System Optimized for High Yield Cell Line Production
May 8, 2008
DSM Biologics (Heerlen, the Netherlands), and Upfront Chromatography A/S (Copenhagen, Denmark) have announced a collaboration to optimize Upfront’s new, fully disposable chromatography system for use with DSM's proprietary manufacturing technology.
FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.
FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
FDA Takes Action against Cream Cheese Companies, Executives
Manufacturer Removes Remaining Stocks of Trasylol
FDA Approves New Formulation of Coagulation Therapy
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FDA's Inspection Program Under Scrutiny
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FDA Encourages Quality by Design Initiatives
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Characterization of anti-HCP Antibodies by 2D-HPLC
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Asset Management for Growing Biotech Companies
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Cleaning Validation: On-Site Trials of SpotView(R)
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Fermentation Process Monitoring: Dissolved Carbon Dioxide
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Rapid Characterization of Variable Regions of Monoclonal Antibodies by Top-Down Sequencing using Synapt HDMS
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