Articles
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Five Year Trouble Free Manufacturing For Large Pharma Company
9/28/2011
Alkermes, through the merger with Elan Drug Technologies, to become Alkermes plc, has been developing and manufacturing commercial scale solid oral dosage products for over 40 years.
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Bio Data Points
5/19/2011
Nearly all biopharmaceutical developers use outsourcing services of some kind, whether for manufacture of clinical or commercial supplies, assays, process development, or many other activities. By Eric Langer, president and managing partner, BioPlan Associates, Inc.
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White Paper: Bio Data Points
5/19/2011
Nearly all biopharmaceutical developers use outsourcing services of some kind, whether for manufacture of clinical or commercial supplies, assays, process development, or many other activities. By Eric Langer, president and managing partner, BioPlan Associates, Inc.
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Late Phase Research
5/11/2011
The post-marketing environment is evolving rapidly — and without the right strategy, new challenges can squeeze precious value out of your investment.
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Data Driven Market Success
5/11/2011
A Quintiles customer needed an experienced post-marketing ally who could plan for the unknown and design an observational study to eventually include several affiliates, thousands of sites, and more than 55,000 patients, with start-ups staggered over time.
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Brochure: Custom Synthesis
12/6/2010
PharmaZell draws upon a long history of successful custom synthesis projects, performed on a proprietary basis for pharmaceutical companies worldwide.
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White Paper: The Scientific Path To Cycle Development
10/18/2010
Management of medication delivery through lyophilization — freeze-drying — is a crucial enabling process technology for many important parenteral drugs. Close to 50% of biopharmaceuticals, including enzymes, proteins, and monoclonal antibodies, must be lyophilized as these therapeutic agents are insufficiently stable for ready-to-use solution dosage forms. By Baxter Healthcare Corporation -- BioPharma Solutions
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Brochure: Drug Development
8/10/2010
PharmaZell is your partner for custom synthesis and cGMP manufacturing of small molecule APIs and intermediates.
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Brochure: Contract Manufacturing
8/6/2010
Drug Substance and Advanced Intermediate development and manufacture to support clinical through commercial requirements.
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Comprehensive Preclinical Development Program
4/9/2010
Aptuit was asked to conduct an extended package of preclinical studies within a short time frame. As the critical studies are dependent on the results of earlier work in the package (for example, initiation of the 28 day toxicology studies are dependent on the completion of bioanalytical method development, dose range finding, etc.) not only scheduling, but adherence to the schedule was the major risk to achievement of the overall aim, and on time filing to the regulator. By Aptuit, Inc.