March 2017
Volume 12 Issue 3 |
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In the Lab
Mass spectrometry plays an important role in advancing on biologic drug development and manufacturing, but limitations still exist.
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Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
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Metrohm USA presented the Young Chemist Award to Aldin Malkoc for his work on cooperative, DNA-based molecular elements for electrochemical biosensors.
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Sartorius and EMBL have entered into a corporate partnership program to foster advanced training.
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SGS expands its elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France.
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APIs & Excipients
Meeting evolving global requirements for excipients requires close collaboration between pharmaceutical companies and excipient suppliers.
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The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
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Outsourcing Update
Politics, drug prices, tax reform, regulatory uncertainty leave CDMOs/CMOs guessing about pharma's future.
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Supply Chain Update
Monitoring supply-chain risk involves more than running a credit check on potential suppliers. It can, however, be done without external expense.
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Research by Pew Charitable Trust and ISPE suggests that inability to forecast internal demand, and poor partner alignment are among the reasons for drug shortages.
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Contract Services Update
The company opened a new bioconjugation unit to support the clinical and commercial manufacturing of ADCs.
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The acquisition complements Catalent's global OTC and prescription pharmaceutical softgel capabilities and capacity.
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The company announced that no Form 483 was observed at the company's facility in Bangalore, India.
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The company expanded fill/finish services at its facility in Kalamazoo, Michigan.
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Under the agreement, Abzena will manufacture magacizumab, an antibody created using the 'Abzena inside' Composite Human Antibody technology.
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Quotient Clinical's addition of CDMO QS Pharma increases the company's footprint in the US an adds high potency molecule capability.
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Recipharm's addition of Kemwell's Bengaluru, India facility expands its solid- and liquid-dosage capabilities.
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