Manufacturing remediation, not efficacy or safety data, is delaying US approval of Novo's h+emophilia A therapy denecimig.
|Articles|June 15, 2016
- BioPharm International-06-15-2016
- Volume 2016 ebook
- Issue 1
Biomanufacturers Demand Higher Quality Standards in 2016
Author(s)Eric Langer
Biopharmaceutical manufacturers continue to put quality at the forefront of their relationships.
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Quality considerations have always been vital to biotherapeutic developers and CMOs. Yet, in 2016, it seems that these considerations are taking on a new emphasis. One of the main industry trends seen this year-increased attention to continuous bioprocessing-is at least partly driven by the potential for improved product quality.
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over 10 years ago
Contract Service Providers Gear Up to Develop Emerging Therapiesover 10 years ago
Biopharma Service Providers Address a Full Plate of Challengesover 10 years ago
Dealing with Pharmaceutical Supply-Chain Complexitiesover 10 years ago
Keeping it Simple: Collaborating for Success in Drug Deliveryover 10 years ago
Preventing Phase III Failuresover 10 years ago
Outsourcing Industry Marked by Considerable Investments in 2016Advertisement
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