Search results for " 2016"
Article
Managing Risk in Raw Material Sourcing
…able manufacturing, explained Chris Moreton, consultant with FinnBrit Consulting, during a September 2016 webcast (1).
But there are many factors at play that seem random and cannot be easily pre…
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Advancing Single-Use Technology Through Collaboration
2, 2016.
4. W. Ding, et al., Pharm. Engineering. 34 (6) (2014).
5. S. O’Connor (Regeneron), “BPOG’s Extractable protocol: Proof of concept study data,” Sept. 15, 2015, biophorum.com/images/res…
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Efforts Accelerate to Streamline Postapproval Change Process
She and others described efforts to streamline this cumbersome and costly postapproval change process at the July 2016 CMC Strategy Forum on “Change Happens” organized by CASSS.
Gaining regulatory…
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Biopharma in 2015: A Year for Approvals and Innovations
4, 2016,Bernard Munos, http://www.forbes.com/sites/bernardmunos/2016/01/04/2015-new-drug-approvals-hit-66-year-high/#2715e4857a0b64a57ea71044, accessed Jan. 14, 2016.
2. First Hospira Biosimilar mA…
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Emerging Therapies Test Existing Bioanalytical Methods
The 2016 draft FDA immunogenicity guidance (5) provides the necessary assay parameters to be evaluated, including cut point determination, intra- and inter-assay precision, sensitivity, drug tolerance…
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Transformative Medicines Challenge FDA and Manufacturers
FDA set the pace in approving Biogen’s Spinraza (nusinersen) in December 2016, a first treatment for spinal muscular atrophy, which is often fatal for infants. More controversial was FDA’s approval of…
Article
Bioburden Control in the Biopharmaceutical Industry
Hughes, “Aseptic Processing of Biological Products: Current Regulatory Issues,” presentation at the WCBP 2016 Symposium (Washington, DC, 2016).
4. CFR Title 21, 210.1-3, 211.4-31.
5. FDA, …
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Managing Residual Impurities During Downstream Processing
In addition to these biologics-specific chapters from USP, FDA published draft guidance on elemental impurities in June 2016 (3) following the issuance in 2014 of the International Council for Harmoni…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
FDA approved the first Humira (adalimumab) biosimilar, Amjevita (Amgen), in September 2016, and it was the fourth biosimilar approved in the United States. The European Medicines Agency (EMA) started …
Article
Biosimilars to Drive Modern Manufacturing Approaches
1, 2016, and more are on the way: six companies had announced the submission of at least nine biosimilar applications as of the end of July 2016, and the agency is assisting with more than 60 biosimil…