Search results for " 2015"
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
FDA, Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Rockville, MD, April 2015).
16. M. Schraeml and M. Biehl, Antib. Methods Protoc. 901,…
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
EMA, Guideline on Quality, Non-Clinical and Clinical Aspects Microbial Contamination of Gene Therapy Medicinal Products(London, May 2015).
17. EMA, Guideline on the Use of Bovine Serum in the Ma…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
…
Article
Unifying Continuous Biomanufacturing Operations
described the potential set-up for the end-to-end production of a mAb in a 2015 study, in which the pilot plant moved the bottleneck from downstream back to the upstream processes. In the study, it wa…
Article
Drug Quality Key to Innovation and Access
As 2016 came to a close, FDA officials reported that new drug approvals for the year would fall far short of the near-record set in 2015, raising concerns about current incentives and regulatory proce…
Article
Advancing Single-Use Technology Through Collaboration
A Study of Biotherapeutic Developers and Contract Manufacturing Organizations” (April 2015), www.bioplanassociates.com/publications/12th_Biomfg_Table_of_Content.pdf, accessed Sept. 2, 2016.
4. W. …
Article
Establishing Acceptance Criteria for Analytical Methods
USP, Validation of Compendial Procedures, USP 38 (USP, 2015).
6. FDA, Analytical Procedures and Methods Validation for Drugs and Biologics, Guidance for Industry (CDER, July 2015).
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Article
Reporting Quality Metrics to FDA
Since the publication of FDA’s draft guidance, Request for Quality Metrics, Guidance for Industry (1), in July 2015, we have been debating how to best capture and report quality metrics in our organiz…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
1, 2015) pp. 541–543.
16. J.J. Carroll, N. Smith, and A.J. Babson, Biochem. Med. 4, pp. 171–180 (1970).
17. M.W. Slein, Methods of Enzymatic Analysis, H.U. Bergmeyer, Ed. (Academic Press, New …