Search results for " specification" in Articles / App Notes

Article Good Manufacturing Practices: Challenges with Compliance
WrightStudio/Stock.Adobe.com The complexity of biologics and the use of new technologies present challenges for complying with CGMPs. By Lauren Lavelle …

Article Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …

Article A Look at the Affinity Chromatography Landscape
A Look at the Affinity Chromatography Landscape New ligands are being developed to meet the separation and purification needs of next-gen biologics. By Cynthia A. Challener …

Article Using Multiple Techniques in Biosimilar Analysis
ICH, Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (ICH, March 10, 1999), www.ich.org 2. W. Curtis Johnston, Proteins 35 (3) 307–312 (May 1999…

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 Generating a Fully Processed Antibody
The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality. B…

Article Analysis of Glycosylation in Biosimilars
…cess, and fulfill the requirements of the International Council for Harmonization’s (ICH’s) Q6B, Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products guide…

Article Design and Qualification of Single-Use Systems
…APIs do not alter the quality of the intermediates and APIs beyond the official or other established specifications” (2-4). Fortunately, established SUT manufacturers have significant experience …

Article Nurturing Knowledge from Disparate Data Streams
For lot release, once a specification (identify, purity, physical form, etc.) has been established and test methods validated for a drug substance, there are many human intervention steps involved to …

Article CoAs Help Secure the Supply Chain
The International Pharmaceutical Excipients Council defines a CoA as “a legal document that certifies the quality of the excipient and demonstrates the batch conforms to defined specifications, has be…

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