Search results for " specification"
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
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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
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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…