Search results for " usp" in Articles / App Notes
Article
USP Publishes Monoclonal Antibody Guidelines
In 2012, USP started working on a clearly defined set of quality expectations for recombinant therapeutic mAbs, United States Pharmacopeia (USP) General Chapter “Analytical Procedures for Recombinant…
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USP Stresses Pharmacopeial Standards at CPhI China
Keynote speakers included former FDA officials, USP experts, members of the Chinese Pharmacopoeia Commission, and senior pharmaceutical executives.
The seminar was designed to explain the latest q…
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What’s In a Name? For Biosimilars, A Lot
While FDA and USP work closely on nomenclature policy, “USP naming is not directly implicated under either USP rules, or Federal law, until a compendial standard applies to an article,” according to p…
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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In addition to these biologics-specific chapters from USP, FDA published draft guidance on elemental impurities in June 2016 (3) following the issuance in 2014 of the International Council for Harmoni…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Osmolality method
Osmolality was performed essentially following USP (15).
Glucose method
Glucose standard curve—A stock solution of 100 mg/mL glucose was diluted with HPLC-grade water to…
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Establishing Acceptance Criteria for Analytical Methods
• USP : “The validation target acceptance criteria should be chosen to minimize the risks inherent in making decisions from bioassay measurements and to be reasonable in terms of the capability of the…
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Quality by Design and Extractable and Leachable Testing
Glass components should minimally meet hydrolytic resistance and etching criteria outlined in USP 37 Containers—Glass (3). Gross toxicity screening should also be confirmed for plastic and elastomeri…
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Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
Article
Global Expansion Shapes Drug Oversight
…and safety standards; a recent five-year extension of the program will provide up to $75 million for USP to provide technical assistance to government regulatory systems in establishing domestic qual…
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Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…