Search results for " monograph"
Article
Ensuring the Quality of Biologicals
began elaborating monographs on biologicals as an early priority with the first biological monographs on vaccines for human use, immunosera, and immunoglobulins appearing in Volume 2 of the first edit…
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Setting Standards for Biotech Therapeutics in India
Over time, the IP committee has deleted monographs for products that have become obsolete and added monographs based on the therapeutic merit and medical need (3).
The IPC was established in 2005 …
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What’s In a Name? For Biosimilars, A Lot
It has been reported that FDA determined that the United States Pharmacopeial Convention’s (USP’s) monograph for filgrastim does not apply to the first-ever approved biosimilar product, Zarxio (filgra…
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A Look into the Future of Biopharmaceutical Quality
Many monographs utilize traditional high-performance liquid chromatography (HPLC) for testing. Companies have migrated to ultra-high-pressure liquid chromatography (UHPLC) and other sophisticated meth…
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Managing Residual Impurities During Downstream Processing
USP monographs and associated reference standards, according to Atouf, can be used to control product variants during the lifecycle of therapeutic peptide and protein products.
“USP continues to de…
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USP Publishes Monoclonal Antibody Guidelines
USP has been involved in developing quality standards for biologics as part of its expanding portfolio of monographs and general chapters for a long time. In 2012, USP started working on a clearly def…
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PDA's Technical Report for Biotech Cleaning Validation
29: Points to Consider for Cleaning Validation (2) and the 1996 Technical Monograph, Cleaning and Cleaning Validation: A Biotechnology Perspective (3). The report uses a life-cycle approach to biotech…
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Eliminating Residual Impurities Starts with a Strategic Plan
European Pharmacopoeia monograph (3) and United States Pharmacopeia General Chapter (4) provide specific guidance on the control of host-cell-derived process-related impurities using appropriate ris…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
European Pharmacopoeia, Monograph: Bovine Serum, 01/2008:2262, pp. 1506–1507.
9. ICH, Q5A (R1) Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products D…
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Innovative Therapies Require Modern Manufacturing Systems
FDA, 21 CFR Parts 300, 330, and 610, Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter …