Search results for "pharmacopeia"
Article
Setting Standards for Biotech Therapeutics in India
The scope of activities at IPC along with the complexities associated with biotech therapeutics make it a necessary requirement that the various pharmacopeial agencies work together with a collaborati…
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Microbiological Testing: Time is of the Essence
As a result, microbiological testing using rapid nucleic acid methods is allowed in the pharmacopeias, while polymerase chain reaction (PCR) methods for mycobacteria detection, which typically take on…
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HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
Guidelines for validating analytical methods have been published in the US Pharmacopeia,10 by the US Food and Drug Administration,11,12 and in published reviews.13 The guidelines published by the Inte…
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Assessing Manufacturing Process Robustness
The Stage 3a monitoring measures are developed in line with upcoming revisions to ICH Q2/Q14 and the proposed United States Pharmacopeia General Chapter framework for analytical QbD which requires id…
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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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Automating the Biomanufacturing Process
One supplier has extended and improved its sensor portfolio, by, for example, including a sensor that measures biomass in the United States Pharmacopeia bags used for rocking motion-based bioreactors …
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A Look into the Future of Biopharmaceutical Quality
An example is the applicability of pharmacopeial methods for product testing. Many monographs utilize traditional high-performance liquid chromatography (HPLC) for testing. Companies have migrated to …
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Impurity Testing of Biologic Drug Products
USP, Chapter , “Biological Assay Validation,” USP 35–NF30 (US Pharmacopeial Convention, Rockville, MD, 2011).
3. USP, Chapter , “Analysis of Biological Assays,” USP 35–NF30 (US Pharmacopeial…
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Development of Purification for Challenging Fc-Fusion Proteins
High-throughput screening: All chemicals (MilliporeSigma) were of United States Pharmacopeia or multi-compendial grade. For each sub-step, 1 mL of solution was in contact with 100 µl of resin. Sixty p…
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Managing Residual Impurities During Downstream Processing
…y medicines,” according to Fouad Atouf, vice-president of global biologics with the United States Pharmacopeial Convention (USP). “They are intended,” he adds, “to support and complement regulatory a…