Search results for "regulatory"
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Robust Optimization, Simulation, and Effective Design Space
Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulat…
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USP Stresses Pharmacopeial Standards at CPhI China
The seminar was designed to explain the latest quality standards and regulatory updates to the more than 120 participants. Topics included global harmonization with industry standards and regulations,…
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Host-Cell Protein Measurement and Control
Therefore, it is a regulatory requirement to monitor the removal of HCPs in drug product during bioprocess development.
HCPs are proteins produced or encoded by the host organisms used to produce …
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Technologies and Practices Must Evolve to Meet Demand
Regulatory issues and microbial contamination, however, were of greater concern for the 2015 survey participants. Producing high enough product yields, purifying high product yields, and protein aggre…
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Applying GMPs to the BioPharma Supply Chain
There is an acknowledged gap between current capabilities of many suppliers and what will be needed in the future to support the industry in an increasingly demanding regulatory and end-user focused m…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Furthermore, the characterization data obtained are essential for product development and regulatory acceptance. Characterization of multiple product batches is essential to demonstrate to the regulat…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
Development of clear, regulatory approval pathways for biosimilars in emerging markets is creating large, additional opportunities for biosimilar mAbs. Education of physicians, pharmacists, and patien…
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Elucidating Biosimilars Characterization
…IBRT (collectively referred to as NIBRT thereafter); Kamali Chance, PhD, head of global biosimilars regulatory strategy, Biosimilars Strategic Unit; Colin Vose, PhD, vice-president, Centre for Integr…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
…ars in the US are not necessarily technical challenges, says Levine, but rather more commercial and regulatory. “First of all, there is the 12-year data exclusivity period which means that a biosimil…
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PDA's Technical Report for Biotech Cleaning Validation
This report, more than 70 pages long, was created by a team of European and North American professionals from biotechnology manufacturers, cleaning-chemical suppliers, regulatory agencies, and consult…