Search results for "biologic"
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Patenting Prospects for Cell-Based Therapies
Indeed, it may be the case that regulatory exclusivity—analogous to the 12-year market exclusivities for biologic drugs provided by the Biologics Price Competition and Innovation Act (BPCIA)—will be m…
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Impact of Media Components on CQAs of Monoclonal Antibodies
These modifications can profoundly affect protein quality relevant to clinical efficacy, safety, and half-life of biologics (1). Mammalian cells meet these criteria quite efficiently by virtue of thei…
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Establishing Acceptance Criteria for Analytical Methods
• FDA, Analytical Procedures and Methods Validation for Drugs and Biologics (6): “An analytical procedure is developed to test a defined characteristic of the drug substance or drug product against es…
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Real Time Continuous Microbiological Monitoring
By Claudio Denoya
Nonviable particulate and viable microbiological surveillance are used to evaluate the design and control of a current good manufacturing practice (cGMP)-manufacturing environmen…
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Efforts Accelerate to Streamline Postapproval Change Process
…omes to market to improve products and systems and ensure reliable supply of high-quality drugs and biologics that meet regulatory standards. With more breakthrough and critical therapies gaining fas…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Similar cell-culture media may be used simultaneously in one or few biological processes at a drug product manufacturing facility. As per Code of Federal Regulations (CFR) 211. 84, each media needs to…
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Biopharma in 2015: A Year for Approvals and Innovations
Twenty approvals (39%) went to biological drugs—up from 35% in 2014 and 22% in 2013—which confirms the growing importance of biopharmaceuticals in the industry pipeline.1
Process Development Forum …
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Host-Cell Protein Measurement and Control
The HCP composition and abundance are unique to their respective host and the manufacturing process used for biologics production. Meanwhile, different host cells and manufacturing processes may produ…
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Challenges in Analytical Method Development and Validation
Interestingly, FDA issued a new draft guidance for industry on Analytical Procedures and Method Validation for Drugs and Biologics early this year (1). The new draft guidance supersedes the 2000 draft…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.
This in…