Search results for " biologics"
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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
…ough an appropriate detection cell, resulting in the real-time detection of both inert particles and biologics such as bacteria, yeasts, and molds. Fluorescent (or fluorophore) dyes (molecules) can a…
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Efforts Accelerate to Streamline Postapproval Change Process
…comes 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 fa…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
However, this approach cannot be easily employed for media used in the manufacture of biologics, which might differ only by one additional component or by a concentration of similar components.
NI…
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Biopharma in 2015: A Year for Approvals and Innovations
The approval came via the new biosimilars pathway established under the Biologics Price Competition and Innovation Act. As of September 2015, FDA received six biosimilar applications to reference prod…
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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 practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
A…