Search results for " biologic" in Articles / App Notes
Article
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
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Interestingly, FDA issued a new draft guidance for industry on Analytical Procedures and Method Validation for Drugs and Biologics early this year (1). The new draft guidance supersedes the 2000 draft…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…
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The Development and Application of a Monoclonal Antibody Purification Platform
The following article describes the development of a purification platform for monoclonal antibodies (MAbs) at Pfizer's Global Biologics division, including how the individual unit operations have bee…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
…t because every sample that has to go to an analyst, whether it's a small molecule or a protein or a biologic, takes time to run on a system. It takes a dedicated person to run that sample. The PAT i…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Vaccine experts at the Center for Biologics Evaluation and Research (CBER) worked overtime to clarify the size and diversity of efficacy trials and key analytical assessments needed to gain EUA status…
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Innovative Chromatography Resins Can Improve Purity and Quality
Ongoing downstream challenges
Constraints still remain in downstream processing of mAbs, which continue to be the most successful segment of biological molecules in the market in terms of required…