Search results for " biologics"
Article
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
Gregory Lane: Chris, the reason I moved into the drug product space was to get more involved in biologics and protein production, and upstream is a big part of that. As you mentioned with the perfusio…
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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
In contrast, all therapeutics proteins/non-Fc biologics are left without a generic affinity capture step. Development of an individual, multi-step chromatography downstream processing (DSP) for every …
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Although the industry as a whole has been slow to adopt these techniques, FDA actively encourages continuous production, and companies such as Sanofi and WuXi Biologics have made significant investmen…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
FDA, “Statement from FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research on New Policies to Advance Development of Safe and Effe…
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Tools and Processes for Mature and Emerging Therapies
Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) told the audience at an FDA Town Hall session that the agency is gearing up f…
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Moving PAT from Concept to Reality
In-line, at-line, and on-line
To understand the state of PAT technology development, it is necessary to understand the different types of PAT operations used in biologics manufacturing. In-line se…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
The reality, however, is that working with biologics is several orders of magnitude more complicated than it is for small molecules.
Proteins are subject to problems during post-translational modi…
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Modern Manufacturing Key to More Effective Vaccines
In 2017, FDA’s Center for Biologics Evaluation and Research (CBER) approved GlaxoSmithKline’s new Shingrix vaccine against shingles and a new recombinant hepatitis B preventive from Dynavax Technologi…