Search results for " biologics" 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
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Interestingly, FDA issued a new draft guidance for industry on Analytical Procedures and Method Validation for Drugs and Biologics early this year (1). The new draft guidance supersedes the 2000 draft…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…
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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
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 …