Search results for " biologics" in Articles / App Notes
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
Platform Technologies Improve Protein Expression
Platform technologies facilitate development and accelerate commercialization of protein therapeutics.
By Cynthia A. Challener
Speed to market is essential in the biopharmaceutica…
Article
Process Chromatography Selection for Downstream Processing Applications
Separation Technologies
BioPharm: What are the most commonly used separation technologies for biologics that are not monoclonal antibodies (mAbs)?
Björkman (Cytiva): If one excludes mAbs, then…
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
In addition, the authors wish to recognize and thank Lonza Biologics (Slough, UK) for the licensing of and permission to modify the GS-CHO expression system.
References
1. J.M. Reichert, MAbs. 7…