Search results for " biologic" 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
Unlike other biological drug products such as therapeutic proteins, monoclonal antibodies, or vaccines, drugs based on living cells are by nature uniquely vulnerable to supply chain complications and …
Article
Tools and Processes for Mature and Emerging Therapies
By Rita Peters
Conference sessions and new technology introductions at recent trade shows addressed ongoing and emerging trends in the development and manufacture of biologic-based drugs. While …
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
…est in platform technologies for protein expression that will not only facilitate the development of biologic drug candidates, but also increase yield and speed to market.
A platform of benef…
Article
Process Chromatography Selection for Downstream Processing Applications
Some factors companies may consider when selecting a separation technology include the stability of the biologic, buffer compatibility, and ease of scale-up. In this roundtable discussion, industry ex…
Article
Analysis of Glycosylation in Biosimilars
…quence is the same, the glycosylation pattern may be different, potentially altering the protein’s biological properties. It is, therefore, important to use a cell line that produces an appropriate g…
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…