Search results for "biologic"
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…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
… 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 in…
Article
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…
Article
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…
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…