Search results for " comparability"
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
The aim of this white paper is to demonstrate how Cytiva single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion around modern vacci…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
By Cynthia A. Challener
For a vaccine to be effective, the components of the disease o…
Article
Gene Therapies Push Viral Vector Production
Gene Therapies Push Viral Vector Production
Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable?
By Feliza Miraso…
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
…
Article
mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
Article
Vaccine Development and Production Challenges Manufacturers
These would facilitate comparability studies for eventual licensure of the vaccines from GSK and Merck, as well as one being developed by Johnson & Johnson/Bavarian Nordic. A related effort at BARDA a…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
The data obtained from analysis of the CQAs of further batches or reference materials in parallel can be used to provide an assessment of comparability in terms of batch to batch or indeed biosimilar …
Article
Driving Improved Access to Biosimilars
The agency also published draft guidance on the analytical methods to be used to establish biosimilar comparability and quality (12). According to reports on May 13 and May 21 in the Regulatory Affair…
Article
Biopharma Seeks Balance
Biopharma Seeks Balance
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
By Rita C. Peters
…
Article
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
This article highlights 15 years of changes in biopharmaceutical manufacturing.
By Ronald A. Rader, Eric La…