Search results for " productivity"
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Improved manufacturing agility and productivity
Biomanufacturing based on single-use technology offers great flexibility compared with traditional stainless steel facilities. Production lines can …
Article
Antibody Production in Microbial Hosts
Many advances such as translation region initiation (TIR) optimization, engineering of secretion pathways, and co-expression of molecular chaperones have been made for enhancing antibody productivity …
Article
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
Because the feed dilutes the culture and reduces product concentration, the use of lower feed volumes can improve overall process productivity as well.
One approach of decreasing feed vol…
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
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
As the cells are suspended in the liquid medium, they will be exposed to higher mechanical forces and risks of local oxidative stresses, which may lead to reduced growth and productivity.
In FBRs,…
Article
Ensuring Sterility in Small-Scale Production
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses how to ensure sterility when manufacturing small-scale parenteral batches.
By Susan J. Schniepp
Q. I am a …