Search results for "quality" in Articles / App Notes
Article
Concentrating Feed—an Applicable Approach to Improve Antibody Production
These approaches did not affect product quality and were effective for multiple cell lines and applicable for large-scale manufacturing.
Recombinant protein production in the biopharmaceutical …
Article
Raw Material Variability
Raw material variability may lead to quality compliance issues, process inconsistency, or bioprocess productivity problems. Many of these issues would be upstream in the cell-culture or fermentation s…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
…:
• Preventing entry of contamination into production processes by ensuring the quality of raw materials
• Detecting contaminants by characterization of cell banks/virus seed stocks a…
Article
CoAs Help Secure the Supply Chain
The International Pharmaceutical Excipients Council defines a CoA as “a legal document that certifies the quality of the excipient and demonstrates the batch conforms to defined specifications, has be…
Article
Tools for Continuous Bioprocessing Development
Bioprocess development requires interaction between manufacturer and creator because biopharmaceutical product characteristics and quality are affected by the manufacturing process.
Reliable and st…
Article
Robust Optimization, Simulation, and Effective Design Space
Establishing a clear line of sight between critical quality attributes (CQAs), process parameters, and material attributes is a primary goal of drug development. Even though there are ICH guidance doc…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
…esents the challenges associated with changing any process, including the risk of affecting product quality in some way. Fortunately, by working closely with tools and technologies suppliers and the …
Article
Use of Multivariate Data Analysis in Bioprocessing
The increasing use of MVDA has also been fueled by the increasing acceptance of quality by design (QbD) and process analytical technology (PAT) among regulators and the biotech industry. Implementatio…
Article
Modular Manufacturing Platforms for Biologics
There are numerous benefits related to quality control with building and qualifying units off site. If a full module is unrealistic because of budget or existing architectural constraints, a piecemeal…
Article
Fermentation for the Future
Drivers of new technology development in microbial fermentation are similar to those for cell-culture processes and include reducing costs, increasing efficiency/productivity, and enhancing quality, s…