Search results for " bioprocesses"
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
Bioburden Entry Points in Downstream Processing
If you work in bioprocessing, you are no doubt aware of the need to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved. Anastasia Lolas, for…
Poster
Rapid Process Development of a CIEX Step for a Biosimilar
When establishing purification processes for a biosimilar molecule it is important to develop steps that are scalable, selective, and cost-effective.
A cation exchange (CIEX) chromatographic ste…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Automated In-Line Buffer Preparation from Ready-Made Stock Solutions in a mAb Process Step
Buffer preparation is both time-and space-consuming and can easily become a challenge in biomanufacturing. This application note describes a lean approach to buffer preparation by implementing in-li…
Article
Immediate, Flexible Capacity with Hydrated Buffers and Process Liquids
Fluids used in bioprocessing are typically prepared in-house by hydrating powders purchased from suppliers. Historically, bioprocessing facilities have prepared buffers and process liquids in-house …
Article
Sources of Bioburden You Might Have Missed
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
The risk …
Article
Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …
Article
Single-use Bioreactors Have Reached the Big Time
Recipe functions and data acquisition and analysis capabilities, including most recently multivariate data analysis, allow for effective monitoring of bioprocesses and provide greater confidence in th…
Article
Reconciling Sensor Communication Gaps
By Angelo DePalma, Ph.D.
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors …