Search results for " filterability"
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Mar 01, 2015
By Randi Hernandez
BioPharm International
Volume 3, Issue 28
Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product. Protein …
Article
Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain.
Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
Article
Filtration methods to overcome new challenges in viral safety
Read our article which summarizes the recent virus filtration regulatory changes in PDA Technical Report No. 41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filt…
Webcast
Virus safety challenges: get the job done!
In this free 1-day seminar you’ll learn how to conduct virus filterability trials, including prefiltration.
Article
Virus safety challenges: get the job done!
In this free 1-day seminar you’ll learn how to conduct virus filterability trials, including prefiltration.
Click here for more information
Article
Future-proof your AAV process with a complete producer cell line – just induce and grow
Stable producer cell lines helped to make mAb therapies the powerhouses they are today. To deliver on the promise of AAV-based gene therapy for prevalent diseases, we need similar technology. …
Article
Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…
Article
Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…