Search results for " process qualification" in Articles / App Notes
Article
Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
Article
Fluid Handling in Biopharma Facilities
Industry experts discuss challenges, trends, and innovations in fluid handling.
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling…
Article
Single-use Bioreactors Have Reached the Big Time
“Single-use bioreactors such as the iCELLis allow rapid process qualification, implementation, and commercialization, providing the speed-to-market that next-generation biologic manufacturers need,” s…
Article
Trends in Single-use Bioreactors
Representatives from industry supplier companies address innovations, reliability, barriers to adoption, and the role of singIe-use bioreactors in bioprocessing.
By: Randi Hernandez
Whil…
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
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
Article
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
Article
Host-Cell Protein Measurement and Control
Jun 01, 2015
By Fengqiang Wang, PhD, Daisy Richardson, Mohammed Shameem
BioPharm International
Volume 28, Issue 6, pg 32–38
Host-cell proteins (HCPs) constitute a major part of proce…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
Best Practices in Adopting Single-Use Systems
Key considerations for implementing single-use components or platforms when moving from research to process development.
The adoption of single-use systems in biopharmaceutical production or…