Search results for "biotech" in Articles / App Notes
Article
Fluid Handling in Biopharma Facilities
… hunter; Thorsten Peuker, vice-president integrated solutions/project execution at Sartorius Stedim Biotech; and Tony Butler, single-use applications engineer at AdvantaPure, to get insight on the ch…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
This specificity is of particular relevance to the production of biotech therapeutics, which require high standards of purity. However, development and optimization of a process chromatography step pr…
Article
Use of Multivariate Data Analysis in Bioprocessing
Singh
BioPharm International
The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare costs have motivated biotech manufacturers to focus on process opti…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Changes in OPQ’s Office of Biotechnology Products (OBP), for example, aim to enhance its capacity for assessing the quality and safety of a broader range of biotech therapies in development or under r…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Most major and mid-size biotech companies know what QbD means and how to go about implementing it and have already incorporated most of the QbD concepts into their approaches towards process and produ…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical and biotechnology companies making products for human use have an obligation to ensure that their products are safe, effective, meet established regulatory expectations and licenses, an…
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
Overall process scalability and robustness, says Todd Sanderson, senior R&D manager for Pall Biotech, are dependent on the performance of the bioreactor whether it is adherent- or suspension-based. “T…
Article
Can Vaccine Development Be Safely Accelerated?
The biotech was the first to advance a vaccine (INO-4700) against MERS-CoV into human testing and is currently preparing to initiate a Phase II trial for INO-4700 in the Middle East. This vaccine, how…
Article
Improving Upstream Predictability
By Agnes Shanley
In the earliest days of biotech, developers often struggled to sustain conditions that would optimize cell health and product yield. Today, better understanding of cells and …
Article
Moving PAT from Concept to Reality
… potential is not yet being used,” agrees Svea Grieb, product manager for PAT at Sartorius Stedim Biotech.
In many cases, Makowiecki adds, reliable, low cost, on-line/at-line analytical sensors n…