Search results for " bioburden biopharmaceuticals"
Article
Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…
Poster
Collaborating to address the bioburden challenge
Bacteria and their byproducts can negatively affect the safety and potency of a biopharmaceutical drug. At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batche…
Article
How to Address Bioburden Challenges: Insights and Tips
Bioburden control is an area of serious concern for anyone making mAbs or other biologicals. Manufacturers’ efforts to avoid microbial contamination are today being complemented by developments from…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Iss…
Article
Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…
Article
Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
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
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
Article
Biopharmaceutical Process Development: 2018 Lessons and 2019 Predictions
The biopharmaceutical industry continues to expand in new and exciting ways. What might be in store for 2019, and what important lessons should process developers take from 2018? Here, we look back …