The adoption of single use bioreactor (SUB) technology continues to increase in the biologics manufacturers we work with. Initially confined to research and process development applications, we find more companies are beginning to apply disposable technologies to clinical and even commercial applications. Moreover, users of this technology are reporting that SUBs provide comparable results to stainless steel systems across several critical dimensions. As early adopters have overcome their initial concerns through experimentation, it appears that disposable bioreactor technologies have now reached an inflection point towards becoming more viable clinical and commercial production systems.
(more…)
Posts Tagged ‘Manufacturing’
Single Use Bioreactors – The New Kid Grows Up
Monday, October 4th, 2010Biopharmaceutical Manufacturing Gaffes in 2010: Why It’s Time To Learn From Failure
Monday, August 2nd, 2010The ideals of reliability and quality (which I have come to learn is a metaphysical concept) are two distinct topics that have been top of mind lately. Perhaps it’s due to the fact that as I am getting older, my expectations for dependability have increased dramatically. Or perhaps it’s the fact that I just left my mechanic in a vapid attempt to solve a car problem that seems to defy all mechanical logic and human comprehension. So in embracing these two themes, it’s probably high time to evaluate recent manufacturing news and diagnose what is happening, or quite simply, what is not happening.
(more…)
News Analysis-Manufacturing Problems Prevent Drug Approval
Monday, March 29th, 2010In February, Cadence Pharmaceuticals’ pain and fever drug Ofirmev was not approved by federal regulators because of manufacturing problems at a contract manufacturing facility where the drug is made. Many of our clients outsource manufacturing and run the risk of becoming another Cadence – held up at the approval stage for reasons that have nothing to do with the safety and efficacy of the product. (more…)
