Showing posts with label Biomanufacturing production issues. Show all posts
Showing posts with label Biomanufacturing production issues. Show all posts

Wednesday, September 30, 2015

Cell therapy companies must improve internal process development

By Brian Caine 
 
Michael Paglia, senior director of technical operations at Bluebird Bio, told attendees at Cell Therapy Bioprocessing & Commercialization that companies need to “better understand the evolution of the process”.

Paglia told a packed session on viral production that there is a “significant need to determine how to improve their internal process development”.

He reviewed a specific case focusing on the downstream process development of a lentiviral vector and how one company offset product loss in their downstream process.

Companies must also have “proven tech-transfer in order to ensure proper reproducibility whether the process is internal or outsourced”, he said.

Join the conversation on Twitter by following #IBC_CTB15


Share this article with your social network, just click below to share now!


Tuesday, December 10, 2013

Biomanufacturing Shows Signs of Maturity

Today, we feature an excerpt from our partners at Pharmaceutical Manufacturing's eBook Biopharmaceutical Manufacturing Trends 2013 Excellence Within a Rapidly Changing Landscape.  Download the full eBook here.  They will be joining us at Biopharmaceutical Development and Manufacturing Week this March 24-28, 2013 in San Diego, California.

Biomanufacturing Shows Signs of Maturity

In biopharmaceutical manufacturing today, quality management is critical for steering clear of production problems, capacity bottlenecks, and operation failures. The good news is that manufacturers appear to be doing a better job over the past 10 years. 
In or "9th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production", we evaluated, along with more than 80 other biomanufacturing trends, the frequency of batch failures among global biomanufactureres. We weighted information shared by 302 respondents to estimate the batch failure rate for the industry. Based on responses, batch failures occur on average every 60.3 weeks per facility. This is a significant improvement over last year's average of 54.5 weeks, and shows a continuing trend over the past five years. Indeed, in 2008, we found batch failures occur every 40.6 weeks. This means that in five years, the batch failure rate as improved by 49%
Download the Biopharmaceutical Manufacturing Trends 2013 eBook here.


Share this article with your social network, just click below to share now!