When is the Right Time to Select a Biotech Contract Manufacturer (CMO)?

By |October 22nd, 2019|Manufacturing, Useful Tips|

Every journey to contract manufacturing is unique. Some biotech companies know, at the start, they want to work with a contract manufacturing organization (CMO), while others choose to engage a CMO later in the product design process or even after pr [...]

Make Versus Buy: Evaluating your Aseptic Fill/Finish Manufacturing Strategy

By |October 9th, 2019|Drug Product Manufacturing, Useful Tips|

Every biopharma company is eventually faced with the “make versus buy” decision – should they fill/finish their drug product in-house or outsource? Complicating things further, a third option also exists to outsource a portion while retaining some i [...]

Scale-up and Automation Strategies in Life Science Manufacturing

By |September 17th, 2019|Manufacturing, Useful Tips|

Scale-up and automation in life science manufacturing is challenging. When picturing a manufacturing line, you likely conjure up images of automated multi-function equipment or deft robotic arms. However, for the vast majority of life science compani [...]

New manufacturing strategies for the precision medicine future

By |July 11th, 2019|Drug Product Manufacturing|

Blockbuster drugs and one-size-fits-all treatments now share portfolio space with highly targeted therapies for smaller patient populations. This new era is an opportunity for savvy companies to create greater value, both for patients and themselves. [...]

How QSR-Compliant Medical Device Companies Can Switch to ISO 13485:2016

By |June 26th, 2019|Certifications, QA/QC, Useful Tips|

For decades, there has been a divide in the medical device regulatory landscape. While the U.S. Food and Drug Administration (FDA) has considered their Quality System Regulation (QSR) to be the minimum criteria for medical device manufacturing since [...]

Selecting the Right CDMO Partner – Three Keys to Success

By |May 16th, 2019|Drug Product Manufacturing|

Outsourcing pharmaceutical manufacturing is becoming essential to remain competitive in the industry. The rise of small-batch personalized medicines and “virtual companies” are key drivers to retain flexible, external manufacturing capabilities. With [...]

Mission Bio Partners With LabCorp to Accelerate Targeted Drug Development with Single-Cell Genomics

By |March 28th, 2019|News and Announcements, Press Release, Supply Chain|

Following earlier LabCorp strategic investment, Mission Bio single cell-sequencing technology will be used by LabCorp to support clinical trials, along with the evaluation of potential applications in clinical diagnostics and companion diagnostics de [...]