Yearly Archives: 2019

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, Tips and Tricks|

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 [...]

Facility of the Future: Our takeaways from the ISPE Aseptic Conference 2019

By |March 27th, 2019|Conference, Drug Product Manufacturing, Manufacturing|

The always-essential 2019 ISPE Aseptic Conference was held in North Bethesda, MD and we were there to assess the trends, check out the leading-edge sessions, and share lessons with industry leaders. Read on to find out what we found interesting or co [...]

Preparing for an Economic Downturn in Biotech: Lessons from the Past

By |January 24th, 2019|Business Development|

In 2008-2010, the economic downturn in biotech wreaked havoc on the unprepared industry. Fast forward a decade, and even though 2018 set a record in industry venture capital with over 700 deals and $17B funded, caution is in the air. Uncertainty exis [...]