Overcoming the 3 Challenges in Manufacturing Controls for Your Molecular Diagnostic Assay

By |May 21st, 2021|Controls and Standards, Manufacturing, Useful Tips|

As an assay developer, you understand the importance of having quality controls and standards for your assay, but what does it really take to manufacture them?  It may not be as easy as it appears and there are a number of questions beyond choosing t [...]

How to Compare Biotech Manufacturer Proposals: What You Need to Know

By |February 6th, 2020|Manufacturing, Useful Tips|

Comparing competing proposals is the final step in selecting your biotech contract manufacturing organization (CMO). While it may sound straightforward, due to a lack of industry standardization proposals can vary significantly between CMOs. Similar [...]

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 [...]

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 [...]

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

By |January 24th, 2019|Manufacturing, Useful Tips|

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 [...]

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