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 [...]
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 [...]
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 [...]
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 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 [...]
Being a biotech startup is exciting. Your company is young, energetic, and full of potential. However, your company is likely lacking in two key areas: cash and time. Startups have the difficult task of scaling quickly to profitability, while trying [...]
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 [...]
The sequencing service lab market is hot right now, with over 75,000 genetic tests already available and a predicted clinical sequencing market value of $7.7 billion by 2020. Rising maturity of analysis techniques coupled with decreasing sequencing c [...]
Location, location, location. Important for real estate, but does location matter when choosing a contract manufacturing partner? Absolutely. Breaking into an international market is challenging. A contract manufacturing organization (CMO) in your ta [...]
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 [...]
