Risk Evaluation in Pharmaceutical Fill/Finish Sourcing
Tips for Risk Evaluation in Pharmaceutical Fill/Finish Sourcing In this post we focus on the critical decision pharmaceutical companies face regarding their fill/finish needs: whether
Category: Useful Tips
Overcoming Challenges in Combination Product Manufacturing
Addressing novel modalities create the largest challenges in combination product manufacturing. Challenges in combination product manufacturing must overcome what has traditionally been two different manufacturing
FDA Gives Guidance on Transitioning EUA Status for COVID-19 Medical Devices: What You Need to Know
EUA Status for COVID-19 – Getting Back to Normal Operations The FDA recently recommended that “manufacturers of devices authorized under EUA’s (to) plan now, while
Overcoming the 3 Challenges in Manufacturing Controls for Your Molecular Diagnostic Assay
What are the challenges when manufacturing controls? As an assay developer, you understand the importance of having quality controls and standards for your assay, but
How to Compare Biotech Manufacturer Quotes: What You Need to Know
Comparing competing biotech manufacturer quotes is the final step in selecting your biotech contract manufacturing organization (CMO). While it may sound straightforward, due to a
When is the Right Time to Select a Biotech Contract Manufacturer (CMO)?
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
The Make Versus Buy Dilemma: Evaluating your Aseptic Fill/Finish Manufacturing Strategy
Every biopharma company is eventually faced with the “make versus buy” decision – should they do the fill/finish manufacturing of their drug product in-house or
Life Science Manufacturing Automation and Scale-up Strategies: Your Ultimate Guide
Questions asked when planning Life Science Manufacturing Automation and Scale-up In life science manufacturing automation and scale-up is challenging. When picturing a manufacturing line, you
Maximize Biotech Startup Growth through Strategic Moves
Strategic plays to grow your biotech startup Being a biotech startup is exciting. Your company is young, energetic, and full of potential. However, your company
How QSR-Compliant Medical Device Companies Can Switch to ISO 13485:2016
Preparing now for the switch to ISO 13485:2016 For decades, there has been a divide in the medical device regulatory landscape. While the U.S. Food