BIOPROCESS OUTSOURCING FEATURED ARTICLES
At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.
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New Podcast: Building Blocks Of The Biopharma Business
We just launched the first full episode of the Business of Biotech podcast, a series purpose-built for the leaders of new and emerging biopharma companies. Here’s a recap of the first episode with industry icon Allan Shaw, highlighting the season to come and offering some strategic, straightforward advice for new biopharma leaders.
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Outsourcing Insights From A Tech Transfer Veteran
Explore tech transfer expert Anthony Grenier's opinions on the most common mistakes he sees, how to avoid them, and planning ahead to beat the CMO capacity crunch.
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DARPA’s Challenge: Manufacture A Biopharmaceutical In Less Than 24 Hours
In order to ensure American soldiers fighting in remote locations overseas can receive the biopharmaceuticals they need on time, Defense Advanced Research Projects Agency (DARPA) created a program called Biologically-derived Medicines on Demand (Bio-MOD). The goal of Bio-MOD is to build a system that has the ability to create an on-demand biopharmaceutical in less than 24 hours. I spoke with one of the teams working on this effort about how they intend to accomplish this and what it could mean to the future of the industry.
BIOPROCESS OUTSOURCING WHITE PAPERS & CASE STUDIES
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The Client Experience—Key to a CDMO’s Success
In the dynamic contract development and manufacturing organization (CDMO) industry, client-focused businesses succeed in retaining and growing our client base by delivering on project objectives and satisfying a client’s expectations.