Are you working on these ATMP's or clearing a path to continuous biologics manufacturing? ISPE invites you to submit a proposal for our 2018 ISPE Biopharmaceutical Manufacturing Conference , December 10-12, Huntington Beach, CA
The 2018 ISPE Biopharmaceutical Manufacturing Conference focuses on the quickly evolving science of biologics manufacturing for new modalities, and the novel technologies that leverage existing capacity and move us towards continuous manufacturing. Share your expertise and help your peers prepare to manufacture these novel medicines and deliver on our promise of supplying life changing medicines to patients across the globe.
The call for proposals is open until May 30, 2018.
I speak for all the conference committee volunteers when I say we look forward to reading your proposals and learning how you are propelling the industry forward.
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...
To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...