A derivative of a trendy if not overused moniker, used by many other industries to convey a new start, a new future, and substantial change from the past. Is biopharma manufacturing really at such a juncture? The committee members organizing ISPE’s 4th Annual Biopharmaceutical Manufacturing Conference think so! We’ve lined up biopharma industry thought leaders, key regulators, and innovation practitioners who are forging the future of biopharmaceutical production.
Need more evidence? There are 308 active or planned gene therapy clinical trials listed at ClinicalTrials.gov. How about 123 Antibody Drug Conjugate studies! These new modalities require a different manufacturing approach; creating challenges that require engineers, scientists, and operations professionals to learn new approaches and adapt old ones.
There is a lot of change on the horizon for the biopharmaceutical industry and staying at the forefront is of utmost importance. Please join me in Boston, 18 – 20 June, where thought leaders will inspire, practitioners will instruct, and you will be immersed in BioPharma 4.0. Boston is a global hub for biotechnology innovation and production. Early registration has demonstrated global interest, and the high density of local firms will provide invaluable technical and business networking opportunities.
Your journey to the future begins in Boston this June.
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ISPE published the 2nd Edition of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring in December. The international team of experts working on the revision felt it was time to update the Guide due to the increasing complexity of...
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from December 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.