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.
What justifies the mantle ‘4.0’? Perhaps nothing demonstrates that more than this press release from BiosanaPharma noting regulatory approval to dose clinical patients with a biosimilar produced through a fully continuous process. The small molecule sector climbed this mountain a couple of years ago and left a trail of bread crumbs for biopharma to follow. It will take commitment, a willingness to accept risk, and perhaps most of all, an organization-wide paradigm shift away from our comfort zone. Mark Witcher, Consultant with 35+ years of experience in biopharmaceutical, pharmaceutical, and medical device industries, speaks to this in his article on "The Facility Challenges of Developing a Continuous Process Based on a Biopharmaceutical Product". Collaborations will help spread the risk (and reward), witness WuXi and Pall’s collaboration, and their recent 50g/L productivity success.
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.