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.
Continued Process Verification (CPV) was introduced roughly 12 years ago by the FDA as a third stage in the guidance on the process validation life cycle. In addition to being a mandatory requirement for the pharmaceutical industry, CPV can also provide valuable information to improve the quality and consistency of products. There may be limited data available when a process is designed and...
At ISPE, our commitment to advancing the pharmaceutical industry has always revolved around delivering gold-standard Guidance Documents — a trusted source of information that’s been a helping hand for professionals like you to rely on when forging new paths and exploring uncharted territory . In the ever-evolving landscape of pharmaceutical and scientific advancements, we understand that how...
The Facility of the Year Award (FOYA) Social Impact category recognizes companies that accelerated a shift to sustainable facility design, intended to ensure the effective use of energy, minimize waste, reduce carbon footprint, incorporate green manufacturing techniques, and reduce environmental impact.