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.
ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of control, and facilitate continual improvement. Embracing these objectives can be best achieved using the dual enablers, Knowledge Management (KM) and Quality Risk Management (QRM). The pharmaceutical...
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are highlights from the magazine ten years ago in 2011. Revisit articles on single-use in biomanufacturing, contained dust collection systems, manufacturing execution systems, and more.
Pharmaceutical Engineering® magazine is proud to announce the 2020 Roger F. Sherwood Article of the Year is “Implementation of a Formal Energy-Efficient Design Process” (Mar-Apr) by Aoife Hamill, BE MSc, John Hanley, PhD, MPhil, CEng, and Vincent Lane.