Continuous, CAR-T, & Oligo – Are You Ready for the Future of Biologics Manufacturing?
Vivianne J. Arencibia
Joseph C. Famulare
This year’s ISPE Biopharmaceutical Manufacturing Conference promises to deliver excellent content and is a must attend for anyone involved in the manufacture of biotech drugs in today’s fast changing environment. Building on the success of our previous conferences this ISPE signature event will cover every aspect from quality, regulatory, drug substance, to drug product, with an emphasis on advanced therapeutic medicinal products including CAR-T, cell and gene therapy, and personalized cancer vaccines. This conference will cover the waterfront from personalized medicines, oligonucleotides, and emerging technologies including continuous manufacturing.
Speakers include industry leaders in manufacturing, quality, regulatory, and academia. This includes prominent FDA speakers from both CBER and CDER. Presentations will be followed by interactive discussions on the challenges and opportunities in truly producing personalized medicines - one patient, one product, covering:
What will these facilities look like from a design, construction and location perspective?
How will the lines blur between development, clinical, and commercial?
What are the health authorities seeing as successes and opportunities in new license applications in light of current guidance and the rapid advancement of treatments and technologies?
Understanding the barriers and successes in implementing emerging technologies such as continuous manufacturing in drug substance operations
Participating in the industry-regulator interactive panel discussion
Signing up for a facility tour
The pharma industry is already under transformation and much more is on the way. Whether you are in a small or large company, start-up or major biopharmaceutical manufacturer, are new or very experienced in the industry, this conference is necessary for you to attend to keep pace with the advancements the industry is bringing in manufacturing technology, newer products, and ultimately patient treatments.
Unlike other Biopharmaceutical manufacturing conferences you may have attended, this conference has a faculty bringing scientific, manufacturing, academic, and health authority experience, and is backed by ISPE’s body of knowledge represented by our expert committees and publications including our Baseline Guides and Good Practice Guides.
There is still time to register however it is getting close so reserve your spot now. If you were waiting for a special invitation, this is it!
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from October 2019. See leading facilities, break-through therapies, innovative technologies, and more for what the pharmaceutical industry was reading in October.
Raise your hand if you often speak before you think. If this is you (as it’s often me), I encourage you to slow down and consider your words carefully. What we say in conversation and presentation speaks volumes about our level of confidence and how we...
The Aseptic Processing is facing the next generation of pharmaceutical products and GMP requirements. The Annex 1 draft is in the final stage and we expect the publication before the next ISPE Aseptic Conference in North Bethesda, MD. The Annex2/PICs...