BioPharm International Editors

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

Part of the session "Transforming Medicine: Unleashing the Potential of Cell and Gene Therapies," Sadelain discusses CAR-T cells for immunotherapy and the future of cell/gene therapies.

The new guidance provides detailed recommendations to drug developers with a target of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

AstraZeneca has entered into a global exclusive license agreement with KYM Biosciences for CMG901, which is being investigated as a gastric cancer treatment.

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.