Continued Process Verification (CPV), the 3rd Stage of the FDA process validation guidelines, represents the Ship of Theseus in bioprocessing:
The bioprocess is validated and on the market, but it inevitably is subject to changes in supplies, raw...
FDA’s recent released Guidance for Industry on Data Integrity and Compliance with Drug CGMP Questions and Answers (CGMPs also known as current Good Manufacturing Practices), clarifies data integrity’s role for drugs and biologics as required in 21 CFR...
Eli Lilly and Company’s continuous manufacturing (CM) kits have proven to be an important manufacturing platform for the company’s oral solid dosage products (OSD). “CM is very important to Lilly as one of our proven manufacturing platforms for...
On 30 August, the US Food and Drug Administration (FDA) approved Novartis's Kymriah (tisagenlecleucel, CTL019), the first gene therapy for the treatment of pediatric and young-adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Kymriah belongs to a class of drugs...
Gilead Science’s 28 August purchase of Kite Pharma, Inc., one of the companies developing CAR T-cells, a therapy that harnesses the body’s own immune system to recognize and attack malignant cells, paid off in spades last week. On Wednesday, 18 October,...
ISPE released its Drug Shortages Prevention Plan yesterday during 2014 Annual Meeting in Las Vegas, Nevada. Regulators from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Medicines and Healthcare Products...
