Video with Paul Pluta
EDQM Announces Digital Version of the European Pharmacopoeia
EDQM is providing the 12th edition of the European Pharmacopoeia as an all-digital, redesigned, user-friendly issue.
EMA Conditionally Authorizes Stem Cell Therapy for Blood Cancers
The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).
FDA Halts Clinical Trials That Send US Patient Cells to Foreign Labs
Some of the companies that received American samples, FDA said, are partially owned or controlled by the Communist Party in China.
Aragen to Commence GMP Manufacturing at India Biologics Facility in July 2025
The company’s successful completion of facility and equipment qualifications gives it another biologics manufacturing option alongside its United States campus in Morgan Hill, Calif.
Considerations for Quality Improvement of Cleaning, Disinfection, and Cleaning Validation in Biopharmaceutical Manufacturing, Part I: Facility and Cleanroom Cleaning Practices
This paper highlights considerations based on risk that ensure ongoing success as well as improvement when applying cleaning and decontamination principles for biopharmaceutical cleanroom surfaces.
Qualifying Expertise for Quality Support
Bringing in external expertise may be necessary when internal knowledge is lacking, but it is critical that any contract employee or consultant is comprehensively assessed to ensure the right person is employed.
