Data Integrity Challenges in Manufacturing

The new building will create 150 new jobs and expands total production area to nearly 12,000 square meters.

This podcast explores the challenges of and the progress made so far by the biopharma industry toward alternative drug delivering methods for biologic drugs.

The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

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.

The agreement, which covers a period of five years, has been designed to offer a turnkey service to companies seeking faster time to market for ADCs and bioconjugates.