10.12.24 -- Outsourced Pharma Best Of September

The U.S. House of Representatives was hell-bent on sending a message to China – and all of us in the biopharma industry. Congress hopes that message – and real-life consequences – will be accomplished by successfully passing the BIOSECURE Act in a House vote.

How could I not ask him for an opinion regarding our vigorously pursued editorials on the WuXi Apptec–BIOSECURE Act. After all, Reza Oliyai has outsourced a myriad of development and manufacturing services to hundreds of CDMOs around the world. He did so at Gilead for decades, and since as the CEO  of his eponymous consulting company. His response did not disappoint.

The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.

Gain insight into how switching to a single-unit dose nasal sprayer carton reduced one company's material costs and significantly improved environmental sustainability throughout the product lifecycle.

Learn more about the comprehensive lifecycle management of reference standards, encompassing qualification, characterization, and storage procedures.

Discover examples of visible particle identification and the root cause investigation, along with a discussion of the performance of additional troubleshooting using advanced and innovative technologies.