What's New on the CBER Web Site 12/24/2001 through 12/28/2001

Smart technology, personalized medicine, and the customization of CDMO relationships are helping manufacturers meet shifts in client demand.

Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.

While little information is known about this particular case, its possible implications are far-reaching.

In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.

Outsourcing is booming across all platforms, from fill/finish to cell therapies, as companies pursue efficiency, scale, and strategic flexibility.

Mirvetuximab soravtansine, brand name Elahere, is the first licensed treatment for women with platinum-resistant ovarian cancer in the UK in more than 10 years.