04.11.24 -- From Ally To Adversary: BIO's Swift Rebuke Of WuXi

In the aseptic drug-filling process for biotherapeutics, your company may find it challenging to meet regulatory compliance standards, putting the safety and effectiveness of your products at risk. Join us and gain valuable insights into enhancing the efficiency and reliability of the drug product manufacturing process. Learn innovative strategies and best practices from industry experts to refine your pharmaceutical production methods. Click here to learn more.

Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks. 

Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.

Monoclonal antibody (mAb) success hinges on choosing the right cell line. Learn how making an informed decision helps to lay the foundation for a successful mAb development project, unlocking its full potential.

While a few red flags are common during any submission, several occurring in concert can precipitate a submission crisis. Discover how these can be avoided in this article.

Learn about best practices for cell bank manufacturing, how to get the most out of your cell bank, the future of closed processing in line with Annex 1, and more.

Outsourcing is now a true collaboration in which innovators and CDMOs co-create the future of medicine. Explore how the right CDMO can help sponsors unlock the full potential of their biotherapeutics.

Industry experts discuss best practices and tips across a range of topics, including program management, automation, and secondary services.

The pathway from early clinical phases to commercial is not straightforward, particularly for complex sterile injectable products. It is important to have a wide range of specialized capabilities to keep pace with the rapidly evolving market. Global Pfizer experts will explore key aspects of the sterile injectable journey, including factors to consider during the development and tech transfer stages. Click here to learn more.

BD Physioject 1 mL Disposable Autoinjector is an easy-to-use autoinjector designed to deliver fixed dose injections subcutaneously.

FUJIFILM Diosynth Biotechnologies is building the largest end-to-end CDMO facility for biologics in North America.

The GS Xceed Gene Expression System is a comprehensive toolbox for development of biologics that has been used to develop not only monoclonal antibodies but also a wide variety of new molecular formats.