08.26.24 -- Clinical Trials In China Reboot BIOSECURE Act

Often, a CDMO partner is selected after a single recommendation or after being approached by a business development representative. There's a more pragmatic way to approach the process.

After four decades in the biopharma industry, including at NIH, Elan Pharmaceuticals, and Gilead Sciences, Nils Olsson may be undertaking his most complex role: continue to develop and supply vital technologies and pathogen-reduced blood components to blood centers, hospitals, and patients relying on safe blood supply. 

An industry expert sat down to explore the promise of TRODELVY and other ADCs as transformative treatments for a range of malignancies and intractable diseases.

Delve into the intricacies of creating robust cell lines for monoclonal antibody production, as well as process development principles key for achieving therapeutic success.

This poster reviews studies for three mAb drug candidates utilizing a panel of small scale, fast, and predictive tests used to evaluate therapeutic antibodies’ developability.

DFM discussion must be concise and backed by both historical data and up-to-the-minute insights, e.g., discovered through prototyping, test runs, etc.

By partnering with a trusted company that offers expertise in navigating scale up, developers can have confidence in their ability to successfully bring their products to market.

When choosing between protein expression formats such as transient versus stable pools, considerations include speed, cost, titer, and product quality.

Translating drug discoveries into trials remains a complex endeavor. Learn how a CDMO with cutting-edge technologies can facilitate a smooth path from discovery to FIH studies.

Review a CDMO's strategy for overcoming challenges when acquiring new equipment for an Emergency Use Authorization (EUA) project and how leveraging existing resources and collaboration was key.

Partner Week is back this October! From 10/21 through 10/25, hear from CDMOs across Fill/Finish, Large Molecule, Small Molecule, Cell & Gene, and our newest addition: ADC. Bring your questions and requirements, skip the small talk, and get right down to the business of finding the best-fit partner for your short- and longer-term drug development needs. Register for free at this link.

Working with the right CDMO is vital for successful drug lifecycle management. We now serve more than half of the world’s leading companies, sharing their mission to expedite patient access to life-saving biologics.

Examine how a new high-speed aseptic filling line can help bring your product to market with speed and efficiency while ensuring safety and high product quality.

A CDMO with expertise encompassing microbial fermentation, mechanical and chemical cell lysis, product recovery, and downstream purification can support your biomanufacturing needs.

The BD UltraSafe Plus 2.25 mL Passive Needle Guard features an ergonomic design to help support injection comfort and ease of use.