07.17.25 -- The FDA Was Darned Near Perfect, Right?

Roger Cone, Ph.D. joins Business of Biotech to share how his academic discovery of obesity-related brain receptors led to founding Courage Therapeutics. He discusses developing obesity drugs with fewer side effects than GLP-1s and highlights the power of combining scientific and business leadership. Supported by Ecolab Life Sciences.

Dive into a summary of stability considerations and process examples for recombinant proteins, mAbs, gene therapy, and subunit vaccines.

Optimizing recombinant expression and scalable purification strategies can help accelerate the production of challenging proteins, enabling successful program initiation and advancing pipelines.

With increased pressure on CMC development to support shortened BLA submission timelines, mass spectrometry (MS) can be leveraged to accelerate and de-risk product and process development.

In biologics and cell and gene therapy (CGT), selecting and managing a CDMO has become a strategic imperative. Unfortunately, traditional approaches to external partners can fall short. But now AI is reshaping this landscape. Analysis from an Outsourced Pharma Board member.

Partnering with an experienced sterile CMO is essential for small-batch injectables, requiring clear communication, quality alignment, and regulatory compliance to ensure manufacturing success.

Explore how a fully integrated, U.S.-based supply chain strategy can help you navigate potential tariff risks, reduce complexity, and strengthen resilience in pharmaceutical development.

Review this end-to-end workflow, including First-to-Human antibody development strategies, the use of the PentaMice® platform for targeted immunization, and the precision of single B cell screening.

Understand the challenges in developing and manufacturing these formulations to ensure a successful partnership with a CDMO.

Observe research that demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

Examine how a comprehensive range of services, from drug product development and manufacturing to commercial packaging and global launch, can help you deliver therapies in a time-efficient manner.

The future of conjugation and PEGylation in biologics is promising, with advancements focused on enhancing drug efficacy and reducing immunogenicity. Understand the key focus for these proteins.

Discover our fill line capabilities, including vial and syringe handling, as well as an immersive tour of our drug product filling facility in Denmark. 

Learn how we excel in the development and manufacturing of diverse dosage forms for both clinical and commercial applications, driven by a culture of innovation and commitment to quality.

Take a virtual tour of our GMP-certified facility, where we uphold the highest standards for manufacturing, leveraging our expanded capabilities in large molecule development.

Join Dr. Srinivasan Shanmugam in this webinar to learn key strategies for selecting the right CDMO, reducing costs, accelerating timelines, and ensuring product success.