08.10.26 -- From Cell Therapy To Oral Biologics: Trends Shaping Development

Developing a combination drug–delivery product extends far beyond drug development. Pharmaceutical companies must decide whether to use an existing device platform or create a custom solution. While bespoke devices can improve performance and differentiation, they require managing design, manufacturing, assembly, combination product integration, packaging, serialization, release testing, and regulatory compliance. Successfully coordinating these activities is essential before products can enter clinical trials or reach patients in hospitals or home settings. Learn more.

The Pessano, Italy, facility offers 220,000 sq. ft. of end-to-end services, including R&D, formulation development, clinical and commercial manufacturing, packaging, and advanced analytical capabilities.

A principal scientist shares how his team overcame key manufacturing challenges in complex bispecific antibody production, highlighting problem-solving strategies and impressive results in this concise educational video.

A fireside chat explores spray drying basics, oral biologic dosage forms, key formulation hurdles, and analytical testing strategies to ensure drug product quality, safety, performance, and manufacturability.

While visible particles often draw immediate attention, visual inspection alone is insufficient, as subvisible particulate matter can pose equally significant risks to patient safety.

This segment of the Outsourced Pharma Live event, “Beyond Data Packages: De-Risking Tech Transfer To CDMOs,” addresses one of the most common sponsor assumptions in tech transfer: that handing over a batch record and protocol is enough. Darren explains why the real risk often sits in the tacit knowledge behind those documents, including years of process understanding that may never be fully captured in the formal data package. Featuring Darren Dasburg, CEO, Clarus Biologics. 

Explore challenges and solutions in developing novel AAV capsids, focusing on manufacturing complexity, analytical testing, and regulatory considerations for advancing gene therapy effectiveness.