12.15.25 -- STREAM Edition: Ensuring Quality And Regulatory Compliance In Outsourced Manufacturing

Discover how developability assessments are crucial for identifying biologic candidates that are both effective and manufacturable, thereby reducing risks and improving the chances of clinical success.

Tom Sellig, CEO of Adare, discusses the ongoing relevance of small molecules, oral solid dose development, trends like GLP-1, and innovations like 3D printing in pharmaceuticals.

Here, we review the draft guidance and the importance of component selection in establishing a risk-based approach, as well as the role of the NovaPure product line in component selection.

This segment of the Outsourced Pharma Live event, “Small Molecule Outsourcing: Getting Timelines, Tech Transfer and Analytics Right,” outlines how sponsors can ensure that a CDMO’s quality systems and analytical outputs meet regulatory expectations.

Gain access to specialized sterile injectable manufacturing. Expertise covers vials and modern pre-filled syringe capacity, supported by single-use systems and decades of proven quality for global markets.

Explore considerations for phase-appropriate AAV characterization and release activities from pre-clinical to late-phase products. Review validation challenges and paths for maturation of analytics.