07.20.26 -- STREAM Edition: Are You Really Ready To Transfer?

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.

A fireside chat on how integrated development models reduce risk and accelerate bioconjugate timelines from discovery through GMP manufacturing.

Interested in improving cell viability in biologics manufacturing? See how perfusion processes help maintain healthier cell cultures by continuously removing waste products.

Speed biologics development from DNA to patient using advanced cell line platforms, targeted integration, and data‑driven selection to improve stability, efficiency, and confidence.

Treating Annex 1 as an extension—not a burden—enabled a smooth transition, validating existing contamination control practices and reinforcing established quality standards.

De-risk tech transfer to CDMOs by assessing internal readiness—ensuring CPPs are defined, CQAs are measurable and linked, QC methods are reproducible, and variability drivers are understood.

Overcome adenoviral scale-up challenges with a design-to-scale manufacturing framework that optimizes cell growth, boosts vector productivity, and supports reliable clinical supply.