Putting Pressure On CDMOs With Herman Bozenhardt

Progress in cell and gene therapy hinges on aligning therapeutic design with scalable, efficient manufacturing to improve accessibility, reliability, and real‑world feasibility across advanced modalities.

A new regulatory chapter requires holistic, real‑world testing of injectable systems, mandating full‑system validation with actual drug products and prioritizing patient‑centric performance and safety.

Explore current and emerging technologies to optimize mRNA manufacturing, especially when considering commercial production and the validation of processes in a cGMP environment.

The top five common cell line development pitfalls — scalability, stability, complexity, analytics, and tech transfer — can be avoided with experienced partners and integrated, predictive strategies.

A development leader highlights supply‑chain resilience, cost‑efficient large‑scale manufacturing, proven tech‑transfer success, and long‑term commitment to supporting clients through reliable scale‑up.

Rapid analytical testing turnaround is essential to maintaining development timelines, meeting clinical milestones, and in commercial manufacturing, providing reliable drug supply to patients.

A GMP‑ready cell bank requires controlled stability, sterility, genetic integrity, and complete documentation to ensure consistent, safe biologic production and meet regulatory expectations.

Learn the strategy for achieving sustainable growth through organizational transformation. Systematic digitization and right-sized automation set the stage for next-level operational excellence.

For complex projects involving oral solid dosage (OSD) and sterile drug products, selecting the ideal CDMO can play a pivotal role in determining the success of a drug candidate.

Viral‑clearance studies need phase‑appropriate design, strong virus stocks, modality‑specific risk assessment, and alignment with evolving regulations for reliable safety outcomes.