03.13.26 -- Field Notes: Reducing Risk At Kivi Bio's Interchangeability Conference

Cell therapies are revolutionizing cancer care, but their complex manufacturing and high costs bar access for many patients. Automation is emerging as an efficacious solution to reach patients in need.

Explore freeze and thaw technology that is being used to prevent alterations in the drug substance through the minimization of protein aggregation.

Discover how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

Scale-up often introduces shear stress and process variability. Learn how low-shear, single-use technology stabilizes media exchange and harvest, ensuring consistent cell quality and performance.

Examine how particle levels remained stable during 24 hours of high-speed mixing, even under extreme temperatures, confirming a system’s suitability for final fill and other particulate-sensitive applications.

Find out how early stable CHO expression data reveals manufacturability issues in complex antibodies that transient screening misses, with case studies showing how this changes lead selection.

Discover how our optimized CHO K1 cell lines achieved up to an 80% increase in titer while maintaining product quality through molecule-specific process development strategies.

Listen to how digital collaboration can streamline technology transfer and reduce errors, as well as how centralized process knowledge supports efficiency and scalability across development.

Explore experimental approaches to extracellular protein secretion that streamline recovery and improve product quality. See proof-of-principle data across multiple protein types and molecular weights.

Precise control over shaker parameters is vital in bioprocessing. Read how to tailor cultivation environments, maximizing efficiency and reproducibility for diverse cell types effectively.

Successfully bring your CGT products to market by joining industry experts as they discuss challenges in CGT process development.

Gain insights that can support your next steps, whether advancing to a new clinical phase, constructing a new facility, or fine-tuning an existing process to keep pace with market shifts.

The heterogeneity of a biologic product has implications for the final therapy's safety and efficacy. Learn about the challenges associated with charged variants, including mAbs and fusion proteins.

See why template sequence characteristics are relevant for cGMP manufacturing of high-quality mRNA and consider insights on how to develop a scalable, robust, and economically viable process.

Explore findings from a study testing single-use bags under rigorous shipping conditions, demonstrating their suitability for transporting various liquid volumes while preserving their integrity.

Discover why cryopreservation studies are so critical and how biopharmaceutical manufacturers can more easily navigate the complexities of this process.

While barrier films in bags can be useful for cold chain applications, they do not fully protect against gas ingress and ignore other sources of permeability.