12.01.25 -- AI Is Not The CMC Revolution You're Looking For, And That's OK

Discover the potential of T1 cell-derived nanoparticles (CDNPs) to accelerate T-cell activation. See how CDNPs’ unique mechanism of mimicking physiological immune stimulation positions them for broad use.

Uncover why leveraging strong scientific expertise and comprehensive testing techniques will be vital in expediting development and upholding the integrity of these life-saving treatments.

Rapidly shifting modalities require broad CDMO expertise and capacity, and commercializing recombinant vector vaccines requires a skill set that differs from protein or peptide based approaches.

Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.

Integrated analytical capabilities within a CDMO are increasingly preferred to overcome challenges associated with outsourcing analysis in biopharma development and manufacturing.

This study aims to explore the kinetics of capsid formation and impurity profiles over time, offering insights that can inform future process improvements.

Gain valuable insights into the critical role of apheresis in sourcing high-quality cellular material for therapies.

Vector redesign and regulatory hurdles can add years to development timelines. A single-partner approach helps streamline the process, secures timelines, and ensures smooth tech transfer to the clinic.

Examine the secrets behind successes in commercializing and producing commercial cell and gene therapies, including establishing standards of every day, manufacturing operational excellence.

One family managed to combine resources and people to get an investigational gene replacement therapy manufactured and approved by the FDA so their daughter could be dosed just 14 months from her diagnosis.

Quality is the foundation of leadership and operations, ensuring collaboration and strategic focus to deliver safe, effective cell therapies without compromising patient safety or regulatory standards.

Scaling up viral vector production can be challenging, and ensuring consistent titers and activity requires careful optimization and technical expertise.