12.04.25 -- How To Improve Sponsor–CMO Collaboration Around Digital Deviations

Dive into the scope of <382> for pharmaceutical closures and the regulatory landscape, which includes new required tests, instrumentation for compliance, and recommendations on implementation.

To overcome challenges in oligonucleotide LC/MS bioanalysis, consider optimizing probe design by evaluating alternative chemistries like PNA for improved recovery and chromatographic performance.

Next-generation sequencing (NGS) accelerates therapy development by enabling rapid, cost-effective DNA/RNA analysis crucial for cell and gene therapies, process optimization, and impurity detection.

Explore how intensified upstream processing enriches full AAV capsids, reduces impurities, and lowers manufacturing costs. Learn how extended culture duration drives better outcomes.

Discover how rigorously controlled, aseptic precision fill/finish processes ensure the safety, sterility, and success of cutting-edge viral vector therapies as they move from production to patients.

With experience in managing assay transfers across diverse sources and development stages, we have identified five factors that can significantly impact the success of potency assay transfers.

See how this advanced SKPT-HEK293 4G9 was able to provide a robust, CGMP-ready solution for efficient viral vector production, supporting a range of AAV serotypes and CAR-T Lenti-viral vectors for manufacturing.

Learn about the development of a serum-free suspension MDCK cell line that serves as an optimal platform for isolating human influenza viruses from clinical samples and producing vaccines at scale.

Effectively applying compendial testing to cell and gene therapy products requires strategic test ordering and specialized micro-equipment to manage limited volume and accelerate turnaround time.

Standardized, well-characterized plasmids and streamlined platform processes can significantly accelerate viral vector development, improve consistency, and support scalable, high-quality gene therapy manufacturing.