09.10.25 -- Barriers, Breakthroughs, And Building Access In Pediatric CGTs With Bambi Grilley, Ph.D.

Mycoplasma contamination poses a significant risk to biopharmaceutical products and patient safety. See how implementing a rapid NAT-based testing method can enhance efficiency and quality control.

Gene therapy manufacturing demands a careful balance between contamination control and efficiency. A strategic approach to “critical aseptic” designation is essential to meet evolving regulatory challenges.

Medical writers completing gene therapy submissions require strategic placement, justification, and cross-referencing to fit unconventional data within a standard template.

Efficient quality control of therapeutic oligonucleotides is crucial. Explore advanced methods combining HPLC-UV and mass spectrometry for precise impurity quantification and mass confirmation.

This presentation emphasizes the significance of minimizing particulate contamination in pharmaceutical and biopharmaceutical products produced through the use of single-use systems.

By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs.

Building the right cleanroom involves critical early decisions. Learn about a methodical framework ensuring flexibility, compliance, and operational readiness from initial concept through delivery.