Sk pharmteco Whitepapers

1. Control Strategies And Method Development For Nitrosamines In APIs And Drug Products 4/15/2025

   Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.

2. CGMP-Validated RCL Assay Used For Release Testing Of Manufactured Viruses, Gene Mediated Cell Therapy Products 3/5/2025

   Ensure the safety and efficacy of lentiviral-based therapies by addressing the risks of replication-competent lentiviruses (RCLs) through advanced monitoring and control strategies.

3. Adapting A rcAAV Assay For Commercial Manufacturing 9/16/2024

   Better understand the intricacies of AAV triple transfection and how advances in vector production and cell line optimization are enhancing gene therapy.