Development of a Standardized, Kit-Based Approach for Selective and Reproducible Sample Preparation and Extraction for Therapeutic Oligonucleotides from Biological Matrices
This app note reviews the development of the OligoWorks SPE Microplate Kit and detergent-free protocol for oligonucleotide bioanalysis and demonstrates performance across a broad range of chemically diverse oligonucleotides, including GalNAc and lipid-conjugated species. The analytical testing and screening work to optimize the protocol for high recovery and low matrix effects is discussed in detail and LC-MS data is presented for spiked plasma and urine samples showing excellent inter and intra-kit, day-to-day and user-to-user reproducibility (RSDs ≤15%).
GMP Validated Next Generation Sequencing Services: Viral Safety Testing & Genetic Characterization
March 26th 2025This brochure will expand on our NGS testing services to biopharmaceutical and biotech companies, including viral contamination testing and genetic characterization of cell lines, bulk harvests, virus seeds, and raw materials used for production of biologics including cell and gene therapy products.
Develop Potency Assays Early for ATMP Success
March 26th 2025Early potency assay development and MOA understanding are critical for ATMP success. Delays can increase costs and risk failure, but recent advances highlight the need for timely, validated approaches to ensure regulatory and commercial success.
Engage with Industry Leaders on Viral Clearance & Viral Safety at 2025 Summit
March 26th 2025Join on June 3-4 in Cologne, Germany to gain insights from leading regulatory authorities, academics, and industry practitioners who define how biologics, vaccines, and advanced therapeutic medicinal products (ATMPs) are evaluated. Discover the latest technologies, learn best practices, and understand how to design an efficient manufacturing process.
