Glycan analysis provides key information on critical quality attributes that could affect stability, safety and efficacy of a protein therapeutic. Specific needs for understanding the glycosylation profiles change throughout the drug development process, but the requirement for high-resolution glycan information remains the same and is essential to help ensure product quality.
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.