Analytical Development
Orthogonal approaches to product characterization support better understanding of an asset's performance, safety, and the manufacturing processes for Drug Substance (DS) and Drug Product (DP).
Raw Material Testing
Use of animal-derived products in biologics development or manufacturing creates an inherent risk of adventitious agent contamination in historic cell banks, seed viruses, and finished products. Our wide range of testing services are aimed at ensuring the quality and purity of raw materials.
Cell and Viral Bank Testing
Cell and virus bank is the starting material for the biologics manufacturing process. Extensive characterization at this stage is important to ensure viral safety and genetic stability.
Viral Clearance Testing
Our viral clearance studies are designed by experts in global regulatory requirements, downstream processing, and virology. Having performed more than 17,300 viral clearance studies in our U.S., UK, China, and Singapore facilities, biomanufacturers trust in us to minimize risk as they bring their products to market.
Rapid Viral Detection
We have a history of shaping the biosafety testing industry with new technologies and paradigms. Our team of scientific, regulatory, and quality assurance experts lead the development and selection of rapid viral detection methods to accelerate biosafety testing.
Bulk Harvest Release Testing
Whether preparing for clinic or manufacturing a life-saving therapeutic biologic, it is critical that our clients protect their investment with GMP-compliant release testing.
Drug Product Release Testing
To help our clients demonstrate compliance with regulatory guidelines prior to releasing their biologics into global pharmaceutical markets, we offer a wide range of GMP assays and testing services for final product packages.