No bio/pharmaceutical product can be manufactured without first establishing the identity, purity and quality of its starting materials to ensure the product is suitable for its intended use. When this critical step in the bio/pharmaceutical manufacturing process is performed successfully, costly production problems and delays can be avoided. Eurofins BioPharma Product Testings’ North America sites offer a comprehensive GMP raw materials testing package supporting compendial & non-compendial analysis, containers testing, characterization testing, metals testing, mycoplasma testing and more. Our extensive…

There are currently over 250 antibody drug conjugates (ADCs) in global clinical trials. This historically high number says more, perhaps, about drug developers’ belief in these novel, complex modalities than it does about how difficult or expensive it can be to bring them into the clinic. Challenges faced in the process of discovering, engineering, and developing ADCs start with identifying a highly specific antibody with the necessary binding affinity to the disease target, and then coupling the antibody with the…