Simplifying bioconjugate development and manufacture
Our full service offering for bioconjugates provides you with tailored drug intermediate manufacturing, process and analytical development, formulation development, drug substance manufacturing and drug product development and manufacturing services, all under one quality system supported by global regulatory services and writing support. Our scientists and engineers bring a decade of development experience across a broad spectrum of both platform and novel conjugation technologies. We also understand your need to pace and manage investments in the different phases of the development cycle and offer flexible business models to help meet your specific program needs.
Our experience spans a broad range of bioconjugation technologies, including ADCs, radio-immunoconjugates (mAb conjugated to chelating agents), vaccines (haptens conjugated to carrier proteins), PEGylation and cross-linking, antibodies conjugated to nanoparticles (TNPs) and non-cytotoxic drugs (including peptides). Our services are geared to enable the commercialization of your drug candidate and we have a successful track record of marketed bioconjugates.
Our highly experienced regulatory affairs team has the capability to support your project at all stages of the development lifecycle from concept to commercialization. We were among the first CDMOs to support commercialization of bioconjugates. This experience allows us to advise you on developing your regulatory and submission strategies, preparing you for success.