bioconjugate services

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.

Phase appropriate services

Our services and equipment are tailored appropriately to pace your investments from pre-clinical to commercialization. We collaborate closely with you to align our services with your needs. We focus on your next milestone with your ultimate goal in mind.

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Our GS Xceed® Gene Expression System has options to engineer and express conjugation-competent antibodies. Applications include antibody-drug conjugates (ADCs), half-life extension and imaging.

Unlike other contract development and manufacturing organizations (CDMOs), we are in the unique position to offer complete development and manufacturing services from both mammalian cell culture and advanced chemical synthesis for the production of Antibody-Drug Conjugates (ADCs). From process development to manufacturing scale-up, we are proud to offer more ways than ever to deliver your product.