Bioconjugate process development
With our unique combination of knowledge and experience, we provide end-to-end support for your project, covering every stage from initial process development to GMP manufacturing of high-quality bioconjugates.
Expert CDMO for manufacturing of bioconjugates & ADC
Bioconjugation involves linking molecules together with at least one of the reactants being a biomolecule, often an antibody, protein, or oligonucleotide. The successful and safe manufacturing of these complex drugs requires an experienced team and dedicated facilities when cytotoxic compounds are involved.
Our team’s proficiency extends to supporting the development, optimisation, and scale-up of a variety of bioconjugation processes.
Offering both mammalian and microbial manufacturing for the production of the biologics intermediates, GTP Bioways can manufacture a variety of bioconjugates, including but not limited to antibody-drug conjugates (ADC), antibody fragment-drug conjugates (ScFvDC), antibody-oligonucleotide conjugates (AOC) and other protein- and peptide-drug conjugates.
Comprehensive process development services for bioconjugates and ADC
Our seasoned team offers a comprehensive range of process development services for antibody-drug conjugates (ADCs) and other drug conjugates:
- Our team is well-versed in using various conjugation technologies, including, but not limited to, maleimide-, NHS-ester-, oxime-, enzyme-assisted- and glycosylation-based-conjugations
- Our team has extensive expertise in site-specific conjugation technologies (DAR 2 to DAR 8) and in conjugating diverse linker-payload combinations, including cytotoxins like auristatin, maytansine, camptothecin, and anthracyclines, as well as non-toxic functionalities such as PEG, oligonucleotides, kinase inhibitors, and immunomodulators.
- Additionally, our downstream process development team has developed a strong expertise in developing purification processes for a wide range of bioconjugates, employing purification methods like UF/DF and column chromatography (IEX, HIC, protein A).
Streamline your ADC production with our comprehensive development & manufacturing services
With our unmatched expertise and capabilities, we seamlessly cover every stage of your antibody drug conjugate project, from antibody intermediate production to bioconjugation and GMP manufacturing of drug substance and drug product.
Supporting every step of your pre-clinical and clinical development
Beyond bioconjugation development, we offer a comprehensive range of solutions to provide support through every stage of your bioconjugate CMC journey.
- Development, optimisation, and manufacturing services for drug substances derived from both mammalian and microbial hosts. This includes expertise and capabilities in all aspects, from initial cell line/strain development to large-scale cGMP manufacturing.
- Manufacturing of materials for toxicology studies, ensuring the availability of toxicology materials that meet the regulatory standards for preclinical assessments.
- Formulation development for both liquid and lyophilised products: Our formulation experts collaborate closely with you to develop optimal formulations that enhance stability, efficacy, and ease of administration.
- Comprehensive analytical development to characterise protein/mAb intermediates and bioconjugates throughout the preclinical and clinical stages.
- Regulatory consulting and assistance in writing relevant sections of INDs to ensure compliance with regulatory requirements
Unlock the full potential of your bioconjugate project with our unparalleled combination of knowledge and experience in bioconjugation development and cGMP manufacturing.
Connect with our team.
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