Goodwin Biotechnology leverages over 10 years of bioconjugation experience and expertise which complements our more than 20-year history in the development and manufacturing of mammalian cell culture-derived monoclonal antibodies, recombinant proteins and vaccines, making us one of the most experienced and stable contract manufacturing organizations (CMOs) in the world. Moreover, our global customer base which includes clients from North America, Europe as well as Asia, consists of companies ranging from academic institutions and biotechnology startup firms to large, established, multinational biopharmaceutical companies. Recognizing the challenges of manufacturing complex molecules such as CADCs, Goodwin Biotechnology will help to formulate a strategic approach to your project with an emphasis on critical development, manufacturing, quality, regulatory and characterization considerations.
Selection of an appropriate linker is important, and Goodwin Biotechnology demonstrates tremendous flexibility in this regard. We can:
Moreover, selection of an appropriate cytotoxic payload to which the target cancer cell demonstrates susceptibility is critical, and Goodwin Biotechnology will help to evaluate a payload of the appropriate potency and specificity under the Safebridge or Merck classification systems (e.g., protein toxin, cytotoxic peptide or small molecule cancer drug).
Goodwin Biotechnology can work with cytotoxic payloads up to Safebridge Level 3 within our own facilities (e.g., doxorubicin or methotrexate); however, for ADCs utilizing highly potent cytotoxic payloads (e.g., maytansine, auristatin, DM4, or tubulysin) requiring a Safebridge level 4 / Merck level 5 facility, GBI has collaborated with Coldstream Laboratories where we seamlessly execute all conjugation processes within Coldstream’s high-containment facilities, from proof-of-concept through late-stage clinical trials and large-scale cGMP manufacturing or commercial products.
Rest assured, whether we work onsite at GBI or offsite at our partner’s facility, we will develop at the earliest stages a scalable, GMP-compliant, economical and efficient process that is designed to manufacture your CADC product in an expedient manner and meet all appropriate quality requirements relative to safety, purity, identity, potency and immunogenicity.
Further, at an early stage during development, Goodwin Biotechnology will perform product pre-formulation with limited stability studies to determine the appropriate buffer pH, conductivity, excipients, and storage temperatures that confer long-term product stability. In addition to pre-formulation development, our collaborative partner, Coldstream Laboratories, can develop lyophilized formulations that are based on robust and cost-efficient processes. Their rapid-response formulation team has experience in screening effective combinations of solvents (both aqueous and non-aqueous), buffers, bulking agents, and lyo/cryo-protectants. This experience leads to a robust final product that has low residual moisture/solvent, forms a solid and attractive cake, reconstitutes readily and completely, and resists physical and chemical degradation.
Further, Coldstream Laboratories offers clinical and commercial formulation development as well as ISO 5-compliant liquid and lyophilized Fill & Finish in a variety of container / closure systems ranging from tens to thousands of vials depending on your needs.
Examples of our Quality and Regulatory expertise