Your Partner for Process Development and cGMP Manufacturing
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Goodwin Biotechnology Will Design & Execute Your Process Development & Manufacturing Strategy

Whether you have already developed a conjugation process and simply require a technology transfer or need development of a new conjugation process, Goodwin Biotechnology will partner with you to develop and/or optimize your Cytotoxic Antibody Drug Conjugate (CADC) using a risk-based Quality by Design (QbD) approach. 

Selection of an appropriate linker is important, and Goodwin Biotechnology demonstrates tremendous flexibility in this regard.  We can:
  • Utilize your proprietary linker, or
  • Employ our proprietary and license-free Linker Technologies, including
    • Non-cleavable, thioether-based SteadFastTM Linker Technology, or
    • Cleavable, disulfide- or hydrazone-based FlexReleaseTM Linker Technology
  • Collaborate with our partners to design and synthesize novel, cleavable linkers based on peptide or other appropriate linkages. 
For more information on our unique SteadFast™ or FlexRelease™ Linker Technologies, please fill out the form below.

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.
For more information on our Cytotoxic Antibody Drug Conjugate (CADCs) services please fill in the form below.