About Us

Wheeler Bio is an innovative contract development and manufacturing organization (CDMO) specializing in the development and cGMP manufacturing of large molecule biologics, including antibody-based therapeutics, bispecific antibodies, fusion proteins, and other complex biologics. Wheeler Bio has pioneered a novel biologics CMC platform, ModularCMC^®. ModularCMC, through its streamlined ICH-aligned technical modules and AI/ML-driven process design, accelerates the translation of biologics from discovery through clinical-stage manufacturing with built-in scalability to support late-stage development and commercial readiness.

ModularCMC streamlines biologics chemistry, manufacturing, and controls (CMC) by creating custom structured, systematic work packages that de-risk antibody and other protein production at any scale. By establishing clear milestone checkpoints, ModularCMC enables developers to create a program appropriate to their development stage, thereby reducing the risk of failure, supporting funding efforts, and ultimately shortening time-to-clinic. This integrated approach ensures a right-sized CMC program for any development stage: in vitro assessments, GLP preclinical tox studies, or full clinical cGMP drug substance and drug product manufacturing. ModularCMC creates an efficient, risk-mitigated route to generate high-quality biologics supported by a comprehensive CTD Module 3 for IND-enabling, first-in-human clinical evaluation in an ICH-aligned regulatory jurisdiction.

Wheeler Bio’s High-Science, High-Touch philosophy combines advanced biologics development and manufacturing technologies with an experience-led scientific leadership fostering a culture that emphasizes transparency, scientific rigor, CMC and regulatory preparation, and scientific collaboration. The company’s mission is to accelerate the advancement of antibody-based therapeutics, including monoclonal antibodies (mAbs), bispecific antibodies (bsAbs), fusion proteins, and other biologics into the clinic. This enables drug development partners to bring life-changing therapies to patients faster, more efficiently, and with greater biosecurity.