25 Apr 2022
Lonza Early Development Services and Integral Molecular to Offer Complementary Expertise to Enhance Early De-risking of Biotherapeutics
  • The respective expertise of Lonza and Integral Molecular will benefit drug developers in the assessment of the risk for off-target binding and activation
  • The complementary offerings provide benefit in early de-risking and safety assessment of biologic drug candidates, thereby improving the likelihood of success in clinical development

Basel, Switzerland and Philadelphia, USA, 25 April 2022 – Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, and Integral Molecular, an industry leader in discovering and characterizing antibodies against membrane proteins, announced today a strategy to offer complementary expertise to their respective customers to better assess the risks of off-target binding of biologic drug candidates.

Unwanted immunogenicity can have severe consequences for patients and jeopardize drug development programs. Therefore, de-risking therapeutics by assessing their immunogenicity potential early is not only a regulatory requirement to support First in Human studies but also an essential tool that can significantly improve a drug candidate's chances of success further down the development and manufacturing pathway. Immunosafety risk assessments help to ensure that the target molecule has no unwanted immunogenicity, immunotoxicity, or cross-reactivity potential.

The respective expertise can benefit drug developers in the early de-risking of their drug candidates by allowing Lonza and Integral Molecular to complement each other's offerings in the assessment of the potential for off-target binding and activation. Lonza's Early Development Services focuses on cell-based assays to evaluate the activity of biologic therapies upon binding. Integral Molecular de-risks therapeutic molecules by detecting off-target binding liabilities using their Membrane Proteome Array platform.

Yvette Stallwood, Head of Early Development Services, Lonza, commented: "Early immunogenicity de-risking significantly increases chances of the future success of therapies as they progress through the development pathway. Lonza's 14 years of expertise in in silico and in vitro immunogenicity and immunotoxicity assessments complements Integral Molecular's valuable insights into off-target binding using their Membrane Proteome Array.”

Benjamin Doranz, CEO and co-founder, Integral Molecular, added: "We are pleased to offer complementary expertise to Lonza’s cell-based assay experience for preclinical safety profiling of biologics, thereby offering drug developers a more complete evaluation methodology to select the optimal candidate to move forward to IND filing.”

The complementary expertise of the companies will cover the full spectrum of in vitro immunosafety testing and allow customers to save time and resources by identifying and mitigating potential clinical risks earlier on.

Lonza and Integral Molecular recently co-presented a webinar about the challenges of assessing off-target binding and activity when developing biotherapeutics. To learn more about our respective expertise, you can access the webinar recording Confidently Assess Potential Unintended Binding and Activity of Biotherapeutics.