Lonza, a CDMO, and Integral Molecular, which focuses on discovering and characterizing antibodies against membrane proteins, report that they will 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 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, according to Yvette Stallwood, head of early development services, which utilizes 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.
“Early immunogenicity de-risking significantly increases chances of the future success of therapies as they progress through the development pathway,” notes Stallwood. “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.”
“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,” adds Benjamin Doranz, CEO and co-founder of Integral Molecular, who points out that 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.
The Lonza services will be provided under an agreement with Lonza, and the Integral Molecular services will be provided under an agreement with Integral Molecular.
