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.”
About the Complementary Offerings
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.
About Lonza Early Development Services
Lonza Early Development Services offers a comprehensive suite of in silico and in vitro early development services to assist pharmaceutical and biotech companies in de-risking and optimizing their late candidate selection and lead candidate development process. The group, based in Cambridge (UK), also provides early, phase-appropriate non-GMP protein expression via Lonza’s Light PathTM Discovery platform.
Lonza is a preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry.
Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 16,000 full-time employees, we comprise high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 5.4 billion with a CORE EBITDA of CHF 1.7 billion in Full-Year 2021. Find out more at www.lonza.com.
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About Integral Molecular
Integral Molecular is an industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular’s technologies have been integrated into the drug discovery pipelines of over 400 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.
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