Eurofins generates unique integrated capabilities offer to support clients’ biologics advancements

Capucine Henquell, Business Manager, Eurofins Optimed, capucine.henquell@ba.eurofinseu.com

The development of biologics, including therapeutic antibodies such as Antibody Drug Conjugates (ADC), bispecific antibodies, recombinant proteins, conjugates, and emerging biotherapeutic platforms, requires end-to-end expertise covering advanced bioanalytical characterisation and high-quality bioanalysis during drug development, as well as GMP controls during the manufacturing process. To meet rising expectations for speed, scientific precision, and seamless coordination across R&D programmes, Eurofins offers an integrated solution built on the combined strengths of three complementary entities: Eurofins Optimed, a clinical centre and CRO; Eurofins ADME Bioanalyses, a leading expert in bioanalysis, pharmacokinetics, and immunogenicity; and Eurofins BPT Biologics, specialised in GMP testing in biologics manufacturing. Together, they create a unique technical continuum that supports biotech and pharmaceutical developers from preclinical GLP and early clinical trials, to late phase clinical GCLP stages. In parallel, they deliver controlled, reproducible production to help clients ensure their biologic drug is safe, pure, potent, and consistently produced.

At Eurofins Optimed, clients benefit from more than 35 years of experience in managing clinical trials, with a state-of-the art Phase I unit, or via a network of clinical sites across Europe and America. Their expertise guides you from protocol design through the full translational pathway, from preclinical to clinical trials: supporting go/no go decisions, starting-dose selection, tailored dose-escalation strategies based on PK profiles, and the choice of endpoints and target population. The Eurofins team has the clinical expertise to manage clients’ biologics, particularly for their first administration in humans (FIM), while considering their specific characteristics and requirements, such as compliance with the cold chain, specific pharmacy preparations, and administrations. Understanding specific medical constraints and risks, its medical team is trained and available 24 hours a day, 7 days a week.

Eurofins ADME Bioanalyses delivers industry leading expertise in the development and validation of bioanalytical methods, therapeutic antibody quantification, pharmacokinetic and immunogenicity assessments, and biomarker analysis. Harnessing state-of-the-art platforms, including immunoassays (ELISA, ECL, cell-based assays), LC MS/MS, and advanced analytical technologies such as immunopurification and antibody characterisation, our teams generate highly sensitive, reliable, and fully regulatory aligned data. Compliant with FDA, EMA, and ICH guidelines, we ensure that every dataset empowers confident, timely decision making across all stages of drug development.

To complete the service offer, Eurofins BPT Biologics brings full expertise of multidisciplinary Quality Control (QC) in the manufacturing of biomolecules, from process development and optimisation to GMP compliant or preclinical/clinical stage adapted production. Continuous quality controls throughout manufacturing ensure batch reliability, reproducibility, and regulatory alignment. This strong industrial capability provides developers with well characterised materials ready for subsequent analytical and regulatory evaluation.

The integration of manufacturing, preclinical, and clinical expertise, including bioanalysis conducted within the Eurofins network of laboratories, generates substantial added value for biologics developers. Firstly, the end-to-end continuity between production and analyses minimises logistical risks, avoids additional delays, and reduces variability between batches. Early collaboration between manufacturing and analytical teams enables optimised method development, faster study initiation, and greater scientific consistency throughout the programme. Clients also benefit from streamlined project management through a single point of contact, offering greater visibility, simplified coordination, and improved responsiveness.

By combining the industrial strength of Eurofins Optimed, Eurofins ADME Bioanalyses, and Eurofins BPT Biologics, Eurofins delivers comprehensive, agile, and strategic solutions designed to secure and accelerate biologics development. This integrated approach responds to the increasingly complex demands of today’s biopharmaceutical landscape and represents a significant advantage for organisations seeking reliable,
high performance partners to guide their biotherapeutic programmes toward success. For more information, visit: www.eurofins-optimed.fr/; www.eurofins.com/biopharma-services/adme/; and www.eurofins.fr/biopharma-product-testing/