Bringing a new biologic therapy to patients is a complex process. Timelines are tight, regulatory expectations are strict, and ensuring the viral safety of your product is non-negotiable. Whether you are filing your first Investigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) application, or navigating commercial production, the demand for accurate, compliant, and timely viral clearance (VC) studies creates significant pressure. You need a partner you can trust to deliver dependable results.
The Eurofins BioPharma Product Testing (BPT) network of laboratories has built a reputation for excellence in viral clearance testing, supporting biopharmaceutical companies at every stage of development. Our laboratories are staffed by highly trained scientists, and our services are underpinned by more than 80 years of combined experience in viral safety and clearance studies.
With strategically located facilities, we offer cost-efficiency and speed without compromising quality. Our viral clearance studies are fully GLP / cGMP-compliant, employing both standard and tailored models to meet your specific needs.
Whether you require virus spiking, downstream processing, or validation of virus removal steps, our experts will design and conduct comprehensive studies to ensure your viral clearance goals are met.
Recognising the significant costs and complexity associated with viral clearance, we design each study to be as efficient and informative as possible, empowering you to move forward with confidence. Our in-depth regulatory guidance, coupled with our vast experience, ensures your studies will align with global regulatory expectations for patient safety.
For early-phase clients, particularly those approaching IND/IMPD submissions, we offer expert guidance in navigating the unfamiliar terrain of viral clearance requirements. Our specialists are adept at tailoring studies to the scale and scope of early development programmes, offering reassurance when it matters most.
To choose the Eurofins BPT network of laboratories is to choose the path to precision, reliability, compliance, and success.
