US viral clearance
Our Lancaster, PA site supports both R&D and cGMP work. It is equipped with four separate suites dedicated to the execution of viral clearance studies to ensure privacy and confidentiality. Our offering includes:
Viral clearance expertise
Driving compliance and confidence in viral safety
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.
Recognizing 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 programs, 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.
Viral clearance offering
Negative-pressure, HEPA-filtered lab suites including an anteroom and private office for client’s use
GE ÄKTA chromatography units (Pure 25 and Avant 150 models available)
Biological Safety Cabinets equipped with vacuum line
Fully equipped BSL-2 laboratory space with expert staff trained to handle viruses and cell culture
Balances, conductivity and pH meters, UV/Vis spectrophotometers, plus other basic lab equipment
Validated, real-time infectivity result assessments on 6-well plate with options for a large volume method for retroviral testing, as well as validated qPCR detection methods
Characterized viral stocks with validated titers of ≥10<sup>7</sup> PFU/mL to support animal and human-derived products, including highly purified stocks ideal for viral filtration needs
Viral clearance service models
To best meet all client needs, Eurofins BPT offers two models of service.
Traditional service model: provides clients with dedicated office and meeting spaces during the study; grants access to the above-mentioned suites and use of the ÄKTA® systems for performance of purification steps by their staff.
In addition to spiking, sampling, and end point testing procedures, Eurofins BPT personnel perform inactivation and filtration steps, or also host outside filtration vendors.
Full service model: Eurofins BPT viral clearance experts perform all process steps
Includes technology transfer on the scaled-down process and purification steps. We provide tailored batch record documentation developed in collaboration with the client for all processes.
Both service models:
Deliver Certificates of Analysis or final report for each process step performed, as well as a summary report. Regulatory support through post-study applications is available.
Our client-centric approach to viral clearance