Viral Clearance Laboratories and Facility
Background
- Founded in 1994 as Analysis GmbH
- Acquired by NewLab BioQuality in 2005
- The viral clearance laboratory joined Charles River in 2008
- The lab shifted to a custom-built facility in 2010, and underwent extensive expansions in 2016, 2022, and 2026
- Harmonized with our viral clearance site in Wayne, Pennsylvania
Laboratories and Facilities
- Total footprint: 2,875 m2/30,946 ft2
- Total lab space: 1,228m2/13,218 ft2 (including 200m2 of newly added space in 2026)
- Extensive site security, confidentiality, and safety measures
- Good Laboratory Practice (GLP) compliant archive
Laboratory Features Overview
- Dedicated client labs and guest offices
- Biosafety Level 3** for handling of biological agents (including HIV)
- Biosafety Level 2 for handling of GMOs
- Dedicated cell culture suite for readily available cell culture stocks
- State-of-the-art laboratory equipment includes:
- Temperature and pressure monitoring
- CO2 and N2 gas, and pressurized air
- Cooling and heating incubators (for processes performed at -10 to +60 °C)
- Chiller range from (-10 °C) to (+60 °C)
- Cold rooms (for processes performed at +2 to +15 °C)
- Cryogenic and thermostatic water baths (for processes performed at -55 to +200 °C)
- Fully qualified and validated ÄKTA Pure systems
- Lyophilizers
- Vacuum drying chamber (if desired for flammable solvents)
- Biosafety cabinets class II
- Chemical fume hood (if desired with HEPA Filter)
- Equipment for all common virus retentive filters
- Ultracentrifuges and classical centrifuges (various sizes)
- Photometers, conductivity meters, pH meters
Service Areas
- Selection of process steps
- Selection of high-titer viruses
- Optimization of the design of viral clearance studies
- Regulatory consultation for study planning (Europe, US, Japan)
- Referral for risk assessment consultations
- Accompaniment for agency visits (at the agency or during audits)
- Support for downscaling of manufacturing process steps
- Performance of all downscaled process steps (including chromatography)
- Interpretation of results and support with troubleshooting leveraging an extensive database of over 13,000 process runs
Study Types
- Multi-spike studies
- Gamma irradiation studies
- Multi-site studies
- Viral clearance analytics of samples generated at the client’s site with Charles River virus stocks (if virus handling authorization is granted)
Client Services
- Comprehensive and flexible reporting
- Seminars and training at client sites
- Specific arrangements for long-term agreements
- Dedicated project management and study directors to ensure smooth communications and on-time delivery of projects
Product Experience
- Blood- and plasma-derived products
- Food supplements
- Gene Therapy Medical Products (GTMPs; e.g., GMOs, therapeutic vectors)
- Laboratory surfaces (e.g., cleaning validation)
- Medical devices
- Monoclonal antibodies and derivatives
- Products of different occupational exposure bands (OEB)
- Recombinant proteins
- Tissue-derived products
- Urine-derived products (e.g., hormones)
- Vaccines
Viral Clearance: Advancements in Virus Production and Purification to Address ICHQ5A Updates
Updates to the ICH Q5A guidelines are generating new interest in virus titer and purity in viral clearance studies. Hear our experts share insights into new methods and developments in the production process of viruses you can use in your studies.
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Viral Clearance Services and Study Types
We offer risk-based assessments to optimize clients' viral safety testing programs. This is achieved through holistic study design, which scrutinizes pretesting, virus spikes, and assay sensitivities among others. We optimize all of our viral clearance studies for sensitivity with a standard inclusion of large volume plating for all product-relevant samples in order to improve LRV claims and demonstrate effective and robust virus reduction.
To ensure smooth communication and on-time delivery of projects, a dedicated project manager and study director will be assigned to your project and provide you with a comprehensive and flexible reporting package. Both during and after your projects we ensure a safe exchange of documents via our secure Apollo™ cloud-based platform.
Specific arrangements can also be made for enhanced support for long-term viral clearance validation programs. Our site also offers multi-spike approaches that are characterized for use in viral clearance studies under GLP and allow testing of several viruses within one single run. In addition, gamma irradiation as a viral clearance step is available through an external service provider.
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Compliance, Certifications, Accreditations and Professional Affiliations
As a global biopharmaceutical manufacturing and testing organization, we take pride in the support we provide to our clients to get their monoclonal antibodies, recombinant proteins, and other biologics to market faster. To support our European and international partners, our Cologne facility operates in compliance with Lean Six Sigma principles and the following international regulatory agencies or accredited organizations.
- German Chemical Law
- Directive 2004/9/EC
- Organization for Economic Co-operation and Development (OECD) GLP Certificate
- Code of Federal Regulations (CFR) 21 Part 58
- European Medicines Agency (EMA)
- U.S. Food and Drug Administration (FDA)
- International Conference on Harmonisation (ICH)
- Korean Ministry of Food and Drug Safety (MFDS)
- Japanese Ministry of Health, Labour and Welfare (MHLW)
- Medicines and Healthcare products Regulatory Agency (MHRA)
- Good Laboratory Practice (GLP)
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Quality and Process Initiatives
- Operational Excellence
- Lean Six Sigma program
- Excellent regulatory compliance history
Get Your Biologics Data When You Need It with Apollo
Charles River's Apollo is a secure, cloud-based platform that empowers you with real-time access to your biologics sample data, milestones, and documents all in one centralized location.
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Interested in conducting a viral clearance study?