Biologics Testing CRO Services Tour
Our state-of-the-art biologics testing laboratories provide you with access to a wide range of biologics testing services that include cell line characterization, contamination testing, stability programs, lot release testing, and a comprehensive viral clearance testing offering. This site has harmonized its procedures with our viral clearance testing site in Cologne, Germany.
Watch this video to see the journey of a viral clearance sample at our Wayne facility.
Laboratories and Facilities
- 400+ employees
- 72,000+ square feet (6,689 meters)
- Extensive site security and monitoring systems
- Document control and archive capacity
- Sample processing and storage
- On-site IT support services
- Biosafety level 2 services
- DI water, CO2 and N2 gas, and pressurized air
- Good Manufacturing Practice (GMP) compliant
GMP Biologics Services
Our team has over 20 years of experience offering a comprehensive range of analytical studies including reference standard characterization, stability, method development, phase-appropriate validation, and release testing.
Laboratory Features Overview
- Dedicated client labs and guest offices
- Biosafety Level 2 and Level 2 enhanced for handling of biological agents (including HIV)
- State-of-the-art laboratory equipment includes:
- Temperature and pressure monitoring
- Deionized water, CO2 and N2 gas, and pressurized air
- Chiller range from (-50 °C) to (+200 °C)
- Cold rooms (for processes performed at +2 to +12 °C)
- Cryogenic and thermostatic water baths
- Fully qualified and validated ÄKTA Avant and ÄKTA Pure systems
- Lyophilizers
- Vacuum drying oven
- Biosafety cabinets class II and chemical fume hood
- Equipment for all common virus retentive filters
- Ultracentrifuges and classical centrifuges (various sizes)
- Photometers (nanodrops), conductivity meters, pH meters
- Dedicated cell culture suite for readily available cell culture stocks
Viral Clearance Services
- Selection of process steps
- Selection of high titer viruses
- Optimization of viral clearance study design
- Performance and support of all process steps including chromatography and filtration
- Fully qualified, state-of-the-art equipment
- Interpretation of results and support with troubleshooting (extensive database of over 13,000 studies process runs)
- Comprehensive and flexible reporting
- Regulatory consultation for study planning (Europe, US, Japan)
Biologics Testing Services and Study Types
- Cell line characterization
- Biosafety testing:
- Replication competent viral vectors
- Adventitious viral agent
- Microbiology services
- Rapid and compendial sterility testing
- Mycoplasma testing
- Bioburden testing
- Release testing
- Stability testing
- Method development, transfer, and validation
- In Vitro Bioassay Services
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 and efficacy studies)
- 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 Compliance, Certifications, Accreditations, and Professional Affiliations
We provide comprehensive and flexible reporting tailored to your needs and pair this with on-site seminars and training for seamless integration. To ensure your project is smooth and well-coordinated, dedicated project managers are assigned to each client, prioritizing your satisfaction.
For those clients requiring extensive and ongoing service contracts, we also offer specific arrangements for long-term agreements, backed by a client portal that enables efficient document exchange and effortless communication.
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.
Watch Webinar
Biologics Analytical Testing Solutions
Specializing in a broad range of CGMP in vitro capabilities, our facility supports the testing of biologics, cell and gene therapies, vaccines, antibody-drug conjugates, and biosimilars.
Areas of Biologics Testing Service Offerings
| Identity | Content and Potency | Purity and Impurities | Physiochemical Properties | Physical Attributes |
| SDS-PAGE with western blot or CE-SDS | Cell-based potency assays | Residual host cell proteins (HCP) | pH determination | Visual assessment |
| Isoform analysis (IEF, C-IEF) | In vivo potency | Size-exclusion HPLC (SEC) | Osmolality determination | Determination of volume in syringes and vials |
| Peptide map | Protein concentration | Cation-exchange HPLC | — | Determination of excipient levels |
| — | Binding assays (ELISA) | Reverse-phase (RP) HPLC | — | Sub-visible particulates |
| — | — | CE-SDS, C-IEF | — | Moisture content |
*Peptide mapping is only offered to clients with existing methods, clients who have developed the method elsewhere and are transferring in the HPLC method, or clients who have GER perform the mass spec method development and transfer the testing to Charles River. It is not available as a stand-alone service.
Analytical Services
According to current regulatory guidelines, extensive analysis is necessary to establish a well-characterized biologic or to demonstrate comparability between a biosimilar and the reference product. Due to these regulatory requirements, analytical testing plays a critical role in process development and the manufacturing of biopharmaceuticals.
Our skilled analytical chemistry staff has worked with a broad spectrum of molecules, including peptides, lipids, proteins, glycoproteins, protein conjugates, plasmids, adeno-associated viral vectors (AAV), and synthetic peptides. Our analytical capabilities allow us to tailor a characterization plan to suit the needs of your product.
Process-Related Residuals
Ensure your product is free from:
- Protein A
- Polyethylamine immine (PEI)
- Antifoams
- IPTG
- Antibiotics
Product-Related Impurities
- N-Terminal truncations
- Aggregation
Biophysical Characterization
Correct higher order structure (HOS) is critical to ensuring proper functionality, activity, and stability of a biopharmaceutical product. A well-developed panel of methods for HOS characterization is an essential component of a complete product characterization program.
As part of a robust HOS characterization program, our facility provides the following tests:
- Aggregation & Sizing
- Analytical ultracentrifugation (AUC)
- Electrophoresis via SDS PAGE and CE-SDS
- Sub-visible particulate measurement via HIAC
- Assessment of Forced Degradation Studies
Global Viral Clearance Strategy
During our 30 years in the industry, we have conducted thousands of viral clearance studies and achieved a 98.6% client satisfaction rating. We provide regulatory consultations for study planning to support a broad range of global regulatory submissions within the US, EU, and APAC and will provide dedicated on-site support during agency visits, whether they take place at the agency or at your facility during a site audit. Our site also offers a GMP/GLP validated co-spike approach that expertly combines testing for MuLV and MVM in a single run.
Viral Clearance Study Types
We offer a 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 project delivery, a dedicated scientist (study director) will be assigned to your project and provide you with a comprehensive and flexible reporting package.
Our site also offers co-spike/multi-spike approaches that are characterized for use in viral clearance studies under GMP, which allow testing of several viruses within one single run.
Additionally, irradiation such as gamma, E-beam, X-ray, is available as a viral clearance step through an external service provider.
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International Regulatory Compliance
- US Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- Health Products Regulatory Authority (HPRA)
- US Department of Agriculture (USDA)
- Korean Ministry of Food and Drug Safety (MFDS)
- Japanese Ministry of Health, Labour, and Welfare (MHLW)
- Medicines and Healthcare Products Regulatory Agency (MHRA)
Accelerating Viral Clearance Studies – A Co-Virus Spike Approach
In this webinar, we present a new MuLV-MVM co-virus spike approach that has been developed, and how it can significantly reduce materials, time, and labor required.
Watch Webinar
Interested in conducting a study?