Our BioReliance® biosafety testing and analytical development services deliver risk-mitigating solutions with technical and regulatory expertise. We have been shaping the biosafety testing industry for more than 75 years. We help ensure the safety of the world’s biologics with innovations such as:
- Supported and tested the first polio vaccines
- Tested lunar samples from NASA
- Began biosafety testing for the first licensed monoclonal antibody product in 1983
No. 1 for clients: New Paradigms in Biosafety Testing that put Our Clients Ahead
Helping to navigate the regulatory landscape: ICH Q5A(r2)
The recent revision of ICH Q5A encourages the use of new technologies and viral clearance strategies to ensure viral safety of biologics. Viral safety assurance of gene therapies, virus-like particles, and viral vector products is now required.
A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory requirement. ICH Q5A, the globally-harmonized guideline outlines the expectations. It has recently been revised to address scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and advanced detection technologies.
Regulations are changing to be more accepting / even encouraging the adoption of new technologies.
Biologics such as monoclonal antibodies and gene therapies are a significant portion of the therapeutics market. ICH Q5A outlines regulatory expectations for viral risk mitigation in biologics manufacturing. The revision encourages the use of Next Generation Sequencing (NGS) and PCR-based technologies.
Accelerating Development with the Award-winning Blazar® Platform
In today’s environment speeding biologics to market is more important than ever. The Blazar® platform not only helps accelerate CLC but allows clients to meet corporate objectives to reduce in vivo testing. Innovative molecular methods enable mAbs manufacturers to deliver critical therapeutic agents to patients faster. The Blazar® CHO AOF virus panel is a powerful tool to accelerate bulk harvest testing with the potential to replace slower culture-based in vitro virus detection methods.
The platform is a novel degenerate PCR assay for the detection of a broad range of adventitious agents. With the advantages of sensitivity, accuracy, and faster results, combined with the ability to detect a very broad range of viruses, this platform is well suited to cell line characterization and bulk-harvest lot release testing.
We are committed to accelerating testing and helping the industry reduce the use of animal models. We have developed a rodent virus panel for the Blazar® platform. This rodent virus panel provides a suitable alternative to the current in vivo MAP/HAP/RAP test that eliminates the need for animals.
Speed. Sustainability. Safety. Pioneering NGS applications
Revolutionizing the development and analysis of biologic therapeutics, NGS allows you to meet the challenge of rapidly characterizing your products, while identifying known and unknown agents with pinpoint precision and accuracy.
Our suite of NGS services is based on complementary technology platforms that rapidly generate deep sequencing datasets for comprehensive data analysis, backed by biosafety experts who deliver intelligent results tailored to your unique testing needs.
As a leading service provider, we have pioneered the use of NGS to expand our portfolio of GMP testing services, including the use of NGS to detect and identify adventitious agent sequence signatures that may be present in a test sample. This application of NGS affords the biopharmaceutical industry with a valuable tool to mitigate the risk of viral contamination in a variety of samples from production starting materials to bulk harvests and final product.
The ability of NGS-based methods for agnostic broad range detection makes it a suitable option to augment or replace current virus testing methodology.
Regulatory authorities are receptive to the use of novel technologies as alternatives to established virus detection methods, as long as the alternative testing strategies are properly validated, shown to be fit for purpose for the sample being tested, and are comparable or better than existing assays.
Timeline of Firsts
| 1947 |
| Produced a single product, serum ultra filtrate for the newly-emerging tissue culture field. |
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| 1951 |
| First commercial supplier of cell cultures and reagents. |
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| 1955 |
| First contract R&D program with U.S. Govt and National Foundation for Infantile Paralysis to support development and production of the first polio vaccines. |
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| 1956–1960 |
| Started producing viral diagnostic products. |
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| 1960s |
| Collaboration with the NIH, developed new technologies for viral disease diagnoses of laboratory animals. Developed the Mouse Antibody Production (MAP) test. |
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| 1969 |
| Supported NASA in development of safety testing protocols for lunar samples brought back from the moon’s surface. |
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| 1978 |
| First to license and market an ELISA diagnostic test for detection of cytomegalvovirus (CMV). |
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| 1981 |
| Together with Genentech, established the original biosafety testing program for what becomes the first licensed therapeutic derived from mammalian cells (Activase). |
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| 1983 |
| Began biosafety testing for what becomes the first licensed therapeutic monoclonal antibody product (Ortho Pharmaceutical’s Orthomune OKT-3). |
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| 1988 |
| Tested the first genetically engineered microbial pesticide to be approved by the EPA for field trials (Bacillus thunringiensis). |
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| 1989 |
| First major R&D collaboration to develop and validate a transgenic mouse for safety testing of chemical products (Strategene’s Big Blue®). |
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| 1990 |
| Developed first protocols and evaluate the first gene therapy products allowed into human clinical trials by the FDA. |
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| 1994 |
| Conducted safety testing for the first liver transplanted from a baboon to a human. |
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| 1995 |
| Performed analytical testing of pharmaceuticals, focusing on macromolecules and providing characterization services using analytical techniques. |
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| 2007 |
| Introduces iNet client portal to facilitate sample submission and client access to study results. |
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| 2020 |
| Launch of award-winning Blazar® platform. |
Related Resources
ICH Q5A White Paper: Regulatory Considerations for Implementation of Alternative Microbial
ICH Q5A Webinar: How to Leverage the ICH Q5A Guidance to Implement the Next Generation of QC Testing
Blazar® CHO AOF Platform Webinar: A Rapid Innovative Approach to Release Testing with Blazar® CHO ADF Virus Panel
Services
Biologics Testing, Product Characterization
We deliver brilliant biosafety testing experiences through the entire drug lifecycle. Our comprehensive product characterization program reveals the true identity of your molecule through every phase of development, ensuring your biotherapy’s safety, purity and potency.
Explore our pharma and biopharma testing services in more depth:
Biopharma Testing Services
The Sharpest Perspective in Life Science
BioReliance® Contract Testing Services
No. 1 for Innovation
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