Merck

Safety is Everything

Biologics testing partner of choice

BioReliance® Contract Testing

Choosing the right partner for analytical and biosafety testing is critical in the race to approval. Our BioReliance® Contract Testing Services offer exceptional, risk-mitigating solutions with technical and regulatory expertise, to help bring life-changing drugs to market.

Our testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. Clients partner with us to meet their needs for biologics safety testing, analytical development, and biomanufacturing services.

A Reputation for Shaping the Biotesting Industry

We’re entrusted with the safety of the world's biologics because for us, safety is everything. We balance risk to optimize speed to market without ever compromising on safety or quality. Our strength is our people, and with 75+ years of trusted expertise, we’re the partner of choice for biomanufacturers.

Our proudest innovations include:

1955

Developed polio vaccine biosafety protocols

1960

Developed mouse antibody test in collaboration with the U.S. NIH

1983

Started biosafety testing for the first licensed monoclonal antibody product

2007

Characterized the first U.S. national stem cell banks

2023

Leveraging the power of Next Generation Sequencing (NGS) and our proprietary Blazar® platform to accelerate testing and reduce the use of animals


The Value We Provide

Technology Leadership
Technology Leadership

Known for our broad portfolio & expertise – with standard setting innovation & template development to push the industry forward.

Technology Leadership
Global Capacity and Supply Chain Management

Flexibility through manufacturing and testing capacity – making significant investment in our capabilities and capacity to scale with client's complex supply chain needs.

Extensive Regulatory Knowledge
Extensive Regulatory Knowledge

Decades of experience to inform and navigate client’s pathways to approval. Our global regulatory know-how ensures quality standards and compliance are met.


Across the biosafety and regulatory landscape

BioReliance® analytical development services

Analytical Development

Orthogonal approaches to product characterization support better understanding of an asset's performance, safety, and the manufacturing processes for Drug Substance (DS) and Drug Product (DP).

Identity, purity, strength, and potency should be considered collectively to inform the best decisions about: Where and how to act, setting specifications, and understanding performance.

A subset of approaches should move into Analytical Development to formalize assays to support testing under GMP required for Critical Quality Attributes (CQAs) defined by ICH Q6B.

It is important to recognize that all modalities and processes are different, but the attributes defining quality are consistent and must be understood and monitored.

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ADCs

With ADCs, it is important to look beyond drug-to-antibody ratio (DAR). Understanding how post- translational modifications and conjugation may affect binding and potency is an important consideration that affects internalization and ultimately, potency.

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mAbs

How well do you understand the structure-function relationship with your molecule? With mAbs, it is important to understand binding performance, covalent modifications (post translational modifications and/or unintentional modifications) and how those factors affect performance.

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mRNA

Given the unique characteristics of the mRNA/LNP complex, new expertise and a series of novel analytical capabilities are required to ensure fast, efficacious, and compliant mRNA-based vaccines and therapeutics. We provide testing services for mRNA starting materials, drug substance, and drug product.

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Cell & Gene Therapy

AAV therapies are complex and present unique challenges to monitor quality and performance. These activities require careful planning and management of orthogonal techniques (e.g., analytical, structural, and molecular). Breadth of capabilities and coordination are key to success.

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Support for all phases of biopharmaceutical drug development

In any stage of the biopharma development process, our leading GMP-compliant biosafety services and regulatory knowledge can help biomanufacturers progress their therapeutic from discovery to release.

*Microbiology assays and other methods for adventitious agent detection
**Support for IND and BLA enabling studies


CTDMO map

A Global Footprint

We are a single organization with a global network to deliver testing services across all stages of the molecule value chain.

Our state-of-the-art testing network consists of four major sites near global biopharma hubs. Ongoing investments to expand capacity across all locations will help us meet the growing demand for robust biosafety testing studies for traditional and novel therapies.

Production Site - Shanghai, China
Shanghai, China

Our Shanghai site is home to our China Biologics Testing Center, which houses viral clearance suites. This enables clients to locally conduct viral clearance studies from pre-clinical development to commercialization for in China and for global export.

Glasgow, Scotland
Glasgow, Scotland

Our biosafety testing service site houses our cell bank manufacturing, biorepository, cell line characterization, and drug substance and drug product release testing services.

Stirling, Scotland
Stirling, Scotland

Our site features viral clearance study suites. Our Provise™ Clearance Service deploys a team of highly trained & experienced process scientists and study directors on your behalf, to perform all your required process steps at our state-of-the-art Stirling facility.

Singapore
Singapore

Our Biosafety testing services site conducts cell line characterization, viral clearance, and drug substance and drug product release testing.

Rockville, United States
Rockville, United States

Biosafety testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. Services include analytical development, cell banking, cell line characterization, viral clearance, drug substance and drug product release testing, as well as rapid methods.

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