5 Biologics Safety Testing Leading Companies

Published: August 2026

Biologics are intricate therapeutic agents made up of complex biomolecules such as proteins, carbohydrates, nucleic acids, or combinations thereof typically produced using living cells. These molecules are highly sensitive to environmental factors like temperature, light, pH, and oxygen exposure. Because of their complexity, biologics carry potential safety concerns, including immunogenicity, risk of contamination, and variability between production batches. As a result, thorough safety testing is essential to confirm that these molecules are free from harmful impurities, consistently potent and effective, and safe for human administration.

Overall, biologics safety testing is a comprehensive and stringent evaluation process that verifies the safety, purity, potency, and batch-to-batch consistency of these therapies prior to their use in clinical trials or commercial release.

Roots Analysis has conducted an exhaustive study on Biologics Safety Testing Market featuring the current market landscape and future opportunities for companies engaged in biologics safety testing market over a span of next 9 years.

Top Five Biologics Safety Testing Leading Companies:

Sartorius
SGS
NI Labs
Charles River Laborateries
MilliporeSigma (BioReliance)

The figure below highlights the top five Biologics Safety Testing Leading Companies:

Top 5 Companies to Watch Biologics Safety Testing Market

Interested in exploring all ~180 players engaged in the biologics safety testing market, along with their recent initiatives?

Discover Below the Details on Top 5 Biologics Safety Testing Leading Companies

Let us dive deep into the details of the top 5 biologics safety testing leading companies. It is essential to note that the selection of top companies developing biologics safety testing solutions can differ substantially according to the defined criteria.

1. Sartorius

Sartorius is a leading provider of bioprocess and laboratory solutions, and offers comprehensive biologics testing services, including extensive biosafety testing packages performed in accredited, cGMP-compliant facilities. The company claims to provide services from cell bank characterization to final drug product release, featuring both off-the-shelf and custom-validated methods. It is important to highlight that Sartorius provides comprehensive biosafety testing services compliant with global pharmacopoeia standards, carried out in facilities accredited with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK.

Sartorius: Company Overview

	Company Name	Year of Establishment	Headquarters	Number of Employees
	Sartorius	1870	Germany	10,001+

To know more about the recent initiatives of Sartorius and other companies involved in biologics safety testing industry, access full report.

2. SGS

SGS is a global provider of biologics safety testing solutions, supporting pharmaceutical and biopharmaceutical companies across all stages of drug development. Its bioanalysis services combine scientific expertise, advanced instrumentation, and regulatory compliance to deliver accurate and reproducible data. SGS delivers comprehensive biosafety services, including mycoplasma detection, sterility testing, endotoxin assays, adventitious virus screening, and viral clearance validation to ensure the safety, purity, and potency of monoclonal antibodies, vaccines, cell and gene therapies, and biosimilars. With its compliant laboratories strategically located worldwide, the company ensures high-quality results that meet international regulatory standards.

SGS: Company Overview

	Company Name	Year of Establishment	Headquarters	Number of Employees
	SGS	1877	Switzerland	10,001+

Recent Developments

In July 2026, SGS announced the launch of SGS Biosafety Laboratory as the new market-facing name for its specialist biosafety facility in Glasgow, with the aim to strengthen its capabilities in biologics, vaccine and advanced therapy testing.

To know more about the recent initiatives of SGS and other companies involved in biologics safety testing industry, access full report.

3. NI Labs

NI Labs specializes in advanced automated test and measurement systems tailored for the biotechnology and pharmaceutical sectors. Their biological safety testing solutions leverage modular hardware and software platforms to enable precise, reliable, and compliant testing of biologics, medical devices, and laboratory processes. These systems support critical applications such as sterility testing, environmental monitoring, equipment validation and regulatory compliance with standards like FDA, ISO, and GMP requirements. By integrating high-performance data acquisition, real-time control, and customizable software like LabVIEW, NI empowers labs to conduct automated biological safety assessments with enhanced accuracy, traceability, and efficiency

NI Labs: Company Overview

	Company Name	Year of Establishment	Headquarters	Number of Employees
	NI Labs	1936	US	11-50

To know more about the recent initiatives of NI Labs and other companies involved in biologics safety testing industry, access full report.

4. Charles River Laborateries

Charles River Laboratories is a leading global contract research organization (CRO) that provides pre-clinical and clinical development services to the pharmaceutical and biotech industries. Founded in 1947, the company offers a range of services, including toxicology testing, efficacy testing, and safety testing, as well as clinical trial management and pharmacovigilance. Notably, Charles River Laboratories has over 100,000 square feet of laboratory space across 15 countries and employs over 20,000 scientists and professionals. The company offers a comprehensive suite of GMP-compliant services tailored to biologics, focusing on biosafety, purity, and potency.

Charles River Laboratories: Company Overview

	Company Name	Year of Establishment	Headquarters	Number of Employees
	Charles River Laboratories	1947	US	10,001+

To know more about the recent initiatives of Charles River Laboratories and other companies involved in biologics safety testing industry, access full report.

5. MilliporeSigma (BioReliance)

MilliporeSigma, life science business of Merck KGaA, Darmstadt, Germany, offers comprehensive biologics safety testing through its BioReliance® contract testing services. It is a leading provider of biosafety testing and analytical development solutions, specializing in risk-mitigating approaches to ensure the purity, safety, and efficacy of biologic drugs, including monoclonal antibodies, cell and gene therapies, and other advanced therapeutics. Their portfolio includes critical services such as cell line characterization, viral clearance studies, adventitious agent testing, genetic stability assessments, raw material testing, product release testing, and product characterization assays compliant with ICH Q6B, FDA, EMA, and other regulatory standards.

MilliporeSigma (BioReliance): Company Overview

	Company Name	Year of Establishment	Headquarters	Number of Employees
	MilliporeSigma (BioReliance)	1947	US	5,001-10,000

Recent Developments

In July 2026, MilliporeSigma (BioReliance) announced the opening of new testing facility at its global headquarters in Darmstadt, Germany. The facility expands access to commercial drug substance and drug product release testing as well as stability testing for biopharmaceutical companies developing and commercializing therapies in Europe.

To know more about the recent initiatives of MilliporeSigma (BioReliance) and other companies involved in biologics safety testing industry, access full report.

What About Other Biologics Safety Testing Solution Providers Around the World?

The above article features the top five companies developing biologics safety testing solutions. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.

Sources: