Biosafety Testing

Biosafety testing is a critical requirement for ensuring the safety and compliance of biological products, from recombinant proteins and nucleic acids to viral seeds, cell banks, and finished biopharmaceuticals. Regulatory authorities such as the U.S. FDA and EMA mandate stringent testing protocols to safeguard patients and maintain product integrity. Creative BioMart, a trusted leader in biopharmaceutical testing, offers comprehensive Biosafety Services across virology, microbiology, molecular biology, and electron microscopy. With state-of-the-art technologies, in-house expertise, and regulatory alignment, we provide accurate, timely, and cost-effective solutions that ensure product safety while accelerating your path to market.

Introduction to Biosafety Testing

Biological products are inherently complex and carry the risk of contamination with adventitious agents such as bacteria, fungi, mycoplasma, or viruses. Moreover, impurities such as residual DNA, proteins, or other process-related contaminants can compromise product safety and efficacy. To meet global regulatory expectations, thorough biosafety testing is mandatory throughout the product lifecycle—from research and preclinical development to clinical and commercial production.

Creative BioMart supports clients worldwide with a complete portfolio of biosafety services designed to detect potential hazards early, minimize risks, and ensure compliance with international standards. Our expertise, combined with advanced analytical platforms, makes us a reliable partner for biopharmaceutical developers.

Our Comprehensive Biosafety Testing Solutions

We deliver end-to-end biosafety testing services tailored to your program needs, including:

Cell Bank Testing

Mycoplasma detection, microbial sterility, and viral contaminant testing.

Viral Seed Characterization

Adventitious virus detection, retrovirus assays, and inapparent virus testing.

Tumorigenicity & Toxicity Tests

Abnormal toxicity and tumorigenicity studies conducted in vivo.

Residual Impurity Analysis

Testing for residual DNA, proteins, and other process-related impurities.

Immunological & Molecular Assays

Quantitative real-time PCR assays, immunological analyses, and cell culture–based assays.

Pathogen Screening

Comprehensive testing for blood-borne pathogens and other infectious agents.

Formulation & Stability Studies

Long-term product stability and safety evaluations.

Regulatory Consulting & Custom Assays

Tailored assay development and compliance consulting to meet specific regulatory guidelines.

Service Workflow

Service Details

Features	Details
Core Assays	Quantitative real-time PCR Retrovirus assays Cell culture–based assays In vivo testing: viral contaminants, inapparent viruses, abnormal toxicity, tumorigenicity Immunological assays Blood-borne pathogen screening
Regulatory Compliance	All assays are conducted under the guidance of international standards, including FDA, EMA, USP, EP, and ICH guidelines. We ensure that every test is performed with accuracy, reproducibility, and full traceability.

Why Partner with Us for Biosafety Testing

Comprehensive Portfolio: Covering virology, microbiology, molecular biology, and electron microscopy.

Regulatory Alignment: All testing conducted in compliance with FDA, EMA, and ICH guidelines.

In-House Expertise: Highly trained specialists perform almost all assays internally, ensuring quality and fast communication.

Reliable Turnaround: Rapid delivery of results to keep your development timeline on track.

Cost-Effective Solutions: Competitive pricing without compromising scientific rigor.

Trusted Partner: Proven track record supporting biologics safety testing across preclinical, clinical, and commercial stages.

Real-World Biosafety Testing Case Studies

Case 1: Viral contamination in biologic manufacture and implications for emerging therapies

Barone et al., 2020. doi:10.1038/s41587-020-0507-2

Although recombinant protein therapeutics, vaccines, and plasma products have a strong safety record, cell culture–based production remains vulnerable to viral contamination. Such events, while rare, can be costly, delay patient access to therapies, and provide limited opportunities for learning. To address this, a consortium of biotech companies and the Massachusetts Institute of Technology collected and analyzed data on historical contamination incidents. The study identified common viral contaminants, their sources, affected cell lines, and corrective actions taken. These findings offer critical insights to enhance the safety and reliability of current biologics production and emerging cell and gene therapies.

Figure 1. Virus testing of contaminated processes. Virus tests on samples from different process steps of the affected runs during investigation of the contamination events reported to the CAACB. (Barone et al., 2020)

Case 2: Assessing safety of retroviral and lentiviral vectors

Bauer et al., 2008. doi:10.1038/mt.2008.93

Serious adverse events in human gene therapy trials have raised concerns regarding the use of retroviral and lentiviral vectors. To evaluate these risks, human hematopoietic stem and progenitor cells (HSCs) and mesenchymal stem cells (MSCs) transduced with Moloney murine leukemia virus (MoMuLV)-based or lentiviral vectors were transplanted into immune-deficient mice and monitored for up to 18 months. No evidence of insertional mutagenesis, replication-competent retrovirus (RCR), leukemia, solid tumors, or vector-associated adverse events was detected. These findings demonstrate that this in vivo system provides a robust assessment of vector safety, supporting the safe design of clinical gene therapy applications.

Figure 2. Neo PCR for mice that carried human leukemic samples. DNA samples obtained from the mice that carried human leukemic cells were subjected to PCR for the neo gene so as to determine whether proviral integration might have contributed to the leukemic transformation. Samples, from left to right: Positive control = the PA317/ SV-neo (clone B) cell line, containing one copy of the neo gene per cell; negative control = PA317 cells; sample 1 = mouse #312, bone marrow; sample 2 = mouse #312, spleen; sample 3 = mouse #312, blood; sample #4 = mouse #205, bone marrow; sample 5 = mouse #205, spleen; sample 6 = mouse #205, blood. (Bauer et al., 2008)

What Customers Say About Our Biosafety Testing Services

"Creative BioMart supported our vaccine program by conducting comprehensive viral seed characterization, including inapparent virus detection, retrovirus assays, and electron microscopy. Their team worked under GMP conditions and provided a clear, well-documented data package that was accepted by regulatory authorities without issue. Their ability to deliver results within our tight submission timeline was invaluable."

— Head of Vaccine Development | Global Biopharmaceutical Company

"For our stem cell–based therapeutic, Creative BioMart performed in vivo tumorigenicity studies and abnormal toxicity testing. The results were delivered ahead of schedule, with thorough reports that aligned perfectly with FDA guidance. Their technical expertise and transparent communication gave us confidence to move forward with our IND application."

— Director of Translational Research | Mid-Sized Cell Therapy Company

"We partnered with Creative BioMart to evaluate residual DNA and host cell protein levels in our recombinant protein production process. Their quantitative PCR assays and immunological tests were precise, reproducible, and clearly presented in the final documentation. The data package they provided helped us address regulatory questions efficiently and accelerated approval of our manufacturing protocol."

— Senior Scientist, Process Development | Contract Manufacturing Organization (CMO)

"Our clinical-stage oncology program required extensive testing of human-derived samples for blood-borne pathogens, including HIV, HBV, and HCV. Creative BioMart’s biosafety team managed the entire process seamlessly, from assay design to final reporting. Their fast turnaround and regulatory expertise ensured patient safety and allowed us to proceed with confidence into Phase I trials."

— Clinical Operations Director | Oncology Biotech Company

FAQs About Biosafety Testing Services

• Q: What types of products do you provide biosafety testing for?

  A: We test a wide range of biological materials, including recombinant proteins, nucleic acids, cell banks, viral seeds, vaccines, human-derived samples, and biopharmaceutical final products. Our services ensure compliance with FDA, EMA, and ICH regulatory requirements.

• Q: What biosafety tests do you offer?

  A: Our portfolio includes quantitative PCR assays, retrovirus assays, cell culture–based assays, in vivo testing (viral contaminants, inapparent viruses, abnormal toxicity, tumorigenicity), immunological assays, blood-borne pathogen testing, and residual DNA/impurity analysis. We also perform formulation and stability studies as well as custom assay development.

• Q: Do your services meet international regulatory standards?

  A: Yes. All of our biosafety testing is performed in line with major pharmacopeias and global regulatory guidelines (FDA, EMA, USP, EP, and ICH). This ensures that our data packages are suitable for regulatory submissions worldwide.

• Q: How quickly can I expect results?

  A: Turnaround time depends on the complexity of the study. Standard assays such as microbial detection or PCR can be completed in 1–2 weeks, while in vivo tumorigenicity or viral clearance studies may take longer. We always provide a customized timeline during project initiation and prioritize regulatory deadlines.

• Q: Are the assays conducted in-house?

  A: Almost all assays are performed in-house by our highly trained specialists. This not only ensures data integrity and quality control but also allows for faster communication and quicker turnaround times.

• Q: Can you customize biosafety testing for unique projects?

  A: Absolutely. We offer flexible, project-specific assay development and consulting services. Whether you need a custom PCR assay for a novel viral contaminant or tailored impurity testing, we can design solutions to meet your exact needs.

References:

1. Barone PW, Wiebe ME, Leung JC, et al Viral contamination in biologic manufacture and implications for emerging therapies. Nat Biotechnol 2020;38(5):563-572. doi:10.1038/s41587-020-0507-2
2. Bauer G, Dao MA, Case SS, et al. In vivo biosafety model to assess the risk of adverse events from retroviral and lentiviral vectors. Molecular Therapy. 2008;16(7):1308-1315. doi:10.1038/mt.2008.93