How Biosafety Level 2 Labs Ensure Safe and Compliant In Vitro ADME Studies

Biosafety Level 2 (BSL-2) laboratories, classified under the World Health Organization (WHO) standards, provide a controlled environment for handling moderate-risk biological materials, including human-derived matrices and potentially hazardous compounds. At WuXi AppTec DMPK, our in vitro ADME studies involving human-derived matrices are conducted exclusively in P2-certified labs. This ensures compliance with regulatory standards, while prioritizing the safety of our researchers and the integrity of data.

Watch our video: In Vitro ADME Biosafety Level 2 Labs at WuXi AppTec DMPK

When do we use a P2 lab for in vitro ADME studies?

Our state-of-the-art BSL-2 facilities span thousands of square meters, supporting critical ADME research scenarios, including:

• Studies using human-derived matrices

Conducting in vitro ADME studies using human-derived matrices helps to predict the pharmacokinetic behavior of drugs more accurately in humans. To mitigate the health risks from potential pathogens, all such studies are conducted in BSL-2 environments. Examples include: metabolic or protein binding testing in human blood, plasma, hepatocyte, subcellular matrices and tissues, and metabolism-mediated inhibition/induction studies, etc..

• High-risk compounds

Antibody-based therapeutics and compounds with high occupational exposure band (OEB) ratings require stringent containment to protect researchers and prevent environmental contamination.

• Clinical samples

We handle clinical samples in full compliance with international biosafety regulations, ensuring both ethical standards and scientific rigor.

Our best practices for excellence in lab management

Strategic lab design: Our labs are logically divided into zones (auxiliary, protective, and core areas) to prevent contamination. Workflows follow a “clean-to-contaminated” path, minimizing exposure risks.

Key safety equipment: Every researcher wears PPE, and equipment like biological safety cabinets, steam sterilizers, and automated pass-throughs are rigorously maintained. Regular audits guarantee that everything aligns with regulatory guidelines.

Training, compliance, and technology: Staff undergo regular training on biosafety operations, waste management, and emergency procedures. Cloud-based monitoring tracks lab conditions in real time, and a highly integrated automation platform conducts the assays, reducing manual error and enhancing reproducibility.

Final thoughts

By integrating rigorous safety measures with operational precision, we protect researchers, prevent environmental hazards, and deliver reliable data that accelerates drug discovery. Whether navigating complex ADME studies or handling high-risk compounds, our labs provide the safety and compliance needed to meet global standards.

Talk to a WuXi AppTec expert today to get the support you need to achieve your drug development goals.

Committed to accelerating drug discovery and development, we offer a full range of discovery screening, preclinical development, clinical drug metabolism, and pharmacokinetic (DMPK) platforms and services. With research facilities in the United States (New Jersey) and China (Shanghai, Suzhou, Nanjing, and Nantong), 1,000+ scientists, and over fifteen years of experience in Investigational New Drug (IND) application, our DMPK team at WuXi AppTec are serving 1,600+ global clients, and have successfully supported 1,700+ IND applications.