Biologics
Delivering End-to-End Testing Solutions for Biologics, Ensuring Precision and Compliance at Every Stage
Industry focus
GLP and non-GLP Safety/Toxicology Studies for Biologics
We conduct the entire range of Good Laboratory Practice (GLP) and non-GLP safety studies for the development of biologics. The test facility has 20+ years of experience in conducting biologics studies for novel biologics, biosimilar monoclonal antibodies & Fc fusion proteins, Antibody-Drug Conjugates (ADCs), peptides, vaccines, oligonucleotides, and cell and gene therapy products.
From early drug development through to commercial release, our services are designed to support critical milestones and guarantee adherence to international regulatory guidelines- helping you bring safe, effective biologics to market in confidence
Core capabilities
- Bioassays- GMP batch release testing
- Immunogenicity
- PK, TK & Biodistribution
- Customised polyclonal antibody generation, purification and characterisation
- Advanced cell & gene therapy
- Genomics & Toxigenomics
- Toxicology studies
- Regulated bioanalysis
- Biomarker analysis
Regulatory Credentials
Regulatory & Quality Credentials
- First GLP-Accredited in India
We are the first GLP-accredited laboratory in India and has been successfully audited by the USFDA (2012 and 2016) for GLP studies submitted as part of IND/NDA packages.
- Certified Quality Standards
Our vivarium was the first to have been accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) since 2001 and all animal study protocols are reviewed and approved by the Institutional Animal Ethics Committee (IAEC), which is equivalent to Institutional Animal Care and Use Committee (IACUC).
- Regulatory-Ready SEND Data
We deliver validated, submission-ready SEND datasets delivered via the FDA-required Submit™ platform
Proven Experience
Established Expertise
With over 1100 clients and 30+ years of experience in conducting drug development studies.We are proud of our strong track record of regulatory submissions and robust historical control data and therefore feels confident in developingand thoroughly assessing the safety profile of your molecules. As an extension of your team, our scientists and technicians will help enable and expedite your research goals, ensuring that your preclinical drug development program provides quality data for key decision- making.
Clients
Years Experience
Global Regulatory Submissions
Investigational New Drug (IND) packages submitted
- USFDA (US)
- EMA (Europe)
- MHRA (UK)
Global Regulatory Submissions
Investigational New Drug (IND) packages submitted
- EMA (Europe)
- MHRA (UK)
- USFDA (US)
what people ask
Frequently Asked Questions
What biologics testing services do you offer?
We provide end-to-end safety, toxicology, bioanalysis, and specialised testing solutions for biologics.
What types of biologics do you have experience with?
We work with monoclonal antibodies, biosimilars, ADCs, peptides, vaccines, oligonucleotides, and cell & gene therapies.
How do your services ensure regulatory compliance?
Our studies adhere to international guidelines, ensuring high-quality, regulatory-ready data.
What pharmacokinetic services do you offer?
We conduct PK, TK, and biodistribution studies.
Do you support both GLP and non-GLP studies?
Yes, we conduct both GLP and non-GLP studies.
