Biologics
We provide end-to-end testing solutions for biologics, supporting product development from early research through commercial release. Our integrated capabilities are designed to ensure precision, compliance, and data reliability at every stage, helping clients meet global regulatory expectations and make confident development decisions.
Our biologics testing platforms cover a wide range of bioassays, bioanalysis and immunogenicity assessments across multiple modalities, including novel biologics, monoclonal antibodies, peptides, proteins, oligonucleotides, cell and gene therapies, and vaccines. We offer in vitro screening services including cell-based and non cell-based assays to evaluate potency, functionality, receptor binding, cytokine release, immunogenicity, immune profiling, and target engagement. We also offer preclinical proof of concept efficacy studies to cater large molecules discovery portfolio and IND-enabling toxicology studies.
Our large molecule immunoanalytics team is equipped with delivering regulated bioanalysis (PK/TK), immunogenicity assessment (ADA, and NAb) services with particular focus on method development, validation and sample analysis as per the regulatory requirement.
In addition, we also cater advanced genomics solutions alongside toxicogenomics, pharmacogenomics, and microbiome analysis. These integrated capabilities deliver robust data to support safety, efficacy, and regulatory submissions throughout biologic development.
Key services include
- Cell-based, non-cell based, functional & receptor binding assays
- ADA, NAb
- Cytokine release & impurity testing
- Regulated bioanalysis- ICHM10/FDA/EMA guidelines
- Customised polyclonal antibody generation, purification and characterisation
- CAR-T, gene therapies, viral vectors & nucleic acids
- WGS, WES, RNA-Seq, pharmacogenomics & gene expression
Adgyl Lifesciences offers following IND enabling studies:
Exploratory studies (Non-GLP)
- Mini Ames
- Mini hERG (hERG screening)
- Dose range finding studies
- CVS function screening in telemetered dogs
Genotoxicity (GLP)
- Ames Test
-
In vitro Chromosomal aberration test in Human
Peripheral Blood Lymphocytes (MUT CHAB/HPBL) - Micronucleus test (MNT) in Mice/Rats
Process Hazard Analysis
- hERG assay
- Modified Irwin Test/Functional Observation Battery in rats (FOB-Rats)
- Pulmonary functions(Rats)
- CVS function assessment using telemetered dogs
Toxicology studies (GLP)
- Maximum Tolerated Dose (MTD) followed by 10 day repeat dose range finding(DRF) in Rat
- 28-Day Repeat dose toxicity study in Rat
- Maximum Tolerated Dose (MTD) followed by 10 day repeat dose range finding(DRF) in Dog
- 28 Day Repeat dose toxicity study Dog
Scientific Partnership
Partnering for Scientific Excellence
Adgyl Lifesciences is committed to ensure
Scientifically rigorous, reproducible and timely study execution.
High‑quality data generation aligned with scientific & regulatory requirements
Seamless end‑to‑end support spanning study design, execution, and data interpretation.
Connect with our expert team today to discuss how we can support your biologics discovery and development needs.
what people ask
Frequently Asked Questions
What types of biologics do you support?
We support a wide range of biologic modalities, novel biologics, including monoclonal antibodies, bispecifics, Antibody-Drug Conjugates (ADCs), fusion proteins, peptides, proteins, cell and gene therapies (e.g., CAR‑T), oligonucleotides (siRNA, antisense oligos), nucleic acids (mRNA and DNA), and vaccines, across different stages of development.
Do you offer customised assay development?
Yes. We provide customised assay development and optimisation tailored to specific product characteristics, mechanisms of action, and regulatory or project requirements.
Can your services support both pharmaceutical and biotechnology companies?
Yes. We work closely with pharmaceutical, biotechnology, and biosimilar developers, offering flexible and scalable solutions to meet diverse program needs.
How flexible are your testing strategies for novel or complex biologics?
Our testing strategies are highly adaptable. Assays can be tailored or newly developed to address novel mechanisms, emerging modalities, or specific regulatory and scientific needs.
Can genomics data be integrated with bioassay and bioanalysis results?
Yes. We integrate genomics and molecular profiling data with bioassay and bioanalysis findings to provide mechanistic insights and a more comprehensive understanding of product performance.
