Bioanalytical Services
Adgyl Lifesciences provides end-to-end support from early discovery to clinical programs across small molecules, biologics, biosimilars, vaccines, and complex formulations. With over 30 years of extensive expertise, GLP-compliant operations, and advanced analytical platforms, we deliver high-quality, regulatory-compliant bioanalytical services
Our experience & capabilities Include
We support GLP IND-enabling studies and other analytical study packages for FDA, EMEA, MHRA, and other global regulatory submissions. We have successfully completed bioanalytical method development and validation for more than 800 compounds and delivered over 200 IND packages globally. We are equipped with Watson LIMSTM 7.5 for data management, with pharmacokinetic modelling and analysis conducted via Phoenix WinNonlin 8.0.
In addition, we also have the capability to perform bioanalytical quantification of clinical trial samples for analytes and/or metabolites as well as biomarkers across Phase I to Phase III studies. Our team has expertise in developing bioanalytical methods for specialised formulations such as liposomes, complex injectables, plant extracts, and nutraceuticals, as well as for diverse matrices, including plasma, blood, urine, CSF, tissues, and rare matrices.
Small Molecules Bioanalysis
- Sensitive LCMS/MS methods for multi-analytes, metabolites, biomarkers, peptides, chiral compounds, prodrugs, unstable compounds and liposomal formulations
- Elemental qualification by ICP-MS methods
- Lower Limit of Quantification (LLOQ) in pg/mL
Large Molecules Bioanalysis
- PK/TK, ADA and Nab assay development, transfer and validation
- Cell-based assays, bioassays and biomarker assays
- Capability to generate custom polyclonal antibodies and labelled reagents
- Platforms include ELISA, MSD and LC-MS/MS
Clinical Sample Bioanalysis
- Clinical matrices: blood, serum, plasma, urine and tissues
- NCEs, generics and large molecules
- Simultaneous determination of parent drug, active metabolite, prodrug and biomarkers
- Fast 72-hour TAT for exposure-guided dose escalation studies
Expertise encompasses
- Complex biologics including mAbs, fusion proteins, novel biologics, gene therapy products, vaccines, biomarkers, peptides, and enzymes.
- Chiral chromatographic separation and bioanalysis of racemic compounds
- Simultaneous determination of pro-drug & active drug, parent compound and metabolites
- Determination of free, liposome encapsulated, and total drug for liposomal formulations
- Derivatization approaches for poorly ionizable compounds
- Assays for endogenous compounds, nutraceuticals, plant extracts, photo/temperature sensitive compounds
State-of-the-Art Infrastructure
- LC-MS/MS systems (Sciex API 6500+, 5500, 4000; Shimadzu 8060 series)
- ICP-MS systems, MSD QuickPlex, ELISA platforms
- Flow cytometer, RT-PCR, COBAS
- End-to-end digital compliance via Watson LIMS
- Protein characterisation: Maurice, SDS-PAGE, Western blot, Nanodrop
- Controlled storage with -70°ºC & -20°ºC freezers (with data loggers, alarms & 24/7 power backup)
- Fully equipped sample preparation laboratories
In Vitro ADMET capabilities include:
- Sensitive LC-MS/MS methods for multi-analytes, metabolites, biomarkers, peptides, chiral compounds, prodrugs, unstable compounds and liposomal formulations
- Elemental qualification by ICP-MS methods
- Lower Limit of Quantification (LLOQ) in pg/mL
- PK/TK, ADA and NAb assay development, transfer and validation
- Cell-based assays, bioassays and biomarker assays
- Capability to generate custom polyclonal antibodies and labelled reagents
- Platforms include ELISA, MSD and LC-MS/MS
- Clinical matrices: blood, serum, plasma, urine and tissues
- NCEs, generics and large molecules
- Simultaneous determination of parent drug, active metabolite, prodrug and biomarkers
- Fast 72-hour TAT for exposure-guided dose escalation studies
- Complex biologics including mAbs, fusion proteins, novel biologics, gene therapy products, vaccines, biomarkers, peptides, and enzymes.
- Chiral chromatographic separation and bioanalysis of racemic compounds
- Simultaneous determination of pro-drug & active drug, parent compound and metabolites
- Determination of free, liposome encapsulated, and total drug for liposomal formulations
- Derivatisation approaches for poorly ionisable compounds
- Assays for endogenous compounds, nutraceuticals, plant extracts, photo/temperature sensitive compounds
- LC-MS/MS systems (Sciex API 6500+, 5500, 4000; Shimadzu 8060 series)
- ICP-MS systems, MSD QuickPlex, ELISA platforms
- Flow cytometer, RT-PCR, COBAS
- End-to-end digital compliance via Watson LIMS
- Protein characterisation: Maurice, SDS-PAGE, Western blot, Nanodrop
- Controlled storage with -70°C & -20°C freezers (with data loggers, alarms & 24/7 power backup)
- Fully equipped sample preparation laboratories
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 bioanalytical needs.
what people ask
Frequently Asked Questions
Can you manage both discovery and clinical bioanalysis?
Yes, we support programs from early discovery through Phase III clinical studies.
How quickly can you deliver results?
We offer rapid turnaround, including 72-hour support for critical studies.
Do you provide pharmacokinetic (PK) analysis?
Yes, PK modelling and analysis are conducted using Phoenix WinNonlin 8.0, enabling accurate interpretation of study data.
What complex products can you analyse?
Liposomes, biologics, gene therapies, vaccines, nutraceuticals, and challenging molecules.
How do you manage sample storage?
Monitored -20°C/-70°C storage with alarms and 24/7 backup.
