Bio - Analytical Services
Our Bioanalytical department has been providing high-quality support to clients since our inception, covering **method development, validation, sample analysis, reporting, and submission** for clinical and preclinical trials.
Our dedicated and knowledgeable scientists are well-trained in **GLP and GCP regulations**, ensuring the highest quality data. All procedures comply with applicable regulatory guidelines including **USFDA, WHO, ANVISA, NPRA, and EMA**.
The team utilizes state-of-the-art instruments, such as **LC-MS/MS, UPLC, HPLC, ICP-MS, and Ion-Chromatography**, to complete projects with uncompromising data integrity.
Core Bioanalytical Services
LC-MS/MS Bioanalysis State-of-the-art Liquid Chromatography–Mass Spectrometry (LC-MS/MS) for accurate, sensitive quantification of drugs and metabolites in biological matrices (plasma, urine, tissue samples). This advanced technology ensures the highest level of data precision for small molecules and biologics.
Biosimilar Testing Specialized testing for biosimilars, ensuring that these biologic products are highly similar to their reference biologics in terms of pharmacokinetics (PK), efficacy, and immunogenicity. Our bioanalytical services comply with FDA, EMA, and ICH guidelines for biosimilar approval.
Large Molecule Bioanalysis Advanced testing for large molecules (e.g., monoclonal antibodies, therapeutic proteins, peptides) using techniques like LC-MS/MS and ELISA. These services support the development of biologics and help assess pharmacokinetics, immunogenicity, and drug concentrations in biological matrices.
Method Development & Validation Custom development and validation of bioanalytical methods for small and large molecules, ensuring they meet stringent regulatory guidelines (FDA, EMA, ICH). We provide reliable, reproducible, and accurate results.
Pharmacokinetics (PK) & Bioavailability Studies In-depth analysis of drug absorption, distribution, metabolism, and excretion (ADME) to support clinical trials, bioequivalence studies, and regulatory submissions. These studies provide essential data for dose optimization and drug efficacy.
Toxicokinetics & Safety Testing Comprehensive toxicokinetic studies to assess the safety of investigational drugs. This includes dose escalation studies, toxicity testing, and determining safe dose ranges for clinical trials.
Immunogenicity Testing Detection and characterization of immune responses to biologics and therapeutic proteins. This ensures that biologics and biosimilars do not provoke adverse immune reactions, crucial for the safety profile of your products.
Sample Storage & Archival Secure, long-term storage of clinical samples in compliance with regulatory standards. We ensure proper traceability, integrity, and preservation of all biological samples throughout the trial lifecycle.
Specialized Capabilities
- Method development and validation for a wide spectrum of drug substances.
- Quantitative analysis at picogram /mL concentration.
- Chiral Molecule Analysis.
- Complex bioanalysis of bound and total drug.
- Bioanalysis of conjugated and total drug (By enzymatic process).
- Hormones and Vitamin analysis.
- Invitro Dissolution study.
- Invitro permeability assay using Caco-2 Cell line (BCS-Bio waiver study).
- Bio Analytical methods for biosimilars including mAbs (Large molecule).
- Expertise in conducting Phosphate Binding Studies (e.g., Sucroferric oxy hydroxide and Ferric Citrate).
Infrastructure
| INSTRUMENTS SPECIFICATION | NO. OF INSTRUMENTS |
|---|---|
| LC-MS/MS (Waters Xevo TQMS, Quattro Micro Mass, API 5500, 4000 & 3200) | 19 |
| ICPMS | 1 |
| GC-MS/HS | 1 |
| HPLC | 2 |
| DEEP FREEZERS (-20°C) | 2 |
| DEEP FREEZERS (-30°C) | 5 |
| DEEP FREEZER (-40°C) | 3 |
| DEEP FREEZERS (-80°C) | 9 |
Operational Capabilities
- 230+ validated methods (including assays as low as 1pg /mL) and approx 2-3 new methods validated every month.
- Method development/validation for proprietary (NCE) and non-proprietary assays.
- Method transfer or cross validation between global sites, instruments, species & matrices.
- Methods for drug-drug interaction studies.
- Bioanalysis of drug and metabolites in a variety of biological matrices from preclinical and clinical trials.
- Ability to develop and validate highly sensitive assays in low pg/mL range.
- Ability to develop and validate methods well in advance based on patent expiry and business sense.
- Ability to accommodate projects with rapid turn-around-times.
- Qualified, trained & experienced team of bioanalytical professionals.
- Validated Methods