ADVITY Research is an Independent Clinical Research Organization.

PK/PD Analysis
Ligand Binding Assays
Chromatography Assays
State Of The Art Facilities

ADVITY provides quality services for pharmacokinetic, immunogenicity, and large molecule analysis, leveraging a diverse array of platforms for both small and large molecule analysis. Our bioanalytical procedures adhere to GLP requirements, and we foster cross-functional team collaboration to ensure the swift analysis of time-critical samples.

PK/PD Analysis

Ligand Binding Assays

Analysis of biological samples for drug, metabolite, concentrations and/or immune response.
Development, Validation and sample analysis of PK/PD/Immunogenicity assay for Biosimilars and Biologics
Immunochemistry ELISA, MSD® platform for PK, anti-drug antibody (ADA)

Chromatography

PK sample analysis
Pre clinical PK sample analysis
Bioanalysis of first in human PK sample analysis
High and low sensitive molecule analysis

Ligand Binding Assays – Challenges Accepted

Our team is proficient in MSD SQ 120 and SpectraMax M5, ensuring high-precision analysis and reliable results.

Our team comprises individuals with over 15 years of experience in method development and validation of complex large molecule for various regulatory markets.

We consistently invest in resources such as new technologies and instruments to stay abreast of ongoing market demands.

Ligand Binding Assays: Pharmacokinetic & Immunogenicity Assays on ELISA…

Proficiency in PK, quantification of biological drugs, and ADA assessment.

We have a comprehensive grasp of regulatory prerequisites and a track record of method development aligned with FDA, EMA, and ICH standards.

Chromatography - Challenges Accepted

Continuous investment in new technologies and instruments
Expertise in small and large molecule quantification
Extensive innovator expertise including chiral separations
Development of complex chromatography evaluating ultrasensitive methods
Experience on 800+ assays with 50+ years of combined experience from the top Method Development scientists
Recognized industry leader in the development of methods validated to meet current regulatory standards (FDA, EMA, ICH).

State-Of-The-Art Facilities

A state-of-the-art facility spanning approximately 42,000 sq. ft., well-connected to all major parts of the city.
Comprehensive emergency infrastructure to ensure the safety and emergency handling of participants.
A volunteer cross-participation verification system to ensure right participants take part in the study.
In-house developed eDC tool for seamless data capture without integrity issues.
Clinical pharmacology units with bed capacity to accommodate 10,000 doses per year.
Additional clinical pharmacology units under development to accommodate an additional 8,000 doses per year.

State-of-the-art Intensive Care Unit with modern infrastructure to handle basic emergency requirements during clinical studies.
A In-house X-ray and ECG facilities.
Partnership with a tertiary care hospital for emergency handling.
Association with NABL accredited path labs to select the right participants for the study.
Humidity chambers for the storage of investigational products.
Archival facility with sufficient space for future expansion.
State-of-the-art bioanalytical facility with advanced analytical infrastructure.

Advanced LC-MS/MS systems to accommodate bioanalytical methods up to 1 pg/ml.
Deep freezers to store extended volumes of biological samples.
State-of-the-art large molecule analytical facility – ELISA.
Eurotherms installed across the analytical facility to monitor temperatures.
Cutting-edge IT infrastructure with SonicWall firewalls, Dell servers with RAID-5 configuration, NAS storage with RAID-5, and Kaspersky Antivirus for robust security.
SAS version 9.4 system fully validated.

Reach our Director Bioanalytical to know more about our analytical capabilities

Services

Bioanalytical Services