Bioanalytical METHOD DEVELOPMENT AND VALIDATION

The Analytical Chemistry Division at IITRI provides unique services such as active pharmaceutical ingredient (commonly known as test article) formulation development, dose range finding, dose formulation analysis, and bioanalytical services for small and large molecule therapeutics.

Pre-clinical Studies

The analytical team at IITRI is fully dedicated to performing analytical method development and validation for pre-clinical evaluation of small molecule or biologics drug substances or drug products. We use comprehensive and fit for purpose analytical procedures fully compliant with FDA guidelines for analytical method transfer, method development and validation from scratch followed by validation to meet our client’s requirements.  The development and validation team has a dedicated team of scientists with over 20+ years of experience in ICH and FDA guidelines. The team has extensive experience developing and validating bioanalytical methods for various classes of APIs, excipients, preservatives, intermediates and finished pharmaceutical products.

Discovery Stage Studies

IITRI also offers discovery stage bioanalytical services in order to help our clients make quick decisions on their potential drug candidate/s. The discovery services enable optimization of leads and greatly improves the chances of success while significantly cutting down unnecessary costs and cycle time. Our program is designed to help you advance your most promising drug candidate with high confidence in the final outcome.

Instrumentation Capabilities

The Analytical Chemistry Division laboratories are GLP-certified with dedicated instrumentation for the development of robust analytical procedures. The analytical laboratory possesses several equipment’s and few of them are listed below:

• LC/MS
  1. AB SCIEX 6500 Q Trap coupled with Waters UPLC Acquity H class plus
  2. AB SCIEX 5500 Triple Quad coupled with Sciex Exion AC20 LC or Shimadzu 30-series LC
  3. AB SCIEX 4000 Q Trap coupled with Agilent 1200 LC

• Waters and Agilent HPLC and UHPLC with different detectors: Variable wavelength (VWD), diode array (DAD), refraction index (RI)
• UV/VIS spectrophotometer
• Bruker FT-IR
• GC-Flame ionization detector (FID)
• GC-MS
• Karl Fisher Titrator (Water Content Analysis)
• Dissolution testing
• N₂ Generator
• DI water systems
• PE – Liquid Scintillation Counter – Tri-Carb 2200
• PE – Automatic Gamma Counter – 1470 Wizard
• Astoria Pacific – Constant Flow Analyzer
• Integra Mini 96 Pipet Automatic System

The IITRI Advantage

• Highly experienced bioanalytical team with greater than 60% of the scientists holding advanced degrees
• Expertise in GLP ELISA method development and validation
• Smooth transfer of methods and data to/from central lab of choice

Download Bioanalytical Services Brochure