Siteclabs

Siteclabs

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Analytical Method Development and Validation

A fully GLP compliant and state-of-the-art Bio-analytical Facility with the area about 12,500 sq. ft. LC-MS/MS instruments (12 systems) that provide the flexibility to develop and execute analysis in wide range of sensitivities (µg/ml to pg/ml).

LC-MS/MS Instrumentation:

  • Agilent HPLCs coupled to Sciex API 2000, API 3000 (2 systems) and API 4000 (2 systems).
  • Agilent HPLC coupled to Sciex API 4000 Q-Trap system.
  • Shimadzu HPLC couple to Sciex API 3200 system.
  • Water UPLC with Quatro Premier XE MS/MS (2 System).
  • Agilent RRLC and Shimadzu UFLC coupled to Sciex API 5500 (2 systems).
  • Shimadzu UFLC coupled to Sciex API 5500 Q-Trap.

Sample Processing Facilities:

  • Ultra sensitive balances with least count up to 0.1 µg.
  • Cooling centrifuges accommodating sample tubes in different formats.
  • Sample concentrators accommodating sample tubes in different formats and 96 well plates.
  • Dedicated refrigerators and freezer for storage of reference substances and stock solutions.
  • Dedicated lab space for execution of very sensitive and light sensitive assays.
  • A Robotic Liquid Handling System (EVO 200) from Tecan for high throughput sample processing.

Sample Storage Facility:

  • Eleven deep freezers with cooling up to -80° C.
  • Temperature monitoring performed using state of the art wireless data logging and excursion alarm system.

Analytical Method Development and Validation

  • A fully GCP compliant bio-clinical centre occupies a spacious modern building over 10,000 sq. ft. of area.
  • 60 bed Clinical Unit consisting of 2 independent access controlled clinics of 30 beds each.
  • Large data base of eligible volunteers including healthy male / female and special population e.g. Post menopausal women.
  • Central monitoring by CC TV of all Clinical Pharmacological Unit.
  • Dedicated Sample Collection / Processing area.
  • Sample Storage facility comprises up to -80° C conditions Deep Freezers which are constantly monitored by automated system.
  • Well equipped pharmacy with walk-in humidity chamber which are constantly monitored by automated system
  • Statistical Services using validated latest versions of advanced statistical software like WinNonlin and SAS
  • Well equipped one bed Intensive Care Unit and contract with nearby super specialty Hospital.
  • Cafeteria with hygienic condition
  • In-house pathology lab (NABL Accreditation in process)
  • Detailed SOPs dealing with various study related activities, data acquisition, processing and archival