Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Epistem’s Biomarker Division Gains GCLP Accreditation

By Pharmaceutical Processing | June 7, 2010

Epistem plc announced today that their Biomarker Division has been awarded Good Clinical Laboratory Practice (GCLP) accreditation status. The Biomarker Division conducts gene expression analysis to support clinical drug development programs within pharmaceutical and biotechnology organisations, with an increasing focus on providing valuable biomarker information that can be used in diagnostic applications. 

For use in tissue and sample preparation, Epistem has developed a proprietary cDNA amplification technique which enables gene expression information to be provided from very small (or degraded) biological samples such as formalin-fixed, paraffin-embedded (FFPE) tissue, laser captured microdissected (LCM) samples, single plucked hairs, fractionated blood cells and pinch biopsies.  Epistem also provides ‘off the shelf’ and proprietary panels of biomarkers targeting known oncology and disease specific biological pathways.  Epistem has pioneered a technique to provide and interpret gene expression information from single plucked hairs, working with drug development companies globally to support biomarker programmes which translate from preclinical proof of concept to clinical phases.  

GCLP accreditation now enables Epistem to support the later stage clinical phases of drug development assuring customers that all studies will be conducted to GCLP quality standards set by the British Association of Research Quality Assurance.  GCLP status demonstrates that the Biomarker Division operates to a standard that assures the reliability, quality and integrity of the work and results generated.

Lydia Meyer-Turkson, Vice President of the Biomarker Division commented, “Accreditation strengthens our clinical biomarker capabilities enabling us to support regulatory submissions from partners who use our technology and expertise globally”

Related Articles Read More >

Driving success in fast-paced high-tech pharma construction projects
This is a photo of the Fujifilm Diosynth Biotechnologies plant under construction in Holly Springs, North Carolina.
Fujifilm, Regeneron ink $3B U.S. manufacturing agreement
This is the logo of Johnson & Johnson.
J&J breaks ground on $2B manufacturing facility in North Carolina
sherwin-williams-pharma-facility (1)
Sherwin-Williams expands flooring solutions for pharma facilities
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE