GLP hERG Screening at Metrion Biosciences Background
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Discover the potential of GLP hERG Screening

Receive expert guidance from our dedicated team of Ion Channel Experts throughout your programme. Giving you, not only, the accurate and efficient study-related data you need in real time, but also interpretation, insight and advice to support your cardiac safety programme.

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Learn more about GLP hERG Screening

As an industry-leading CRO in Ion Channel Screening, Metrion Biosciences provides screening services against hERG using whole-cell patch-clamp electrophysiology. Our GLP hERG Screening Services have been audited and approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and are performed in accordance with the FDA best-practice guidelines. We offer high-quality, cost-effective compound screening for all your cardiac safety screening needs.

Choosing a partner

As a dedicated ion channel CRO, Metrion has extensive experience of providing high-quality biology services for ion channel targets. We are able to do this in a cost-effective and timely manner that dovetails with your own drug discovery timelines.

Our team offers:

  • Exceptional ion channel electrophysiology and drug discovery expertise
  • A team of experienced cell biologists to create novel cell lines
  • High-quality, cost-effective compound screening
  • Detailed characterisation of lead compounds in a range of high-quality assays
  • Translational services including confirmation of efficacy in stem cell and other phenotypic models 
  • Rapid reporting and data interpretation by highly experienced ion channel scientists
Metrion Bioscience New Head Quarters, Granta Park Cambridge

Metrion is located within the Cambridge bio cluster, one of Europe’s largest bioscience research hubs. Our state-of-the-art laboratories at Granta Park house high-quality facilities for native and engineered cell line and induced pluripotent stem cell culture. We have a comprehensive suite of automated patch clamp platforms, multiple manual patch clamp rigs, fluorescence-based screening capabilities and laboratory data management and reporting systems. 

GLP hERG Screening at Metrion Biosciences

Our clients range from large pharmaceutical companies and established entities within the life sciences industry to smaller specialist businesses, charities, academics and start-ups looking to validate, develop or de-risk ion channel modulators as they progress towards a nomination for clinical development. Find out more about how we can support you today.

Why are GLPs important for hERG safety assessment programmes?

GLP hERG screening is a vital step in the transition from preclinical research to Phase 1 clinical trials in humans, regardless of therapeutic target class. Pharmacological assessments against the human ether-à-go-go related gene (hERG) potassium channel, conducted in compliance with GLP principles and adhering to ICH S7A and ICH S7B guidelines, are an important step in the Investigational New Drug (IND) application process for potential small molecule therapeutics.

GLP sets the standard for planning, performing, monitoring, recording, reporting, and archiving studies, ensuring the utmost quality and integrity of safety test data. In particular GLP:

  • Ensures that a plan and protocol is produced for each study 
  • Provides hERG data that helps regulators trust the data and is required in many jurisdictions
  • Helps ensure that all parts of a study are all properly recorded and reviewed
  • Ensures that data is stored for integrity and all study events and parameters can be accurately reconstructed

Our GLP hERG screening services can also be integrated with Metrion’s comprehensive panel of CiPA compliant assays and additional assays that provide an excellent in vitro evaluation of cardiac risk. Our assays are designed and validated to reliably evaluate the proarrhythmic and cardiotoxic liabilities of your compounds by assessing their effects against a comprehensive panel of cardiac ion channels.

Understanding Metrion’s GLP hERG Assay

Metrion provides screening services against hERG using the conventional whole-cell patch-clamp technique. These services are performed in accordance with the FDA’s best practice guidelines and in compliance with:

1. UK GLP Regulations, SI 1999 No 3106; amendments, SI 2004 No. 994
2. OECD No 1 Principles on Good Laboratory Practice and Monographs. 

The experiments are performed using the FDA’s recommended voltage protocol and experimental solutions at physiological temperature.

Concentration verification via chemical analysis of dosing formulations (Dose Formulation Analysis, DFA) is an obligatory requirement for GLP studies submitted in IND filings and is performed by Metrion’s preferred GLP accredited partner. 

Metrion’s Ion Channel Screening Resource Library

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