Services for in vitro Pyrogen Testing

Set up the in vitro Monocyte Activation Test (MAT) in Your Lab

Discover our services portfolio supporting the PyroMAT™ kit for pyrogen detection

Pyrogen testing in the pharmaceutical industry is a highly regulated and complex field. In our long history of serving the pharmaceutical industry by pioneering and refining ground-breaking solutions, we have gained the regulatory and technological expertise to offer our customers a comprehensive range of professional, best-in-class services so you can ensure the safety of parenteral pharmaceutical products and medical devices.

BioM Pharma services – Pyrogen testing visual - method life cycle

 

PyroMAT™ application services

Pyrogen testing method for an easy validation and cost-effective testingOptimize or simplify your pyrogen testing method for an easy validation and cost-effective testing

Your benefits:

  • A name you know
  • People you can trust
  • Methods you can validate
  • Ready when you need us

Feasibility study

An experimental study carried out in our application laboratory using your samples to assess the compatibility with the PyroMAT™ system using the short ELISA protocol and the Gen5™ software protocol.

Method development

An experimental study is carried out in our application laboratory using your samples. Assessment of the product compatibility with the PyroMAT™ system using the long ELISA protocol and the Gen5 software protocol. Development of an appropriate method to overcome interference.

Software data analysis service for routine pyrogen testing

Consulting service to support with the analysis of the raw data from a routine test generated at customer site using the PyroMAT™ system. Detailed analysis and interpretation of raw data using the Gen5 software protocol. Available for all MAT test methods (Methods A, B or C acc. to Ph. Eur. 2.6.30). Calculation of Endotoxin Standard Curve, Maximum Valid Dilution (MVD) and pyrogenicity level of the tested product based on the Contaminant Limit Concentration (CLC).

PyroMAT™ validation services

Get ready to start using your new in vitro kit to detect both endotoxin and non-endotoxin pyrogens within a few weeks!

Your benefits:

  • Proven protocols and expertise to qualify your pyrogen detection assay
  • Streamline the method validation process
  • Reduce the development time & cost of the validation

Product specific validation consultancy service

Product Specific Validation consultancy to ensure compliance with EP using the PyroMAT™ system based on the method targeted for routine use:

  • On-site theoretical and hands-on training and PyroMAT™ system demo
  • Customized pyrogen testing protocol
  • Guidelines for further tests
  • Phone and e-mail support: follow-up of tests, analysis of data, interpretation of results, planning of next tests, practical recommendations, technical guidance, tips and tricks, sharing of our knowledge and expertise of the PyroMAT™ system

Software data analysis services for product specific validation

Consulting service to support with the analysis of the raw data generated at by the customer site during the Product Specific Validation with the PyroMAT™ system:

  • Agreement with customer on the target Contaminant Limit Concentration (CLC) and the chosen method
  • Detailed plate setup to be followed during Product Specific Validation to be sent upfront
  • Calculation of the Maximum Valid Dilution (MVD)
  • Detailed analysis and interpretation of raw data using the Gen5™ software protocol

Product specific validation execution service1

On-site or in-house theoretical and practical training on the PyroMAT™ system, including assessment of the different parameters to verify during the Product Specific Validation execution:

  • Execution of the Product Specific Validation in-house on 3 product lots
  • Customized test protocol
  • Method transfer support

PyroMAT™ training services

Ensure your lab team feels comfortable using PyroMAT™ System

Pyrogen testing school1

Theoretical session of pyrogen testing using MAT technology:

  • Overview of current endotoxin and pyrogen testing methods
  • Testing of non-endotoxin pyrogens
  • Overview and requirements of regulations focusing on Monocyte Activation Test (EP 9.2, chapter 2.6.30)
  • Validation of the PyroMAT™ System
  • Overview of the PyroMAT™ System portfolio
  • Overview of the PyroMAT™ System procedure
  • Introduction of the Gen5 software protocol: data analysis, calculation of MVD (Maximum Valid Dilution), CLC (Contaminant Limit Concentration), examples

Practical session:

  • Execution of a complete test according to the quantitative method (method A)
  • Incubation with PyroMAT™ cells: set-up of plate, tips & tricks, pipetting schemes
  • Interleukin-6 ELISA: transfer of an incubation plate set-up (incubated the day before), addition of conjugate, substrates and reading
  • Data analysis: analysis of the raw data generated using the Gen5 software protocol

You will find below our face-to-face training offerings. We also have a brand new range of remote solutions like e-learning, remote schools and remote validation consultancies. For more information, please visit our dedicated page.

Pyrogen Testing Remote School

You will find here our face-to-face training offerings. We also have a brand new range of remote solutions like e-learnings, remote schools and remote validation consultancies. For more information, please visit our dedicated page

PyroMAT™ advanced operator training1

This course includes the theoretical aspects and an interactive workshop in addition to a hands-on session on the best practices of use of the PyroMAT™ System. A training certificate is delivered to each participant after evaluation.

BEST and on-site BEST microbiology training2

BEST is a 3-day innovative, interactive educational program designed specifically for you. This program will focus on both in-process and product release quality control, including bioburden, endotoxin, and sterility testing, and environmental monitoring. The training will provide an overview of relevant methods in each area; however, basic technical laboratory skills are assumed as a prerequisite for participation. The course will consist of class presentations and demonstrations of laboratory applications.

  • Understand the current requirements of pharmacopoeias and be familiar with good testing procedures from method development / validation through to routine test result interpretation
  • Take preventive actions to avoid false positive or false negative test results
  • Develop and optimize testing procedures
  • Understand and identify root causes for common issues
  • Hands-on training

Learn more about our BEST QC Microbiology Training

1 Not available in North America

2 Available in North America only