Tepnel Case Studies – Method Development for Peptide Drug Products

Tepnel is a GMP quality assured analytical testing facility, with over 30 years of expertise and knowledge in a wide range of cost-effective services for the whole drug development process.

Our team were recently approached to develop two new methods for peptide drug products, what can sometimes be a challenging task. However, utilising our extensive experience and high-quality testing technology, we were able to provide a series of benefits to our clients.

Now with ICH Q14, there will be a requirement to document the method development approach to ensure a method is fit for the life cycle of the product by highlighting the critical method parameters that require control (CCPs). This is best achieved by using a software package such as the Matrix Fusion AQbD package that we use here at Tepnel.

Choosing Tepnel for method development meant that we could offer the following advantages:
  • Increase efficiency by reducing run time by over 50%
  • Increase separation, with a 5-fold increase in resolution
  • 10-fold increase in sensitivity for detecting impurity leaks
  • Time and cost savings

Click on the video below to listen to our Business Development Manager, Stewart Neithercut discussing the recent case studies and how we supported our client with a service tailored to their specific needs.

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