Custom Pharma Services goes Back to the Future!

Whilst investing in modern technologies, Custom Pharma Services is using our decades of experience and expertise in the lifecycle management of niche and difficult to manufacture medicines to accelerate the development of new and novel medicines for our clients.

Whilst investing in modern technologies, Custom Pharma Services is using our decades of experience and expertise in the lifecycle management of niche and difficult-to-manufacture medicines to accelerate the development of new and novel medicines for our clients.

If you would like to find out more read on and come and visit our Team at CPHI in Barcelona, stand 80D49.

Over the past 40 years, Custom Pharma Services has seen most, if not all, of the challenges associated with the manufacture of oral solid dose products.  And despite the advent of Quality by Design (QbD), where these potential risks would be evaluated and mitigated during development; when you specialise in older, niche products that were developed before QbD became commonplace the product development knowledge is often limited.  This often results in significant challenges with the manufacturing process remaining and when these risks are poorly understood it is inevitable that at some point they will occur.  Managing product and process risk during routine commercial manufacture can be costly and potentially risk the reliability of the supply chain as they often result in manufacturing deviations or laboratory investigations.

At Custom Pharma Services we are using our real-world knowledge, gained during product technology transfer, routine manufacturing, and through our annual product quality reviews to inform our product development programs.  We build this knowledge into our technical risk assessments where we use the industry standard Failure Mode Effect Analysis (FMEA) methodology.  To be able to fully assess the technical risks during product development you need to know: what might go wrong, the impact of that failure, the likelihood of it happening, and how easy it is to detect this issue.  We are all good at identifying risks, but it is a lot harder to quantify them in a meaningful way, and the occurrence and detection are often subjective.  Through our experience, we have a good understanding of how easy the failures are to detect and how often they occur. Real-world data trumps perceptions and gut feelings.

After assessing the risks, mitigation requires carefully considered experimentation and high-value data. Large-scale experimentation using statistical approaches, such as design of experiments, can be costly in terms of time and materials, especially when there is a finite source of valuable API available during development.  To ensure that we can add maximum value with minimal API requirements CPS has a range of modern technologies to generate high-value data.  These include:

·       Material characterisation techniques, such as DSC, TGA, DVS, and particle size to assess API and formulation properties to determine the right formulation and manufacturing approach to take forward,

·       Compaction and compressibility evaluation using our state-of-the-art StylONE Evo compaction simulator and

·       Accelerated Stability Assessment Program (ASAP), used to gain a fundamental understanding of the product stability that can predict future product shelf life and determine the impact of different packaging configurations, all without formal ICH stability studies.

Using our prior knowledge and our modern technologies we can ensure that development programs are focused and data-rich thus reducing the potential for future issues during both product development and routine commercial manufacture.  It is our ability to focus on clinical and commercial that provides added value at any stage of the product lifecycle.

Custom Pharma Services can help you, so regardless of the development phase of your molecule come and meet us at CPHI in Barcelona, stand 80D49 and see how Custom can add value to you.