Our advanced therapy clients face the challenge of successfully developing and manufacturing medicinal products from patient or donor cells. Such products need to show good safety, consistent quality and clinical efficacy while meeting market demands with a competitive selling price.
We can help you in the assessment of your current manufacturing process to identify possible improvements and define a process development strategy appropriate to your stage of development. We also offer the opportunity to perform process development work in our state of the art facility in Bristol. We facilitate the definition of the development program and comparability analysis with prioritisation based on risk and cost analysis of the process, from early clinical to commercialisation.
As the manufacturing process needs to be robust, reproducible and suitable to meet commercial market demands, this requires:
- Knowledge of the product and process including a target product profile and knowledge of the process’ design space
- A documented process development program with proof that process changes do not impact product safety, quality or effectiveness
- Cost of Goods (CoG) analysis of current and adapted process and business impact
- A manufacturing strategy that fits with the need to supply different geographic locations and assure worldwide supply.
In close collaboration with our clients, we can perform an FMEA or gap analysis, to identify and value the problems and the solutions. This enables our clients to define the process development options to mitigate risks.
When working towards later stage clinical development and commercial manufacture, we can perform cause and effect analyses to determine process variability and identify criticality in process parameters and quality attributes. Such analysis helps to define the product specifications as well as a process characterisation profile which facilitates trending of the manufacturing process. This approach will enable you to effectively improve your production process to have a consistent and (cost) effective manufacture of your product.