GMP Transfer And Scale Up

Technical transfer activities include:

• Analytical methods validation to test methods robustness prior to process scale up
• Small scale process validation to test process limits prior to scale up
• Process scale up to reach the expected production capacity
• Analytical methods and USP/DSP technical transfer activities including:
  • Tech transfer protocol
  • Associated tests and reports
  • Detailed process description
  • Process risk analysis and training plan for your production technicians and operators
• Commercial scale process validation for the production and release of DS validation batches at commercial scale in your facility

Make Your Process a Success, Anywhere in the World

When the time comes to scale up your production process, transfer it to a local manufacturing partner for commercial routine production, or move it and build your own facility, our experts will work with you to ease the process and make your program a success.

Transfers need to be performed in an organised, methodical manner with appropriate documentation and within shortest possible timeframe. With you, our local team of experts can develop and execute the process technical transfer plan, ensuring that the overall project will stay within expected timing and lead to a successful outcome.

Our experience implementing and operating a full single use and hybrid GMP processes with our own technologies and products platforms.

De-formulation and characterisation

De-formulation is the analysis of a product where a lab breaks down a material or product to determine the identity and quantity of its components. Sometimes known as “chemical reverse engineering,” this process enables scientists to take a medication and discover the contents of its core and coatings. This is the method necessary to create a generic version of a medication and requires various chemical processes to discover the exact contents of a formula.

Pharmaceutical de-formulation, the reverse engineering of a product’s formulation, is a necessary process to create generic drugs. Even before patent expiration, skilled chemists must perform a detailed analysis to identify, quantify, and characterize the original formula’s active pharmaceutical ingredients (APIs) and its excipients, whether it’s a drug or supplement.

Successful generics companies are the first to market after patent expiration, bringing bioequivalent products to pharmacies as quickly as possible. They achieve this through having solid reverse engineering programs and by utilising outside labs when necessary to help in the process.