Transferring knowledge the world over
The goal of technology transfer activities is to transfer product and process knowledge from development and GMP clinical production to support early through to later phase studies.
Technical transfer activities include:
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.
Placebo matching is a key aspect of pharmacological research, and we offer extensive, rapid and cost-effective services in the field of placebo manufacturing. We fully understand that if you are looking for a placebo to parallel your product, or designing a trial dose that matches an existing comparator, getting a good match can be challenging.
Sponsors require an end-to-end service that can provide comparator products on a global scale.
At Eramol we understand the importance of primary and secondary packaging for your Study design. We know your patients need effective and safe packaging that is easy to use and understand.