There are lots of options when it comes to formulation of biologicals. However, the formulation needs to be appropriate for the type of product. This should be driven by the products Target Product Profile (TPP), asking questions such as “what is the required shelf life of this product?” or “what is the temperature that this product will be stored at?” These questions should help drive the type of formulation that is required for the product. While your TPP may require you to store the product in the refrigerator or on the clinic shelves for 2 years – the reality may be that your formulation won’t be able to deliver it. Furthermore it has to be suitable for the patient to allow delivery of the product. It shouldn’t make it difficult to administer by the clinical professional and it certainly shouldn’t pain or other problems for the patient. Formulation is a careful balance of all of these considerations.
GRA has experience in helping organisations select appropriate formulations – whether it’s finding a suitable adjuvant, selecting excipient for lyophilisation, or working with a blue sky technology that promises amazing stability. GRA has worked with formulation partners globally including but not limited to The Macromolecule and Vaccine Stabilization Center, Biopharma Technology, Leukocare Biotechnology, Vaxess Technologies and Novolabs. We have experience of working with clients and partners to help manage the development of formulations for various biological products including live viral vaccines, biotech products that are notorious for inability to be well stabilised. In addition we strongly recommend the use of Quality by Design (QbD) and Design of Experiments (DoE) approaches in the development of formulations.
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