Custom synthesis outsourcing in the pharmaceutical and life science industry in early stage pharmaceutical development offers several advantages. By entrusting outsource partners to handle customs synthesis of API’s, intermediates or several steps in a synthetic route, a pharma company or CRO can reduce the uncertainties in cost and timescale that process development R&D often causes and instead share the risks and rewards with their outsource partner.
Pharmaceutical product/process development often involves large amounts of custom synthesis R&D to take a small scale lab developed route up to a sufficient scale to produce enough API for use in clinical trials.
From the identification of a drug candidate through to small scale lab synthesis and onto kilo-scale synthesis, a proposed synthetic route can change significantly due to a number of factors. One of the key factors is economic viability to ensure that once mature, a manufacturing route will meet cost criteria and ensure the final product is economically viable. Changes in the synthetic route and intermediates leads to more R&D, new intermediates and more process development costs.
Pharma outsourcing all or part of a custom synthesis project allows a company to take better control of their R&D related variable costs and increase the efficiency of their product development. This approach also allows company's to place certain projects with a partner with a stronger specialism in the required area.
Pharma outsourcing also allows a company with their own finite custom synthesis resources to prioritise which products they keep in-house in order to maximise profit/minimise costs and to make the most efficient use of their in-house capacity.
Organic chemistry is a broad field with many different techniques and disciplines. Different companies have strengths in different branches of synthesis. Leveraging the abilities of an outsource synthesis/development partner with a broad knowledge and deeper experience can not only help to reduce R&D costs over the traditional in-house model of synthesis but can help to accelerate the development of a product to market.