In the chemical industry, custom synthesis describes the synthesis of non-commercially available molecules exclusively for a specific company. The amount thus produced tends to be small, ranging from a few milligrams to about 10kg or so – the production of larger amounts is usually called contract manufacturing. While the customer defines the quality of the required product, the synthetic route is developed by the custom synthesis provider. In such cases, the key challenge is not carrying out an established production process but rather developing it. Once such a process has been developed, it is far cheaper (possibly up to 90%) to produce more of the same material rather than to produce another material.
Key customers for custom synthesis are pharmaceutical and agrochemical companies often for the purposes of new product development, regulatory compliance or analytical validation. Though the biggest of them have their own teams of synthesis chemists, they may also rely on external support if they temporarily need additional resources or external parties that can reduce their overall costs. Smaller pharma and agro players, particularly start-ups, rely even more on custom synthesis providers as it allows them to avoid the high fixed costs of an internal synthesis team.
Successful custom synthesis companies share a number of capabilities, such as speed, high service level, moderate costs and of course broad chemical knowledge.
Customers expect the requested materials to be provided quickly. A typical timeline is 4-6 weeks after the order has been made. Therefore time pressure on companies in this segment is substantial. As mentioned above, the time consuming part of this work is the development of a suitable process rather than producing the material once the process has been established.
Customers also expect a high service level, which in particular means they want to be well-informed on the progress of their order. Successful providers communicate with their customers about once a week, letting them know about potential issues or just the smooth progress of the work. This allows the customers to integrate the predicted arrival date of the ordered molecule into their own planning.
A key resource for a successful custom synthesis organization is analytical support. Analytical techniques such as NMR, HPLC, MS and IR are utilized in order to understanding if each step of a project is successful; and in order for a project to progress smoothly and effectively, analytical instrumentation and experienced analytical chemists must be readily available. Furthermore, the qualitative and quantitative certification of custom synthesized analytical standards through the above techniques helps to further ensure customer satisfaction.
An important reason for hiring an external custom synthesis provider is cost. Consequently competitive pricing is important for success. Custom synthesis is not cheap, but this can still represent substantial savings compared to employing own dedicated staff.
Finally, a basic requirement is broad chemical knowledge, which also helps to achieve reasonable costs and high speed. Though software is available to assist in finding pathways to specific molecules, it still takes expertise to prioritize these pathways in order to increase the chance of success. Due to the broad variety of molecules ordered, custom synthesis providers are required to be specialists in many aspects of chemical synthesis. Specialization is required in areas such as process development, scale up, knowledge of esoteric synthesis techniques and an understanding in the application of the molecules (e.g. R&D versus use as pharmaceutical impurity). Companies also benefit from knowing about chemical trends, e.g., the focus of pharmaceutical research on specific types of molecules.