Nowadays, it is fairly common to differentiate projects by their complexity. As the term suggests, “exclusive synthesis” means that most of the chemicals produced are generally manufactured on an exclusive basis. There is a one-to-one relationship between the customer and the producer and the product is only applicable to a specific project. When the project dies, the product will no longer be of any commercial value. Molecules with less-elaborate structures might have a chance to be utilized in different products as advanced intermediates, while some of still lower complexity might be used as basic starting materials.
In addition, there exist three distinct types of projects that differ on a more general basis, namely
114 von Hippel r custom manufacturing projects,
r contract manufacturing projects, and r toll manufacturing projects.
Custom manufacturing projects are projects where the customer typically
has a molecule just emerging from research and perhaps a first idea of how to synthesize it but no more information. For such a project, usually no technical information is available, and therefore the only information to share might be the structure or a chemical abstracts service (CAS) number. It is part of the project partner’s job to develop a synthetic route, including all the in-process controls required, and sometimes even to develop an analytical method for the final product. Both customer and supplier will work together to find a workable specification and to fulfill all requirements from the authorities. The full range of support is required and, ideally, all functions should be in-house at the selected partner’s site.
The best partner for such a development will be a company able to offer the full range of technologies needed, including the strongest analytical support. To have these technologies available not only on paper but also in reality, such a company should have a minimum size. Without this critical mass, a company is unlikely to have the financial and organizational power to have all relevant analytical equipment in place and might not be the best partner in terms of broad access to creativity to offer best solutions to the customer’s needs. This type of company might also have the power to have a worldwide network of suppliers for raw materials and the power to direct them. Such a company might also have most types of the production equipment in-house leading to high flexibility in terms of realizable processes.
On the other hand, such a company might also have its limitations. For high-throughput screening substances, just a few milligrams are needed, so these companies might not be the best choice. Instead, there are smaller companies available, typically headed by a chemist with strong experimental skills, that are able to make small amounts of products in a short time. To focus on such a type of synthetic work needs other skills than those for production-orientated processes.
Contract manufacturing means the customer will be in the position to share a
more or less detailed process with his potential supplier. The information available right from the initial project evaluation is more specific and therefore the need to protect the customer’s interests will be even higher. For both parties it is easier to understand whether the process will fit into the potential supplier’s production equipment and how the commercial production will look. On the other hand, there will still be a lot of open questions about how to adapt the existing process to the supplier’s equipment and how to run the campaigns best.
The creative part of route design in these cases is more limited, but fre- quently there are still a lot of questions to be answered and such projects are still demanding. The transfer of knowledge from one company to the other is partic- ularly important, and again, the nature of the interaction between the companies determines the level of success.
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Toll manufacturing is the last type of project. Here the project sponsor not
only provides the detailed process but also some of the key raw materials. This will be very interesting for both parties in the event that special technologies are requested and both companies in combination can offer an advantage that they do not have independently. This is the most extreme level of cooperation at the other end of the scale: While custom manufacturing requires a spirit of invention, toll manufacturing takes advantage of special technologies and the availability to run them.
For the responsible project managers of the two companies, the job is again more difficult than in the case of pure contract manufacturing: Even more functions of the two companies have to work together and interact to make the project a full success. Depending of the regulatory status of the product—non-GMP [not fol- lowing good manufacturing practices (GMP)], c-GMP [current GMP], registered intermediate, or API—the complexity grows. Only open communication and a per- manent comparison of the expectations of the two development partners allows both parties to optimize and reach a level they could not achieve independently. ORGANIZATIONAL CONSEQUENCES AND