The Solution Providers

Custom synthesis means the exclusive synthesis of compounds on behalf of the customer, on the scale, with the purity and with the specification or methods required. There is a big difference between the conditions used for small-scale custom synthesis of entirely new molecules and those used for standard multi ton per annum manufacturing, just as strictly regulated cGMP syntheses are different from those performed for R&D purposes.
In the market of custom synthesis services, there are different kinds of service providers, which when properly selected, can give the best solutions for any project.
A Contract Research Organization (CRO) enables the outsourcing of a broad variety of research activities from custom synthesis of small molecules to clinical trials of a new drug, which helps to enliven the commercial research culture toward an international, innovation-based drug industry.
CROs, with their new epistemic skills and capacities, are both manifestations of the changes in commercial research cultures as well as the vehicles to achieve them.
In contrast to a Contract Manufacturing Organizations (CMO), which produces ten to thousands of tons of fine chemicals on multi-purpose plants, CROs have a lab bench or patient population as their working base. However there is an interface when it comes to the pilot plant, which is needed at a certain stage in both industries.
When discussing CROs, it is important to distinguish between their “medicinal” and “chemical” sub-types (mCRO/ cCRO), since they address different scopes of the value chain toward a new life science product. mCROs are active in the clinical part of drug development, operating in the sphere of physicians, hospitals, and patients, but also dealing with medical devices, diagnostics, and drug administration. Conversely, cCROs mainly focus on only two aspects of the value chain, namely the small-scale preparation of active ingredients of new drugs and the design and basic development of the manufacturing process. As a result, mCROs attract more attention, and the general public considers the outsourcing of pharmaceutical development to predominantly include tasks such as lead identification, compound screening, lead
optimization, or clinical trials. Therefore, the market for contract businesses offering custom synthesis and research services is rather small compared to that of mCROs.
Apart from pure cCROs and pure CMOs, a number of hybrid companies known as Contract Researching and Manufacturing (CRAMs) organizations also exist, offering both chemical contract research and contract manufacturing on scales from mg to tons. The advantage of these big one-stop shops is questionable, since small-sample orders only rarely evolve to industrial scale-up supply (in more than 90% of the cases, projects are terminated at the lab sample stage), implying that true synergies are rare.
Thus, although relying on one CRAM organization may benefit a strong partnership throughout the overall value process, it does not have the same character as the selection of individual highly efficient partners entirely focused on one core business. Such specialized partners not provide only resources but also real scientific/technological input. Custom Synthesis and Contract Research companies are often part of cooperative activities to react to such customer demands. Networks are able to provide both complementary and customized offerings, sharing resources, information, and experience and therefore acting like a “virtual” one-stop shop.
Here, the definition and constitution of efficient and effective intersections between these partners is the key to success. The main competence of cCROs is small-scale synthesis of non-commercially available compounds on an exclusive basis, commonly named Custom Synthesis and Contract Research. The background and the purpose/stage of product development are of (nearly) no importance when searching for a new synthetic route toward a (new) molecule, lead compound, impurity, API, metabolite, or any other compound.
The smaller working scale of cCROs compared to that of CMOs is a conceptual limitation of such entities. In addition to the mere delivery of an exclusively made compound, the outline, optimization, process development and “ReDesign” of a synthetic route is also part of the Custom Synthesis and Contract Research business, which comprises entirely new syntheses as well as already established synthetic routes in need of improvement for any reason. In the past, entry barriers for setting up a custom synthesis company were low, for example, the history of most companies began with individual chemists (often PhD students), occasionally working on their own, preparing samples for pharma companies (“garage companies”). As the scale of these activities increased, fellow students were hired to allow for expansion.
Today, such an approach is hardly possible in view of the tighter regulations, higher complexity of molecules, and the elevated quality expectations of customers. Today, customers require higher standards of know-how, experiences, infrastructure, quality management systems, safety assessments, and available technologies. On top of that, a track record, references in the industry, seamless and proven intersections to horizontal and vertical partners are mandatory for being able to meet the expectations and requirements in this industry.