Your eyes and hands in India · Est. 2019 · Replies within one working day

What is custom synthesis, and how do I protect my process?

Custom synthesis is a plant making a molecule to your specification, often developing the route itself. Protect your process with an NDA, clear IP terms, staged disclosure and audits.

· 3 min read · Creston & Co

Custom synthesis is when a plant makes a specific molecule for you, to your specification, often developing or adapting the route itself. You buy the product. Protecting your process means controlling what you disclose, who owns what is developed, and what the plant may do with it afterwards.

It differs from toll manufacturing, where you usually supply the process and raw materials and pay a conversion fee.

How custom synthesis usually runs

  • You share the target structure, specification and expected volume under a non-disclosure agreement.
  • The plant proposes a route and a development plan.
  • It makes lab-scale and then pilot quantities for your evaluation.
  • It scales up to commercial batches once you approve the product.
  • You agree supply terms for regular orders.

What you are protecting

Usually it is one of three things: the identity of the molecule and its use, a route you developed, or know-how about yields and impurities. Each needs a different level of care. If the molecule is already public and the plant develops the route, your main asset may be the commercial relationship, not the chemistry.

Practical protection

  • Sign an NDA before sharing anything technical, with Indian law and a clear forum for disputes.
  • Share in stages: enough for a quote first, full detail only after you choose the plant.
  • Agree in writing who owns the route, improvements and data developed for you.
  • Restrict the plant from selling the product, or anything made by your route, to others.
  • Consider patents in India and your markets for a genuinely new process.
  • Limit who at the plant sees the full package, and ask for named contacts.
  • Keep the right to audit, and visit during scale-up.

India does not have a separate trade secrets statute. Protection relies mainly on contracts and on the courts' approach to breach of confidence. That makes a well-drafted agreement more important, not less. Take advice from an Indian lawyer before you share critical information.

Outsourcing intermediates raises similar questions, covered in more practical depth in protecting your process when outsourcing intermediates.

Choosing a plant

Look for a plant with development chemists, an analytical lab with HPLC and GC, pilot equipment, and experience with overseas customers. Ask how it separates customer projects. A plant audit should test these claims.

Managing the relationship

Protection is also about the relationship. A plant that values your business has less reason to misuse your information. Agree volumes, forecasts and payment terms that make the project worth its while. Keep regular contact with its technical team, not only sales. And check the market from time to time: if your molecule starts appearing in other sellers' lists, ask the plant about it promptly and in writing.

Next step

We find custom synthesis plants, audit them and help you structure disclosure. Book a free sourcing review.

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