Custom synthesis is an increasingly common approach in the development of active pharmaceutical ingredients (APIs). Creating tailor-made synthetic processes enables the fulfillment of specific requirements that commercially available compounds cannot meet. In this article, we explore the contexts in which it is used and the factors that determine its effectiveness.
What is custom synthesis and when is it used?
Custom synthesis involves developing a tailor-made synthetic process to produce a specific chemical substance. In the pharmaceutical industry, this may involve the production of active pharmaceutical ingredients (APIs), intermediates, or molecules intended for other uses.
This service is used when a product is not available on the market, when a new synthetic route is needed, or when an existing process requires significant improvements.
How a custom synthesis project is developed
Although each project has its own specific characteristics, a custom synthesis generally follows several key steps:
- Needs analysis: defining the objectives, the compound’s characteristics, the quantities, and the requirements to meet.
- Synthesis route study: evaluating possible synthesis strategies, considering feasibility, efficiency, and the availability of raw materials.
- Optimization: defining the most suitable operating conditions to maximize performance.
- Scale-up: transfer from laboratory to pilot or industrial scale.
- Monitoring: development of the analytical systems and methods necessary to verify compliance with the required specifications.
- Preparation of regulatory documentation: preparation of technical documents (such as ASMF/DMF, CEP, CESP, and other dossiers) required for registration and marketing activities.
Key elements of an effective custom synthesis
To achieve a reliable process, it is not enough to obtain the desired molecule. The synthesis must ensure:
Scalability
The production methodology must maintain consistent performance and standards even when scaled up to larger volumes.
Impurity Control
The identification and management of impurities are fundamental to ensuring the quality, safety, and suitability of the final product.
Robustness
A thorough understanding of critical parameters enables the creation of a stable, reproducible process that delivers reliable results even in the face of normal operational variability.
Regulatory Compliance
The production and development of active pharmaceutical ingredients must comply with Good Manufacturing Practices (GMP) and major international guidelines by applying monitoring, documentation, and traceability protocols throughout the entire production cycle.
The value of a specialized partner in custom synthesis
Custom synthesis requires expertise spanning process chemistry, quality control, industrial transfer activities, and regulatory management. For this reason, many companies choose to rely on specialized partners who can provide the know-how and experience needed to identify solutions best suited to their project needs.
It is exactly Flarer’s approach: we offer a Custom Synthesis service dedicated to the manufacture of active pharmaceutical ingredients and pharmaceutical intermediates. With a network of qualified partners and personalized management, we support our clients from the documentation phase through to large-scale commercialization of the substances, ensuring technical support and compliance with industry standards and regulations.
For more information, contact our team.