Challenges and solutions in the synthesis of APIs
Individualized medicine, more specific drugs, very specific targets… All these trends are increasing the complexity of pharmaceutical molecules, which in turn poses several challenges in their development and manufacturing, which can only be addressed with multiple technological capabilities, right from the initial stages of the process, to support the later stages of drug development.
One of the main challenges we may encounter in this process is the characterization and control of the solid form of APIs, as this may affect their solubility, bioavailability and efficacy. This problem has increased in recent years due to the increasing insolubility of drugs and the necessary control of polymorphism or particle size distribution.
Another important and frequent challenge is the search for new synthetic production routes for APIs that are more efficient, environmentally sustainable and cost-effective. At the same time, working in an agile and flexible way to deliver the product to the customer in the shortest possible time.
And of course, APIs must meet strict quality and purity regulations, which requires a GMP-compliant facility that is subject to rigorous controls to ensure the safety and efficacy of the drugs.
How to address these trends
To address the complexity of APIs, the pharmaceutical industry establishes strong partnerships with CDMOs that offer a comprehensive service for all phases of API development.
The way the pharmaceutical industry addresses these trends is by establishing strong partnerships with Third Party Development and Manufacturing Organizations (CDMOs) that offer a one-stop shop for all phases of API development. At AGC Pharma Chemicals, for example, we are an expert CDMO for intermediates and APIs, and we work closely with our customers, providing them with comprehensive, customized support at every stage of the process, throughout the entire product lifecycle.
As a CDMO, we must be able to provide our customers with the agility, flexibility and tailored solutions they need. How? With expert personnel and versatile, agile and reliable facilities. For example, thanks to our strategically designed facilities, our R&D team works closely with Production and Quality, transferring knowledge and information quickly and efficiently. We have state-of-the-art technologies and rigorous quality control systems to ensure the purity, quality and stability of the APIs we produce.
In conclusion, a CDMO with expertise in APIs must understand and address current trends in API development and manufacturing with a strategic approach, work closely with the customer from the earliest stages of the process, provide customized support at every stage, and adapt quickly to their specific needs. At AGC Pharma Chemicals we are clear about the goal of our capabilities: to provide the best quality CDMO products and solutions to improve people’s lives.