A cornerstone of the pharmaceutical business is a consistent supply of high-quality active pharmaceutical ingredients (APIs). Maintaining the consistency in the quality of APIs in each batch influence the overall quality and safety of the final drug produced. Therefore, adhering to the Critical Quality Attributes (CQAs) is vital to effective patient therapy and patient safety.
In a previous article, we shared how a mighty 80% of the world's active pharmaceutical ingredients (APIs) are dependent on crystallisation. The crystallisation process is complex and requires continuous monitoring to reach optimal quality with minimal waste.
The reality of process monitoring
The performance of the crystal manufacturing process is mostly determined by off-line analysis of the physical and chemical quality attributes of the API after the crystallisation process is complete. This old-hat way has little control over the manufacturing processes, leading to - inconsistent product quality, variable yields, and a significant proportion of batch waste. Here is a piece of information we recently discovered:
You might know that the pharmaceutical industry loses $50 billion annually to unsustainable manufacturing. Variably, the worldwide production of API is between 65 million to 100 million kg per year. However, according to this source, the API industry generates a whopping 10 billion kilograms of waste, and they spend around $20 billion to dispose of this waste! Yes, we too needed a few moments to digest this fact!
The gaps in API manufacturing
In the highly regulated pharma industry, data is essential. A massive quantity of process and analytical data are generated during manufacturing processes, and the integrity of this data is cardinal. The API industry is facing challenges
to meet many of these requirements. Some related to crystallisation are:
poor control and efficiency of the crystallisation process
infrastructure and knowledge gaps in generation and management of process data
meeting a timely supply of products with quality consistency as per regulations.
The ability of API manufacturers to deliver a consistent supply of API of the appropriate quality, and meet all regulatory requirements, directly influence the pharmaceutical industry's ability to meet the world's patient population needs.
Crystallisation and our research
To help fill this demand, the Innopharma R&D team is developing a vertically integrated Manufacturing Intelligence cloud-based platform for crystallisation unit operations, named SmartCrys. This technology suite aims to enable rapid process development and subsequently self-adjust the crystallisation processes in real-time. Platforms similar to SmartCrys will help the API industry to assure product quality with minimal loss in the future.
We at Innopharma Technology are continuously working on trailblazing research. We will be sharing the further development of our SmartCrys research project. For more thought-provoking updates, follow Innopharma Technology on LinkedIn and