Disclaimer

All opinions are my own.

Monday, March 20, 2017

Strategies for Improving Batch or Creating Continuous Active Pharmaceutical Ingredient (API) Manufacturing Processes

This report was originally published in March 2011.  

It is being republished and is available to any person FREE of cost via my blog Profitability through Simplicity. Please request the report using CONTACT form. 

From time to time I will be adding to this report my perspective about chemistries of various active pharmaceutical ingredients and fine/specialty chemicals that are in the public domain.

Anyone can use the information to improve their processes. Information is a guide and its use is by their own choice and will not hold anyone liable for any damage, costs or expenses. 

Scope of this research

  • Enhance profitability by re-evaluating and re-engineering product development, manufacturing technologies, and commercialization methodologies.
  • Evaluate ways to simplify manufacturing technologies and implement sustainable processes.
  • Identify examples where process enhancements have had a substantial impact on yield and profitability.
  • Understand the need for review of current patenting strategies.
  • Assess the advantages of quality by design versus quality by analysis processes.

The commercialization of a new drug molecule should commence when the development of the molecule starts in the laboratory. This methodology gives the process chemist and chemical engineer familiarity with the chemicals and their properties, and allows them to share ideas and use the acquired knowledge for future projects.
An alternative business and manufacturing strategy has to be considered when catering to the drug needs of people in developing countries, who often cannot afford to pay prices of developed countries. These markets are showing 5–7% growth, compared to 2–3% in the developed countries.

Meeting regulatory needs takes precedence over having the most optimum process. In spite of companies’ efforts to meet regulations, there are often recalls due to poor practice. Recalls and citations are proof not only that the regulations are cumbersome to meet, but also that companies do not have control of their processes.

  • How can my company achieve economies of scale when manufacturing APIs?
  • What steps need to be taken to make it more difficult for generics companies to cannibalize market share once a drug's patent expires?
  • What process manufacturing lessons can be learnt from fine/specialty chemical companies?
  • Why does regulatory burden take precedence over optimizing API manufacturing processes?
  • Why should chemists and chemical engineers consider the commercialization of a product whilst it is still in laboratory development?





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