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?
EPCOT International
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