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Pharmaceutical Processing - Batch or A Continuous Process: A Choice

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81 views2 pages

Pharmaceutical Processing - Batch or A Continuous Process: A Choice

Uploaded by

diyar che
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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March 2005

Pharmaceutical Processing - Batch or a Continuous Process: A


Choice
by Girish Malhotra, President, EPCOT International.

Most pharmaceuticals are organic or inorganic chemicals synthesized and then converted into
an easily administrable dosage form for human consumption. This conversion can involve
combining the active ingredient with inert materials to facilitate dispensation. Active
pharmaceutical ingredients, or “API’s”, have to be manufactured using methods outlined in
the FDA’s “Guideline on General Principles Of Process Validation” for safety reasons.

A review of these guidelines indicates a basic assumption that most API’s are produced by
batch processes. This is probably true. The slant of these guidelines is toward batch processes
rather than continuous processes. There is no mention of continuous processes in the FDA
guidelines.

If the reaction chemistry and kinetics of each intermediate reaction component of an API is
right (i.e. zero order or close), it is very possible to produce the API by a continuous process.
One has to review the chemistry of each step and their translation to actual unit operations.
Chemical engineers and chemists can easily access and demonstrate this as part of the
commercialization process.

Continuous processes have the following advantages over a batch process:

• Production of a narrow specification product, i.e. higher and consistent product quality.

• Reduced manufacturing cost.

• Improved asset utilization.

• Reduced waste.

The above advantages improve profitability. During Interphex 2004 a desire to move to
continuous processes and production was expressed but the general belief is that “If it is not
broken don’t fix it”. In order to overcome resistance in the industry, scientists and engineers
have to use proven principles to demonstrate how continuous processes can be
commercialized rather than present reasons why such processes cannot be developed. Process
innovation can overcome any NIH (not invented here) barrier easily.

The value and benefits of continuous processing have been discussed many times in
numerous publications. In light of the benefits stated above, why is the industry still hesitant
to embrace continuous processes for pharmaceutical production? I can conjecture but it may
not be correct. I believe that since most chemical compounds are synthesized in the
laboratory using batch processes; and their efficacy and applicability is proven under
rigorous scrutiny in a batch setting; not much effort is expended to develop a continuous
process. In addition, every test sample is produced by a batch process.

Once the pharmaceutical value of the API is realized, the pressure to commercialize the API
is extremely high, therefore not much effort or time is expended to consider if the product
can be manufactured by a continuous process. Even if the API could be produced using a
continuous process, the FDA approval process, which is biased toward batch processing, may
interfere and impede the development and commercialization of a continuous process. The
time-intensive approval process can become a stumbling block and prevent consideration and
development of improved processes. Pharmaceutical companies hesitate to spend money due
to drug safety compliance requirements. An API may have a better chance of being produced
by a continuous process once it is coming “off-patent”.

It is my belief that among the developers of API and regulators (FDA) there are a significant
number of chemists, pharmacists and engineers who believe in continuous processing. The
viability of continuous processing has to be demonstrated and it would be a win-win
situation. All that is missing is for someone to step up to the plate. Recently we have been
seeing higher selling prices of high volume drugs. Basic laws of economics, we all have been
taught, suggest that this shouldn’t happen. There are two possible explanations that may be
given for the increase in selling price.

1. Increased margin.

2. Increased manufacturing costs.

The benefit of higher margins will be immediately seen in the increased profits of the
pharmaceutical company. If increased profits are not seen, then the price increase can only be
attributed to higher manufacturing costs which are against the laws of economics, especially
when sales are increasing. We all know that the more you produce, the more efficient one
becomes and the cost is reduced. If one justifies increased costs due to meeting FDA
regulations then the only remedy is to have a better batch, semi-batch, or continuous process.

The challenge is on entrepreneurs, chemists and engineers to see which API can be produced
by a better process, make it happen and lower the healthcare cost for our fellow human
beings while maintaining the profitability that is necessary for the development of better and
new pharmaceuticals.

About the author: Before founding EPCOT International, Girish Malhotra, PE worked in
various capacities in chemical manufacturing, technology development and operations fields.
Today he is a consultant for fine and specialty chemicals, and coatings companies.

About the company: EPCOT International enhances profitability by improving


manufacturing efficiency and quality, improving asset utilization and process technology,
implementing pollution prevention programs, process and technology development, process
optimization, reducing time to market and competitive analysis.
© 2004 Reed Business Information,a division of Reed Business
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Phone: 973-292-5100, Fax: 973-539-3476
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