The synthesis of biotechnologically produced pharmaceutical active ingredients such as insulin, vaccines or antibodies using micro-organisms or cell lines requires complex process conditions in which the source organism must be introduced into the bioreactor in an optimum condition; otherwise, production would be many times more expensive or impossible. Transferring technology to a new and possibly distant location, to another market and/or a different culture, creates a number of challenges for engineering specialists and pharmaceutical manufacturers.
Not only do the technical documentation and technology itself have to be considered, there are also regulatory guidelines — which vary from country to country — and compliance issues that must be addressed.
The biotechnologists at Glatt Ingenieurtechnik, Germany, know how to tackle these issues and help companies to serve or access markets such as the Middle East and India. Having completed various different assignments, they have successfully transferred biotechnological projects to the Arabian region and to India. The request for assistance from the pharmaceutical manufacturer and identification of the product mark the starting point and leads to two fundamental questions: does a suitable biotechnological manufacturing process already exist in the company, or must it be purchased by a technology provider or licensor? As soon as this availability can be clarified for the intended market area, the engineers are then able to evaluate and compare the relevant technologies according to specific criteria.
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