Biopharmaceutical companies looking to manufacture in the Middle East or India may find they can’t simply transfer the plant they’ve been using successfully in Europe, for logistic as well as regulatory reasons. An expert in integrated process technology and engineering, Glatt Ingenieurtechnik outlines the potential pitfalls and solutions.
Transferring production of any pharmaceutical that contains biotechnologically produced active ingredients such as insulin, vaccines or antibodies using micro-organisms to a new country — especially one on a different continent — creates a number of challenges. Not only do technical documentation and technology have to be considered, but regulatory guidelines, which vary from country to country, and compliance issues must be addressed. The technology and engineering experts at German company Glatt Ingenieurtechnik know how to tackle these issues and have helped several companies to set up manufacturing facilities successfully and smoothly across the Middle East and India.
For many pharmaceutical projects, early availability is important and fast time-to-market are imperative for the manufacturer. Effective project management and scheduling are therefore crucial. Working to a clearly defined structure based on sound experience, when it receives an initial enquiry from a pharmaceutical manufacturer, Glatt asks two fundamental questions: Does a suitable biotechnological production process already exist within the company? Or will it need to be purchased from a technology provider or licensor? As soon as these points are clarified, the Glatt engineering team will begin to evaluate and compare the relevant technologies, in line with the pharma company’s specific criteria.
It is important that a defined and stable micro-organism or a high yield cell line exists, and that the scale and status of the biotechnological process has been assessed to attain regulatory approval for the pharmaceutical production in the Middle East, in India or other process technology receiving regions. If the procedure only exists in a laboratory, scale-up may be available at a pilot plant or — better still — a proven and commercial- scale process may have already been established at a potential process technology donor location.
This status report determines the schedule of the entire project. Additional evaluation criteria include, among other things, secured patent status, any royalties to be paid, material requirements, expected turnover rate and yield. It is also important to know whether guarantees can be given regarding process parameters such as yield and product purity.
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