Biopharmaceutical Production How to Move Smoothly and Quickly into Asian Markets

Author / Editor: Dirk Steinhäuser* / M.A. Manja Wühr

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.

Related Vendors

Training staff early on helped Julphar Gulf Pharmaceuticals to achieve speedy commissioning and operation start at its new biotech plant in the UAE.
Training staff early on helped Julphar Gulf Pharmaceuticals to achieve speedy commissioning and operation start at its new biotech plant in the UAE.
(Source: Julphar)

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.

Major Plant Engineering GROAB is a project database for international major plant engineering and construction. You can find more than 5500 projects within 13 categories. Learn more about GROAB and test the database.

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.

Subscribe to the newsletter now

Don't Miss out on Our Best Content

By clicking on „Subscribe to Newsletter“ I agree to the processing and use of my data according to the consent form (please expand for details) and accept the Terms of Use. For more information, please see our Privacy Policy.

Unfold for details of your consent