The Changing Face of the Biopharmaceutical Industry and Single-Use Processing Systems

Disposables (Single-Use) systems are in use or in the top consideration in over 90% of pharmaceutical and biotechnology companies’ biomanufacturing processes. Dr Mahbubur Rahman, Deputy Director - Analytical Process & Technology, Industrial Operations at Sanofi Pasteur, gives tips on developing methodologies to choose the right disposable equipment for your biomanufacturing process.

Pharma IQ:
I’d like to begin by asking you to give us an overall picture of the disposables in biomanufacturing industry in Asia.
Dr. Mahbubur Rahman: The disposable biotechnology industry is changing the landscape in the biopharmaceutical industry because there is a lot of cost involved using capital equipment, like cleaning validation, but disposable solutions have saved a lot of money and effort for the biopharmaceutical industry. For example, biojectors, DFF systems, pre-filter syringes, disposable column chromatography and other techniques can be easily used without cleaning validations and additional testing; so the landscape is evolving for the biopharmaceutical industry.
Pharma IQ: Is the biomanufacturing industry in Asia much different to that in the US?
Dr. Mahbubur Rahman: I have limited experience with the Asian industry because I never worked there, but in the West, it is changing, as most of the biopharmaceutical industry is changing. The main change is around the multi-use system; and the transition from stainless steel to single-use systems, which are easier to control and save money and effort.
Pharma IQ: I wanted to ask you about single-use processing systems. Can you maybe explain the benefits of this move as opposed to staying with the traditional capital intensive systems?

Dr. Mahbubur Rahman: By using a single-use system you don’t need to do any validation activities or further process testing, which is more expensive, so single-use systems save time and money.
Pharma IQ: What must an organisation consider when selecting the right disposable equipment, whether that’s single-use processing or other, for their manufacturing process?
Dr. Mahbubur Rahman: The thing to consider is the extractable leachable as well as the development and cooperation challenges. An organisation also needs to ensure the integration of  the disposable biojector into the existing system and whether it fits well or not.
Pharma IQ: Dr Mahbubur, what are the most exciting things currently happening in the disposables industry today?
Dr Mahbubur Rahman: The most exciting things right now are the biojector that can grow and DFF systems. Instead of stainless steel, you can use single-use systems in the DFF filter, as well as column chromatography, and column chromatographic metrics, which you don’t need to carry out validation activities for that. The disposable technique improves the quality of the product, is easier to bring to the market and the product timeline is shorter than what it is for stainless steel use.
Pharma IQ: For the rest of 2012, do you predict the disposable industry to grow in quantity and importance within organisations or do you expect there to be a decline?
Dr Mahbubur Rahman: It will grow tremendously because it saves a lot of capital investment.
Pharma IQ: Thank you very much.
Interview conducted by Niamh Madigan.
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