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Interview: Single–Use Reactors

Top–Trend Single–Use Bioreactors: Hype or Gamechanger for Bioprocesses?

| Author / Editor: PRASANTA KUMAR CHATTERJEE / Dominik Stephan

Cell Cultivation in Biopharmaceutical Processes: To enable cells to grow optimally in the production of active pharmaceutical ingredients, cells are cultivated in a bioreactor under controlled conditions. Important factors for cell growth include the composition of the nutrient medium, mixing efficiency, temperature, dissolved oxygen saturation and pH.
Cell Cultivation in Biopharmaceutical Processes: To enable cells to grow optimally in the production of active pharmaceutical ingredients, cells are cultivated in a bioreactor under controlled conditions. Important factors for cell growth include the composition of the nutrient medium, mixing efficiency, temperature, dissolved oxygen saturation and pH. (Picture: Sartorius)

A global player in dynamic markets around the world, Sartorius Stedim Biotech (SSB) offers total solutions for biotech laboratories, process technologies and equipment. The Indian arm of Sartorius has developed itself into a centre of excellence in design, engineering, production and technical support in Asia for the Sartorius Group. In a tête-à-tête with PROCESS India, Maik W. Jornitz, Sr. Vice President, Product Management, Bioprocess Solutions, North America, depicts the changing scenario in the bioprocess industry.

PROCESS:

What is the most prominent trend in the biotech industry these days?

MAIK W. JORNITZ:

One sees a very strong shift towards employing single-use technology, formerly known as disposable technology. Main technology trend drivers in singleuse technologies are bioreactors and unit operations like media and buffer prep, virus inactivation and tangential flow systems. A very unique, single-use technology supporting, innovation are flexible production containment systems, which can be assembled to a full production process design. These modular containment systems will be the production designs of the future.

How Single–Use Technologies Profit From Experience with Hazardous Waste

PROCESS:

What are the advantages of these products? Because when it comes to disposing, it can be a problem, especially in developing countries.

JORNITZ:

The industry is familiar with bio-hazardous waste, and single-use process equipment is disposed in the same way. The industry already has accepted practices to dispose sterilising grade filters, tubings, packaging materials etc. So, I do not think it is a big problem.

Yes, you have to make an effort to dispose the material in a coordinated and safe modus but there are significant advantages in terms of costs for less energy, less water, less use of chemicals for cleaning of equipment than is generally required, and less risk to carry over from one product to another.

In today’s world of fierce competition and tough regulatory compliance pressure, to remain competitive with hassle-free production, every biopharmaceutical manufacturer is looking at some key catalysts of process change – such as modularisation, flexibility, fast changeover and minimising contamination risks. Thus, technologies engrossing this paradigm shift are coming into the forefront. Rapid advancement in disposable technologies will soon make them indispensable. Read more in Single–Use Reactors: A Panacea for Future!

Emerging Markets See Wide Use of Single–Use Bioreactors

There are discussions that the impact of the single-use equipment on the environment is lesser, but these type of statements require a proper energy balance analysis to be sure.

PROCESS:

Do you find any difference in the market demand between India and other developed countries?

JORNITZ:

It is a relatively new industry for India, but, the country has developed lot of greenfield facilities. Most of these facilities are using modern bioprocess equipment, which are consequently based on single-use technology. Thus, there is a single-use technology trend not only in the developed countries – but also in the developing countries such as India and China.

Also, we see single-use unit operations’ trends in India and China. I mean, operations – such as media preparation, viral inactivation – these all are unit operations, which can be designed as a single-use assembly.

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