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

Author / Editor: PRASANTA KUMAR CHATTERJEE / Dominik Stephan

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.

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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)


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


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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


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


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.


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


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.


What are the Sartorius’ major expansion plans for 2012?


In 2012, we plan to inaugurate three new production facilities. The facility at Yauco, Puerto Rico will double the capacity of single-use bags and filters. The other facility in Goettingen, Germany is dedicated for membrane production and, furthermore, a new facility is being built in Guxhagen, Germany for the production and assembly of stainless steel bioreactors and bioreactor equipment. All three facilities will be inaugurated this year to extend our capacities and therefore service to our clients.

“Major Growth in North America and Asia”

In addition, we have two major growth initiatives – one in North America and the other in Asia – specifically in India and China. These initiatives are – to build up technical support and services resources as well as the supporting infrastructures to serve our clients better.


What are the strengths of Biohit, which will help Sartorius in offering more bundled packages to its customers?


Apart from Bioprocess Solutions, Sartorius also has Lab Products and Services division. Through this division, Sartorius offers its own lab equipment portfolio. Biohit is a very strong pipettes supplier and innovator, which complements Sartorius’ portfolio. Thanks to this acquisition, we will be able to offer more products and services for our lab customers.

“Expansion? The Situation is Mixed...”


Will Sartorius keep on expanding its business with such acquisitions in future, or will it develop technologies or products on its own too?


The situation is mixed when it comes to expansion. First and foremost, we believe in organic growth – so we want to grow the company by selling our own product portfolio. The moment we see the gap in our portfolio and we know we would not be able to fill that for some reason, we think of other options. In such cases, there are two possibilities either we partner with the company and form alliance, or we acquire the company.

Another way is we partner with a company with the options to acquire later on. Making these type of choices always depends on the criticality of the product portfolio we gained through a partner. If we see that our customers see it essential for Sartorius Stedim to have and maintain the product portfolio, we certainly look into the supply assurance and therefore look at ways to bring such products into the Sartorius Stedim group. Very classical examples were the acquisition of BBI fermentation products and Stedim’s single-use technologies.

Potentials for Further Development in Single–Use Bioreactor Technologies


What are the R&D areas that you are concentrating on?


See, R&D is driven by customers and not by Sartorius internally. Taking the example of single-use technology again, there is a high demand from our clients to bring single-use technology not only into the up-stream side, for example fermentation but also into the downstream process steps for example in purification technologies. Here again we work on new innovative membrane chromatography systems to reduce processing time and resources.

We also believe that the industry is looking for standardisation of contact layers, the polymeric film that comes in contact with the products, but flexibility of the film laminates. More work needs to be done in this

area, but we see progress to fulfill future requirements.

New Trends for Single–Use Technology

Then from critical processing step, the sterilising grade filtration area, we will launch very shortly next generation sterlising grade filters, which is called Sartopore Platinum, a unique high performance filter.

Another area that we are currently working on is the prefilters to protect sterilising grade filters and viral filters. We need to have new pre-filtration strategies, so, we are looking into nano-fibre technologies – and we will launch nano-fibre pre-filters, which have a much more tightened contaminant separation and total throughput capacity.

The G–Con: Sartorius' New Development

We again have another innovative system, which we are bringing out with our alliance with G-Con. This is the company that produces flexible production modules which include independent air handling systems and utility connectivity. They can be utilised as flexible production areas with their own clean room capacities. We believe this will be the really innovative and groundbreaking technology – when it comes to new production designs and new production facilities.


What are your future plans specifically for India?


The Indian industry is evolving. It is not just about solid dose and APIs, but it is moving more and more towards using sterile formulations, so, we see a large opportunity into validation support.

When it comes to sterilising grade filter validation or process validation, the industry needs support. For that reason, we have built up a validation support lab at Bengaluru, and we have also employed more resources in validation service side.

On the other hand, there is the application side – which we call application service or application specialists’ side. Our technical staff goes and support user companies in their process designing and optimisation.

“Very Strong Resources for Integrated Solutions in India”

And the third block, which I would say, we have built up in India very strong resources to offer integrated solutions. This integrated solutions group is an engineering partner to the industry.

We get many requests from our customers – not for just products or unit operations – but for designing an entire process and creating platforms for certain processes. The key is not just putting equipment in but to ensure that client and support talk to each other and offer an optimum facility design in terms of flow, suitability, layout and automation besides being smart about making it cost effective. We've been executing several such integrated solution-based projects, even in India.

“No Longer Only APIs – India is Evolving!”


What is your message to the Indian bio-pharma sector?


I have travelled India many times, and every year I come to India – it is a different India. What I see now is that the industry is not any longer focusing on just APIs – but it is evolving. We had a discussion that Indian biopharmaceutical industry is now eyeing the European and US markets – not just with APIs but probably also at one point with sterile drugs. The compliance pressures are increasing.

There is very high energy level within the industry; there is a large build up within the industry. I believe that India is evolving very fast and requires lot of support and knowledge. That is the reason why we say it is the right time for PDA (Parental Drug Association) to fill up that knowledge gap, and support the industry to actually link the industry to regulators and also to bring training towards the industry and its regulators.

More about Sartorius' Univessel SU, a single use bioreactor for small volumes in Single use for small-scale cell culture applications .

* Courteousy of PROCESS India