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

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Sartorius AG

PROCESS:

What are your future plans specifically for India?

JORNITZ:

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!”

PROCESS:

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

JORNITZ:

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

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