Interview

The success of our clients is our success

Sartorius-Stedim Biotech is globally acknowledged for its excellent membrane filtration solutions for biopharmaceutical industries. Maik W Jornitz, Group Vice President, Sartorius-Stedim Biotech reveals more to Sachin Jagdale

How would you rate the current biopharmaceutical industry from the purity and product quality point of view?

I believe that the purity and quality, efficacy and stability are very good and at a very high level. There will be new technologies entering in future which will help to purify and concentrate the biologic further in future, especially in a faster and more effective way.

How do you intend to exploit the ever expanding Indian biopharma-ceutical industry?

Absolutely, my colleague, Dr Uwe Gottschalk, who is responsible for our purification product portfolio, has given many talks to the Indian biopharmaceutical industry and he visits India on a frequent basis. Furthermore, we invest continuously in new resources, training and especially in a new production facility in Bangalore. Additionally, we are building an application research lab at the same location to enhance our services to the industry.

What are the benefits of your membrane filtration solutions?

First of all one has to point out that every filter product in the market has its advantages and all work sufficiently in the specific applications. Sartorius-Stedim concentrates not on the filter product itself, but on the applications and processes. There is not a best filter for every filtration application, but a best filter for a specific application. For this reason we decided years ago that we will enhance filter products to specific target application and with it support our clients to an optimal point. The success of our clients is our success; therefore, we will do our best to supply an optimal product and service to the client. Only this combination will suffice.

What are the criteria of choosing filters?

It depends from application to application. If it is a buffer application, a high flow filter needs to be used and the filter chosen will probably be a single layer filter design. If it is media or a vaccine product, we will target an optimal throughput filter to gain the best capacity and yield from the filter. In an application which contains preservatives or a highly valuable protein we will especially focus on a low unspecific adsorption of the filter membrane polymer. At the end of the day, trial work needs to be done to check all parameters, flow, throughput and unspecific adsorption. Only such trials can determine the best filtration solution.

What are the controversies related to the filtration process?

The main controversy, in my opinion is redundant filtration (whether we really need it), pre-filtration, post steam sterilisation integrity testing (reasons to test and compromise the filtrate side) and the marketing driven call for 0.1 micron filter use instead of 0.2 micron. There is no necessity for any of the three if proper process validation has been performed and the process has been found robust. It is a misconception that the use of any of the three topics will enhance the safety of the drug product. In instances it will actually lower the safety.

Who are your clients in India? How are your products/services different from your competitors?

All major pharmaceutical and biopharmaceutical companies present in India are our clients. All our competitors are formidable colleagues within the industry. All do a great job. There are differences between all filter vendors as everybody has a different focus. Sartorius-Stedim's focus is to serve our clients in the most optimal way for their entire process. We do not limit ourselves to a narrow product range or an individual process step; we aim to supply and support the entire process, plus the service requirements of our clients.

What is most challenging issue faced by service and technology providers like your company when providing services to biopharmaceutical industry?

Probably resources, since we strive to supply thorough and experienced services. We have to chose who we will supply such service to, as we do not have unlimited resources with the experience level required. Having said this, end of last year we started an initiative to review all our service and support personnel on a global basis and started forming teams to train and focus specialists for specific process steps. On top of this specialist group, we also started established specific key account support functions, which can service the entire process and perform plant surveys.

What are the recent regulatory changes?

The major change just has arrived with the EC Annex 1. The Annex luckily became very clear in regard to redundant filtration, i.e. it rather focuses on the point-of-use filtration step instead of banging multiple filters after each other into a process. However, the post-sterilisation, pre-filtration integrity test is worrisome as it will be difficult, if not impossible to perform such tests without compromising the sterile filtrate side.

What are your future plans?

I will put a focus on the described enhancement of our technical support functions. Additionally, I will increase efforts in our fermentation product portfolio, from a standard re-usable fermentor system to the cylindrical disposable fermentor line. We require to formulate an easy accessible product program for our clients. We are working on book number nine, which will be focused on filter testing and sizing. I will also see that PDA gets more involved in the Indian market and that we hopefully will revitalise the chapter in India. On a side line, I will make sure that the web sites for the bioprocess resources group are coming up and running as these will create immediate answer to filtration questions via the internet.

sachin.jagdale@expressindia.com