Filtration Observations

September 21, 2005

Industry experts often have their pulse on emerging trends in the biotechnology arena. BioPharm International was fortunate to catch up with Pall Corporation’s Ken Frank recently, and heard his thoughts on the ever-evolving world of filtration. Read Ken’s observations about the current state of this field, where R&D resources are focused, and what may lie ahead for filtration as an industry which harbors great potential for growth in the future.

Filtration Observations

Recently BioPharm International’s Pamela Holland-Moritz, senior editor, had a few moments to catch up with Ken Frank, president of biopharmaceuticals division and corporate vice president, Pall Corporation to discuss his current assessment of future areas of growth for filtration in the biopharm arena:

BioPharm: In your opinion, what is the current state of filtration in the marketplace? How does it compare to five or ten years ago?

Ken Frank: If you look at the current biotech/pharmaceutical industry, we need to look beyond filtration because within important parts of biotechnology processing, there are a lot of other complementary technologies that are also used. A big difference is that in the pharmaceutical industry ten years ago, most of the filtration requirements were in formulation and filling within classical pharmaceutical manufacturing. There were applications on cell culture and in biotech, but this was at a relatively modest scale in most instances.
Most of the action today is in large-scale biotech where a lot of the focus and product development is associated with separation and purification technologies for use in large-scale, monoclonal-antibody production based on mammalian cell culture. Such processes are very filter intensive as everything going into the bioreactor must be sterile and everything coming into contact with the product throughout the multiple step downstream process must be sterile to protect against microbiological contamination.

BioPharm: In your opinion, what drives the current market?

Ken Frank: I think the biggest driver today is the increased scale of biotech manufacturing. The new biotech drugs treat chronic diseases and the volumes of protein produced is extremely large. Bioreactors have increased in size substantially over the last few years, with new factories installing 20,000-liter plus culture vessels. This is 10 times the size of the largest systems not so many years ago. The shear volumes and value of the materials to be processed put new demands on the filtration and purification technologies.

BioPharm: What do you think research is concentrating on? What kind of technique will likely be the best in getting the most bang for your buck, so to speak?

Ken Frank: I think there are trends towards asymmetric membrane these days because of the potential for higher flow rates and throughputs. This also addresses the needs for processing larger batch volumes in biotech.

BioPharm: In your opinion, is there a filtration technique that will surge in usage over the next decade, and if so, why?

Ken Frank: It’s always difficult to predict the future. I think the current trend is very clear that there will still be big demands on the tangential flow filtration for concentration / diafiltration but there is still a very, very large demand for conventional direct-flow filtration for things like viral clearance steps, where the demands of bio-safety are increasing the need for cost-effective and easy-to-use virus removal technologies.

BioPharm: What is your feeling about the current trend towards the use of disposables?

Ken Frank: I think it’s a trend that will increase, particularly in the production of clinical trial materials and in some of the multi-purpose plants. Cleaning, cleaning validation, and the resultant down time can be a significant cost in some plants, and if we can eliminate those by using cost-effective, single-use products, we can reduce overall manufacturing costs. For the very large single-product plant the economic balance may be different and I believe that we will see disposables and stainless based processing both being successful in different stages or scales of drug development and production.

BioPharm: If you had to point to one most significant development of filtration in recent years, what would that be?

Ken Frank: From my narrow prospective, which has been in pharmaceutical processing, I think the ability to package more useable filtration media into a small envelope using Ultipleatâ technology has been a significant step forward in filtration economics. Smaller filters able to process more materials also help promote the trend towards disposables.

BioPharm: Overall, how would you describe the future of filtration? Is it going to be an ever-evolving area or has it maxed out to as far as it can go?

Ken Frank: I think some of the easy technology gains have already happened and some of the more difficult challenges lie ahead. However, if I had to pick one area for possible future focus it would be activated membranes. These are already used as membrane chromatography devices for host cell protein and DNA clearance, and I believe that there is more potential to use membranes as a carrier for affinity-based separation.


BioPharm
: As for the unexpected turn of events with Vioxx, do you think that is going to have an effect on the field of filtration in any way?

Ken Frank: Not specifically. However, I think all of the pressures on the industry for safety and compliance with increasing regulations put pressure on suppliers, including filtration suppliers, to make sure we can meet our customer requirements. The increased attention by customers on filtration and also the fact that filtration in the plant is a significant expenditure these days translates into the need for developing products that our customers can rely on.