Interview

‘The use of microbiology consumables has gone up’

Dr Rahul Warke, Director R&D of HiMedia, talks to Nancy Singh about advances in the cell culture medium market vis-à-vis the pharma industry.

What is the size of the cell culture media market? What factors help a culture media company have an edge in pharmaceutical market?

Globally, the cell-culture media market is approximately about $30-40 billion. The pharma industry today is moving towards regulated markets and their products have to be manufactured and tested as per norms like USP, FDA, British and European pharmacopoeia. Therefore quality is a major factor in the industry. Additionally, one has to look at the consistency and documentation in terms of traceability analysis and compliance to international norms. We have quality systems in place like ISO 9001:2000 and ISO 13485:2003. Our facility is WHO GMP compliant, which is again mandatory for pharma industry, so that industry players are assured that the product is manufactured in a clean environment.

Giving quality products at a quality price also makes a difference. Our products are priced at almost one-third the price of any reputed international brand in the culture media market. With its affordable pricing and world-class quality, HiMedia has forced international brands to bring down their prices not only in India, but also globally. It was HiMedia that broke their monopoly in the market. This has really helped Indian pharma to economically carry forward their R&D and testing.

Do you see any significant changes in the pharma industry's demands in the past five years?

In the last decade there have been major advances in pharmaceutical microbiology. There is a huge change in terms of testing procedures and the sheer numbers of testing has gone up. Today with newer GMP facilities being set up globally, microbiological testing of the product, environment and equipment has become mandatory. This has increased testing and thus use of microbiology consumables such as culture media has gone up.

Quality control departments have to use validated procedures and products for their testing. After validating procedures and products, it becomes very difficult for them to shift to a different supplier of consumables. Consistency in product quality has become the fundamental requirement of the user today.

Which are the pharma products which form major sources of revenue for HiMedia?

In terms of major sources of revenue we can divide the products into three segments. In the biotech or fermentation sector, it's the bulk fermentation media. In the traditional pharmaceutical sector it would be the classical microbiological media, which is used for sterility testing and quality control. In the biopharma sector it is the cell culture media, where many vaccine and biomolecule manufacturers are using our products. There is a tremendous growth potential in the biopharma segment.

What are the factors that triggered the shift from animal based culture to animal-free culture media in the biotech industry?

The most important factor was the customers' convenience and demand. Mad cow disease has inculcated fear in the pharma, vaccine and the biotech industry, which was tackled by animal-free culture media, like HiVeg. Apart from this, manufacturers would have to go greater lengths just to maintain documents and ensure the origin of the animal products. This was expensive and there was always a fear on the purity of animal origin products. We thought of coming up with a product like HiVeg, which did not compromise on performance and had no animal origin material. Though this is not the only 'animal-free' culture media available, but in terms of sheer versatility, HiVeg is available in 14 other combinations instead of the traditional wheat or yeast based media bases.

Also, India being a major producer of agriculture products made it much easier. In India we have a wide variety of pulses and cereals and lots of proteins. This rich diversity has been exploited to make HiVeg vegetable peptones and media. It was sheer demand, which further encouraged the supply.

What are the critical issues that need to be taken care of to handle a product line like yours?

The first and foremost issue is quality of the products. The following concern is the method of storing the products at appropriate temperature unto the end of the shelf life and the transportation of the products under optimum conditions. Maintaining cold-chain is a big challenge in India, so for that, we have tied up with all the major courier companies. The majority of products are airlifted from us. If we require shipping the products globally we do that through cold-containers.

Is HiMedia planning to add any new products to its bouquet for the pharma sector?

For the pharma sector, we are launching a new line of air sampling systems. We already cater to this segment, but we are going to create more customer awareness and bring it in as a bigger array of products to choose from. A second line of products would be the ready-to-use prepared media that the pharma companies are sceptical about because of a lot of validation requirements. We are going to gain that confidence, and provide an entire line of ready prepared sterile products that would be validated and tested.