Indian companies can ‘leapfrog’ to be on the cutting edge
John M Hyde, CEO, Chairman and Founder, and Karan Manocha, Senior Pharmaceutical Engineer, J M Hyde Consulting discuss with Viveka Roychowdhury why the Indian biotechology industry is at an exciting juncture today
As a consulting firm providing value-added expertise based engineering, compliance and validation services to biopharmaceutical and pharmaceutical companies, what is your reading of the Indian biotech industry?
Hyde: I think the industry is very young at this point of time. I think the real opportunity that India has is that Indian biopharma manufacturers are not shackled with a lot of baggage that western companies are shackled with, in terms of traditional approaches to manufacturing, validation and compliance. So Indian companies can really kind of ‘leapfrog’ out of that tradition and position themselves to be on the cutting edge as time goes on.
What kind of trends do you see in the market for the kind of work your company does?
Hyde: I think we are seeing much much more acceptance, by US FDA and also by EMEA, of single use technologies. Bag and silicon tubing are mostly replacing stainless steel pipes and tubes. Now the thing is that there are a number of forces driving this technology, one of which is that biopharma processes are becoming more efficient. So if in the earlier days, titres of half a gram per litre were very common, now we are seeing titres of three or four grams per litre. Some companies are even reporting titres of five or six grams per litre. That means a decrease in the size of the equipment train. At least in the sub-culture and harvest area.
The other thing that we are seeing is multi-phase chromatography column systems. The current load on the chromatography system is that it runs a day a week maybe, or half a day a week and then it sits idle for the rest of the time until the next lot comes through. These multi-phase chromatography columns are smaller, they have a lot more uptime, they require less space, less capital investment, and can have a higher utilisation. So these are some of the technologies that we are seeing coming forth here.
The other thing that I would say is that outside of centrifugation and homogenisation, nearly all of these technologies can be replaced by single use components. Capital cost goes down dramatically. Not only do you reduce equipment cost, you also get a reduced ‘footprint’ in terms of less cleaning water usage as most single use components do not require cleaning.
Manocha: And I think the market for single use products goes beyond companies having Phase I and II products. There are a lot of companies who need to changeover from one drug to another rather quickly. Single use products allow quicker changeovers versus the more traditional equipment which takes more time to changeover.
Hyde: And another part to that is that you can manufacture Phase I and II products with a reduced amount of capital. As opposed to a facility where you have a lot of capital investment and fixed equipment, some part of which you may not use again for that product. The disposable process can be designed in such a way that it is a completely closed system. That way, the effects of changeover are minimal. For processes that are open or semi-open, the environment has to be cleaned, all of the equipment has to be clean, verified as to having completely removal or removed to acceptable levels before making the next product. With disposables, that requirement goes away. Also, Installation Qualification/Operational Qualification (IQ/OQ) on the equipment, which are big investments in terms of time and efforts, go away. This is because with the bag and tubing systems, you do not need an IQ/OQ so in the end, that really reduces the time and effort not only on the product, but also on the subsequent products.
Can you give us some idea of your plans for the Indian market, what kind of client profile are you dealing with?
Hyde: Essentially we want to seek out existing biopharma companies with the aim of increasing their efficiencies and capabilities. We also want to seek out very new biopharma manufacturers that either want to build a facility or want to expand their very small facility and help them review new paradigms for engineering design and operations for compliance, to develop facilities that are very efficient, very flexible and low on cost.
What would be the price differential between a traditional manufacturing facility and these kind of systems?
As per some of the figures we have, capital costs could be a reduced by a factor of 10 of even 15 where they are all disposable. In a hybrid design which has some specific stainless steel tanks and pipes and disposables for certain key components, I would say a savings in the capital costs of a factor of 10 is not out of the question.
Manocha: The second component of cost savings comes from the operational aspect. Although there is an operational cost incurred, a lot of such plants have a zero-discharge requirement and considering that 70-80 percent of the water discharged is used for cleaning, which is reduced by the use of disposables, that would add to the savings and maintenance cost.
Hyde: Also, traditional plants have some sort of re-qualification schedule for their equipment, which would be reduced by the use of disposable. Also, there has been some work done on re-using these bags. I think a substantial portion of the bags can be re-used reducing the load on the waste disposable system. I know of some work that has been done on a re-cycling programme for buffer solutions and media solutions, so these bags can be used multiple times for these solutions. All of this will make the technology greener, and also more economical to the user.
Your reading of where the future opportunities will be?
Hyde: CROs and CMOs for biopharma products are not just reaching out to the West for molecules to make. I think in the very near future CROs within India are going to need to be manufacturing the molecules they are researching themselves. So biopharma CMOs in India are going to find quite a market here in India itself with domestic Indian CROs to make their products and I think that’s a super thing that will continue to drive the market.