Biopharmaceutical Manufacturing

The challenges

Rustom Mody,  Director, Quality and Strategic Research, Intas Biopharmaceuticals Limited, India

Asia is emerging strongly in the area of biopharmaceutical manufacturing. More and more companies are confident of offering quality products and / or services. In the span of past two years, the perception of having an Asian manufacturing partner has been very positive, with nearly 80 per cent of small and large companies eyeing to outsource manufacturing to Asian biopharmaceutical companies.

How is India placed in this market?

India has kept excellent pace when it comes to adoption of international regulatory standards, especially with respect to facility and equipments. Indian companies have the muscle to build quality plants and machinery, and this is evident from the highest number of US FDA-approved plants in India, outside of USA.

An interesting observation is in the area of biogeneric space. Many companies are launching the same product, e.g. there are over 12 brands of Erythropoietin (EPO) in the Indian market. This has not dampened the spirit of Indian biopharmaceutical companies and has certainly benefited the customer.

What are the current challenges that companies face in biopharmaceutical manufacturing?

The operational sizes of many of the fill-finish plants are quite large. What is lacking is the large-scale bulk manufacturing capacities for mammalian cell-culture derived products. This is an area where Indian companies are lagging currently, and it would take at least a couple of years before such plants get into operation.

Biopharmaceutical companies in India, in spite of the abundant qualified professionals, still have a manpower resource crunch, especially at higher levels. One reason, which could be sited, is that biopharmaceutical manufacturing began late in the 1990s and the industry has not aged as much to have ample number of high-level professionals who are specialised in this sector.

Although the regulatory agencies are facilitating the introduction of various biopharmaceuticals products by way of streamlining regulatory pathway, there is a gap between the quality of the biopharmaceuticals manufactured in regulated countries and that manufactured in India. Take the example of biogenerics. The regulatory requirements are far less stringent for clearance of biogeneric products in India than they are in the regulated markets. The wisdom behind keeping the regulatory barriers somewhat lower, has favoured introduction of many lifesaving biotherapeutics in the Indian market, which otherwise would have been impossible. However, on the long run, this could create a negative perception of Indian biopharmaceutical products, if the bar is not raised now.

The global manufacturing capacity in the last ten years has increased multi-fold while the demand has decreased considerably. How is this excess capacity being utilised?

Demand and supply follow a cyclical pattern. Just a few years back there was a severe shortage of mammalian cell culture bioreactor capacities and now it is not the situation.

Biopharmaceutical manufacturing is fast moving to countries like India and China where there is considerable cost-saving. In order to be cost-competitive, even the big biopharmaceutical companies are considering tie-ups with companies in India and China to offshore manufacturing of their authorised biogenerics.

Given the high cost of production and decreasing demand, is it economically feasible to implement PAT in biopharmaceutical manufacturing?

PAT is a valuable tool that is not as costly as it seems. By applying PAT, one can improve consistency of a process, thereby eliminate costly failures, and need for investigations.

For biopharmaceuticals, the cost of bulk or finished product far exceeds chemical APIs and this should justify higher investments in PAT.

What according to you are the key drivers for the future growth in this industry?

The key drivers for the future of biopharmaceutical companies will be to come out of the Biogeneric mindset and look at novelty. The “me too” mindset must be replaced by some tactical and strategic manoeuvre. The opportunities in India are far too many and companies can leverage many options for furthering their businesses.

Any other issues you would like to comment on.

The number of Biotechnology and Biopharmaceutical patents filed in Indian Patent Office is growing by the day. If patents granted in India are to be taken seriously, there is a need for a serious prior art study by these patent offices. Presently this is not done to the standards required, which can lead to serious legal tangles in the coming years.

Author Bio

Rustom Mody

Rustom Mody has 11 years of experience in the pharmaceutical industry. He currently heads the Quality Management System and Strategic Research Initiative at Intas Biopharmaceuticals Limited. He has worked in various aspects of project development such as plant design and setup, process and method development, scale-up and has interfaced with various National / International regulatory agencies.

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