India is a key market for us, it is a pharma centre of excellence

Alessandra Vizza, Regional Business Director, Corning Reactor Technologies talks about Advanced-Flow Reactors (AFR) and explains how it can help Indian pharma companies upscale their production output by providing continuous process production capacity of up to hundreds of kilograms per hour, the company’s plans for the Indian market and more, in interaction with Lakshmipriya Nair

Tell us about Corning’s Advanced-Flow Reactors. What are the efficiencies and benefits that this technology can usher into pharma manufacturing?  

Advanced-Flow Reactors enable greater efficiency in production as compared to traditional batch reactors due to their smaller footprint in manufacturing facilities and ability to scale from the laboratory to full production in less than half the time it takes in batch production systems. Starting materials are dosed into Advanced-Flow Reactors to flow through heart-shaped mixing structures which are specially designed to promote thorough mixing while keeping intense heat exchange to ensure isothermal conditions. These features allow the production of a large portfolio of desired chemical reactions such as nitration, chlorination, oxidation, hydrogenation, and many others. The ability to control the feed ingredient ratios into the reactors could enable companies to safely produce a specifically desired quantity of a product at consistent quality and at a lower cost. Backed by Corning’s engineering and production experience, continuous flow can provide an economically and environmentally sound alternative to batch production. With the potential for more efficient material use, lower waste production, and higher safety margins, Corning’s Advanced-Flow Reactor technology offers fine and speciality chemical, as well as pharma manufacturers a cost-effective solution to meet the current demand for their products.  

Why will this technology suit the cost-sensitive Indian market, given the current scenario where it is trying to be more self-reliant?   

Consistently producing a unique balance of properties for fine and specialty chemicals is an ongoing challenge for all manufacturers. Traditional batch processing techniques have been proven over decades of use, but may have efficiency, quality, and safety shortcomings that could be particularly troublesome in specialty chemical production. Chemical engineers have long recognised that continuous flow processing is an efficient and cost-effective alternative to batch processing. Until recently, continuous processing mainly worked in laboratories that needed to produce small volumes of chemicals for testing and product development and not for mass production.  

Flow chemistry is an emerging technology in the industry and has been gaining the attention of many players in the market due to the advantages offered by the technology over traditional batch production, such as bulk production and cost-effectiveness. Companies are keen to adopt strategies in order to tap a higher market share. India is a prominent and rapidly growing presence in the global market. It is the largest provider of generic medicines globally, occupying a 20 per cent share in global supply by volume. India ranks third worldwide for production by volume and 14th by value. India is the only country with the largest number of US-FDA compliant Pharma plants (more than 262 including APIs) outside of the US. India has more than 2000 WHO-GMP approved pharma plants and 253 European Directorate of Quality Medicines (EDQM) approved plants.

The manufacture of drugs in India, many life-saving, is dependent on sourcing raw material or active pharma ingredients (APIs) from China. India imports 70 per cent of its APIs and intermediaries from China. The government, in August 2020, had approved the production linked incentive (PLI) Scheme for the promotion of domestic manufacturing of critical key starting materials (KSMs), drug intermediates, active pharma ingredients (APIs) in India. Through this scheme, the government wants to attain self-reliance and reduce import dependence. This proposed scheme will give a thrust to the pharma industry in the country, especially in complex formulations, and will help the sector regain dominance.  

As a result of this scheme, pharma, fine and specialty chemicals manufacturers have the opportunity to invest in developing and expanding their focus on new technology, like flow reactor technology that is less risky, more efficient and less costly alternative to traditional batch processes. This technology provides a sustainable solution to current processes practised in these industries.   

Can AFR be customised to meet specific needs and integrated into existing processing infrastructures in Indian pharma facilities?  

Advanced-Flow Reactors can be customised to meet specific needs. They can also be integrated into existing chemical processing infrastructures with little or no downtime. The reactors have small footprints so companies don’t have to expand or build new facilities to produce new product lines. Scaling up production with these reactors can be as easy as increasing the volume of ingredients fed into them. Advanced-Flow Reactors offer seamless scale-up that can reduce, by as much as 50 per cent, the time required to bring a new product from the laboratory to production and keep consistent quality at all the development stages. 

Batch processing, by comparison, consists of passing fixed quantities of ingredients along a production vessel according to a fixed formula to yield a specific amount of finished product. Modifying formulas or repeating a production can cause quality to defer from batch to batch. Additionally, batch production requires a lot of space. Once a chemistry passes a section of the production line, that section is idle until the next batch comes through. At the same time, batch production could pose higher safety risks than continuous flow production because of the large amounts of reactive chemicals combined in a typical batch production process. Advanced-Flow Reactors, at any instance use, smaller amounts of chemicals so can reduce the risk of possible accidents.  

How many installations in India, specifically in the life sciences and pharma sectors? 

For confidentiality reasons, I can’t share the names of the customers. But, I can mention that in India, there are a lot of installations. We work with mainly all the big pharma companies present in the Indian market. India is a market that is very key for us because it is a pharma Centre of Excellence. 

You mentioned that India is a very important market for Corning. So, can you tell me about your immediate plans for this market? 

As a global company, we have a strategy that is made globally. India is one of the countries where a lot is happening, pharmaceutically. So, we have a team over here to cater to this market. We try to spend a lot of time with our customers to be able to respond to all their technical questions as well as having an application engineer on-site and benefits from the remote team. 

In India, we have a partnership with IIT Delhi where we are proactively establishing a centre to not only help the industry participants to touch and feel the reactor and do some chemistries but also to educate the future generation of chemical engineers to be aware of this technology so that they can consider this as a tool for their applications.

It is an R&D initiative and as well as a commercial initiative. We want our customers to come and run their demos at IIT Delhi so that they can not only hear about the technology but touch and feel it. They can play with the technology at IIT Delhi. 

In the short to medium term, our strategy is helping all the customers using the technology to create a more successful story. In parallel, we try to educate more people about the product, just to be sure that the new users and the people in the industry have enough awareness of our technology.