Interview: Navin Lakhanpaul – VP Asia Pacific for Pharma Application, GEA Group

GEA, a global leader in pharma manufacturing solutions, has recently implemented a successful reorganization to increase their country-level presence both globally and across the Asia-Pacific region with the objective to ensure an increased “customer-centric focus”.

GEA is an innovative leader in automated manufacturing and processing technologies for the pharma industry – particularly in continuous manufacturing (CM). Could you please introduce the company and the advantages that CM solutions can offer pharma manufacturers?

“On the biopharma and liquid pharma front, we’ve seen huge investments in both South Korea and Singapore, where leading multinationals have financed large-scale bioprocessing facilities.”

GEA is a leading provider of process engineering and manufacturing solutions; one of the key application areas we serve is pharma, alongside dairy, food, beverages, chemicals, marine, environmental and utilities. Globally, GEA has a turnover of nearly EUR 4.6 billion.

Within the field of pharma, we offer end-to-end secondary manufacturing solutions for both oral solid and liquid dosage forms, including technologies for lyophilization and bioprocessing, for which we can provide everything from fermenters and bioreactors to blood fractionation systems, centrifugal separators and more. To be clear, however, our focus is very much on applications, so if a client comes to us and wants to manufacture an oncology product, or insulin, or hormones, we can supply an end-to-end manufacturing solution that meets their specific needs.

For oral solid dosage (OSD) forms, we have a continuous manufacturing (CM) platform called ConsiGmaTM. Compared with traditional batch tableting technology, continuous tableting has many advantages. The simplest is that you don’t end up with large volumes of product tied up in a given batch or have to wait until the entire batch is completed to assess the quality. There is continuous quality monitoring, and the possibility of real time release.

ConsiGma™ was developed in compliance with the FDA’s QbD initiative. It satisfies the industry’s need for reduced risk and higher quality while avoiding lengthy and costly validation and scale-up to bring products to market faster and cheaper. The inherent flexibility enables manufacturers to meet demand, keep expensive cleanroom space to a minimum and reduce inventory costs.

From a quality perspective, much more intensive process monitoring and control allows operators to proactively address deviations from normal operating parameters and, as a result, run a more stable and consistent process.

In summary, the ConsiGma™ “ticks so many boxes,” be they continuous quality verification, flexibility, improved energy efficiency, or faster time to bring products to market, all factors which reduce cost for our customer base.

What are some of the areas where GEA is currently working to innovate and develop new manufacturing technologies?

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One focus area is in miniature, modularity and mobility. GEA recently completed a “future facing” collaborative project with three industry partners wherein we developed a Portable, Continuous, Miniature and Modular (PCMM) manufacturing platform based on our ConsiGmaTM Continuous oral solid dosage technology. The PCMM technology represents a completely self-contained and mobile continuous manufacturing system that can be transported to geographical areas of need, and installed within days to produce as much or as little drug as required, whether for product development, clinical trials, or commercial production. When production is no longer required, the unit can just as easily be disassembled and transported to another site. This agile concept for continuous manufacturing could feasibly make huge, purpose-built production plants a thing of the past, significantly reducing capital expenditure and operational redundancy. And with industry driving to reduce costs, increase quality and focus on patient-centric manufacturing, GEA believes that PCMM manufacturing will become the industry standard platform for processing OSD therapeutics.

Another potential area that we’re working with our partners to develop new technologies for is the interface between primary and secondary manufacturing. Increased focus on the API and particle characteristics may enable the removal of certain secondary process steps — such as high shear mixing and fluidized bed drying — and increasingly go directly from API to tableting.

How much investment are you seeing in more advanced manufacturing technologies in the APAC region?

There is huge diversity within the APAC region, and even within some of the individual countries. India, for example, has a very robust and extensive pharma export sector that supplies the US market. Here, we’ve seen significant investment in GEA solid dosage technologies and recent interest in the CM arena. However, companies targeting the domestic market still operate according to different standards within a less developed regulatory framework.

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Japan and South Korea are also very developed markets with strict regulatory requirements. With a focus on quality, this has driven a very strong interest in more advanced manufacturing technologies for OSDs, such as the ConsiGma™ technology platform. As a result, Japan has become a key focus for CM in many ways — because of their extremely high quality standards and a business culture that actively encourages an inherent quality and efficiency focus. Singapore is an important market in the sense that it is the regional hub for South East Asian Pharma, however the majority of investments in Singapore occurred seven to eight years ago.

On the biopharma and liquid pharma front, we’ve seen huge investments in both South Korea and Singapore, where leading multinationals have financed large-scale bioprocessing facilities.

That said, we’re now starting to see some interesting activity in markets that have previously been ‘white spots’ on the GEA map, including both Vietnam and Indonesia, where we’ve recently received some fairly large orders.

As an innovative, high tech manufacturing equipment provider, what is your value proposition to manufacturers in emerging markets?

GEA is a high quality, high tech, performance focused technology solution provider. Many of our clients realize and appreciate the value of our platforms for both specific, often complex applications such as oncology or potent molecule production, but also for large volume generic applications such as Metformin. The end-to-end solutions we offer for many of these processes are extremely effective and well worth the investment for manufacturers in any region.

One trend we’ve seen is an increased political priority to manufacture products locally. It’s possibly linked to the rising tide of nationalism in many countries around the world; but, throughout APAC, a number of projects have been driven by a stronger requirement to provide a local supply of essential drugs.

How would you assess GEA’s footprint in the APAC region, and what steps are you taking to further develop business in the region?

The situation is rapidly changing. Until recently, GEA has been a relatively Eurocentric organization. Our first big steps into APAC were in the mid 2000’s when we established strong local presence in both China and India. Since then, we’ve built a strong team and increased our share of the both key markets. Of course, we have representation in the more advanced markets, including Japan, South Korea and here in Singapore, but there are many white spots across the APAC region that we are only now beginning to fill in.

During the last two years, GEA has undergone a successful reorganization to strengthen its “customer-centric” presence globally and throughout APAC. As such, we now have strong country organizations that are responsible for local sales, service and customer relationship management. My regional team here in Singapore provides detailed quotations and develops and executes customer-specific solutions. With this setup in place, we are now well prepared to capitalize on the business opportunities in the region, and drive ambitious business growth in APAC for GEA.

Are your clients generally aware of the reorganization that GEA has completed to be closer to clients across the APAC region?

Since we completed the reorganization, communication and changing the perceptions of our market has been a primary challenge. Although the pharma industry across APAC is aware of GEA and recognizes our brand and products — which they associate with top-of-the-line quality and technology — many still question our regional and local presence, and our ability to provide the required levels service and support. Our country organizations have been very active, spreading the word that we have increased our local presence to address these concerns, and that GEA is more accessible than ever before in the APAC region. We have also been doing our best to network and make use of the fact that the pharma industry is a relatively close community — even across international borders.

How important is it for GEA to have a strong presence in Singapore?

Singapore is an important market for GEA for a variety of reasons. First, we have a significant base to support here, and if the growth of Singapore as a globally recognized pharma hub continues, it will remain an important market for us. Second, from a business and networking perspective, it’s critical to be present in Singapore alongside the regional headquarters of many of our clients, where many important decisions are made.

Plus, because it’s one of the hotspots of innovation and R&D across APAC, Singapore is a very interesting place to be. Big Pharma has an R&D presence here, and with government research incentives being offered, we may see much more. Being able to participate in Singapore’s innovative life science ecosystem is quite important for GEA; as such, I will actually be meeting with Professor Paul Heng from Singapore National University to discuss our participation in a potential collaborative R&D project.

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