“Regional manufacturing facilities crucial for suppliers”

Besides sharing his views on the current R&D trends, manufacturing practices and market scenario pertaining to biosupplier industry,  Mr Devashish Ohri, Executive Vice President, Asia/Middle East, Africa (MEA), Avantor in an exclusive interaction with the Biovoice News, also provided insights into his company’s India operations

What are the latest trends in raw material products and technology globally?

The global market for biologic-based therapeutics has greatly expanded over the last decade. The emergence of the biosimilar marketplace too has been significant. As a result, the number of commercial opportunities and technical challenges has increased. The biological systems used to manufacture these drugs are known to be inherently variable, a feature which has important consequences for the reproducibility, safety and efficacy of the resulting desired product.

Process insight and consistency are critical since slight changes can lead to adverse effects, such as immunogenicity, with potentially serious safety implications. In generating biosimilars, it is crucial to ensure that all clinically active attributes of the biotherapeutic, including protein post-translational modifications (PTMs), are accounted for and confirmed.

At Avantor, we are actively investigating one such PTM: protein glycosylation, which is the attachment of carbohydrates to a protein structure. It has been recognized that protein glycosylation can be a critical quality attribute for proteins used for discovery and biotherapeutics, as it often plays a key role in the efficacy, safety, stability and functionality of the protein. We are working to better understand and document the role of raw materials in the variability and control of this process.

Additionally, we are working with biopharmaceutical researchers and manufacturers to better understand how trace elemental impurities can impact the glycosylation pattern. Quality and consistency of raw materials is critical for managing the quality of biopharmaceutical product discovery and development, and it appears that engineering and reverse-engineering of carbohydrate attachment can prove a powerful tool in the field of biosimilars and protein-therapeutic engineering, as well as helping streamline Food and Drug Administration (FDA) approval processes.

How is Avantor helping to streamline production and eliminate variability in biopharma and pharma manufacturing?

We recently developed and introduced J.T.Baker High Purity Low Endotoxin (HPLE) sugars to help reduce variability and streamline production in biopharmaceutical manufacturing. These products are manufactured at our cGMP manufacturing facility in Panoli, Gujarat, India, using proprietary purification technology to achieve endotoxin levels that are below required thresholds to help reduce the potential for adverse chemical reactions. For example, J.T.Baker HPLE galactose contains significantly lower levels of trace metals when compared to standard galactose available through multicompendial sources. This is crucial for biopharmaceutical manufacturers with established cell culture processes that rely on highly controlled levels of metal in order to reach desired yield for a target molecule.

Another way we are helping our pharmaceutical customers streamline production is by offering innovative materials packaging options. The J.T.Baker Direct Dispense packaging system was developed in collaboration with our customers to deliver pre-weighed, free-flowing materials directly into their drug manufacturing processes. The size, shape, sealing and seams of the J.T.Baker Direct Dispense bags were designed so virtually all material, within a one percent threshold of the amount required, could be dispensed when the bag was inverted. Additionally, the transparent bags are compatible with near-IR testing, which eliminates the need to sample material for identification testing, and are designed to be single-use, which reduces the time and cost of weighing, subdividing and dispensing materials from bulk containers.

“Our Panoli facility is often viewed as a benchmark in the region and a benefit to the local community. Typically, it’s the case that after one multinational company has set up a quality facility in India or other emerging market, others usually have the confidence to follow.”

Finally, we have invested in our R&D capabilities to help advance global drug discovery, process innovation and productivity in these industry segments. Opened earlier this year in the United States, Avantor’s Bridgewater Innovation Center was designed to provide data-driven answers to our customers’ biopharmaceutical, biologic and small molecule challenges. The Center provides a portfolio of services and contract research organization (CRO) capabilities for life sciences customers, allowing us to operate as a highly focused, “rapid response” extension of our customers’ drug development efforts.

Our researchers are also focusing on finding answers to fundamental questions about the performance of Avantor’s own products, using data that characterizes how the company’s products impact customer processes. These efforts will help customers use Avantor’s chemistries in new ways to improve process development and final formulation, and fully leverage the benefits of a consistent, reliable supply chain.

What are the new functional excipient products and laboratory products launched by Avantor in India?

J.T.Baker brand PanExcea performance excipients were FDA approved in India in 2016. These excipients are manufactured using novel particle engineering technology and homogenous crystalline powders for improved control over processes, increased formulation flexibility and faster formulation development. Optimized to facilitate efficient manufacturing of immediate release drug formulations using direct compression, they can be directly formulated with all classifications of active pharmaceutical ingredients and accommodate dilution with auxiliary excipients, if needed.

How have the cGMP manufacturing facilities in India helped Avantor? Are you planning to have more such facilities in India?

In today’s globalized life sciences industry, many manufacturers in India and other emerging markets have dynamic needs. A supplier with a supply chain that lags behind for a few months may find that customer needs may change before it has the ability to adapt to them, which doesn’t match with the industry’s fast pace of innovation. This makes regional facilities crucial for suppliers because they can reduce the supply chain from months to weeks.

Avantor’s ISO 9001:2008 certified and Indian FDA approved Panoli facility has become an integral part of our supply chain, enabling us to be highly responsive to customer needs in India and neighboring regions as well as globally. Here, we manufacture many of our products, including J.T.Baker HPLE sugars, and leverage the same global quality and supply chain systems on which Avantor customers have depended for many years.

Our Panoli facility is often viewed as a benchmark in the region and a benefit to the local community. Typically, it’s the case that after one multinational company has set up a quality facility in India or other emerging market, others usually have the confidence to follow. In time, more manufacturing and quality hubs appear, creating jobs for the community and helping to raise standards throughout the region. The Indian FDA often sends representatives to look at our facility as an example of how to do things. And two years ago, we were very proud to have been awarded the National Safety Award for our plant operations in the category of Manufacturer of Chemicals and Chemical Products for the performance year 2015.

How do you view the current market scenario in India? What are the challenges and opportunities for bio-suppliers or technology providers?

India is the second largest supplier of generic drugs by value, and the largest supplier by volume to the global marketplace. Generic drugs in India include a broad range of small-molecule drugs, over-the-counter products, AIDS antiretroviral, oncology drugs and more. This includes the increasing number of development of large-molecule drugs, and especially generics as more innovative drug products come off patent.

In terms of quality, there is a tightening of regulations with major regulatory agencies, such as the U.S. FDA and UK Medicines and Healthcare products Regulatory Agency (MHRA), pushing for stricter norms for pharma companies not only in terms of manufacturing practices, but also where they source their ingredients or components. This is benefiting the industry in India in general, particularly as more and more multinational manufacturers like Avantor look to their Indian facilities as a key element in the global supply chains – not merely as a facility that serves the Indian market. Manufacturers of both small- and large-molecule drugs are being driven to partner with more reputable suppliers, rather than simply looking solely at price, which also pushes other suppliers in the region to migrate to higher standards to be competitive.

India is also working on some of the challenges that the rest of the global biopharmaceutical industry faces, like drug development and process optimization. These include achieving the efficient production of therapeutic proteins and discovering new approaches for maximum protein expression; developing economical, flexible and robust manufacturing processes; and improving formulations for better dosage, stability and injectability. Additionally, appropriately defined cell culture conditions are required to achieve maximum protein expression.

What are you addressing these challenges as a company to further boost your potential?

As noted before, we developed a portfolio of services and contract research organization (CRO) capabilities at our Bridgewater Innovation Center to help customers address these challenges. This includes engaging biopharma customers in areas where, in the past, they lacked the resources to explore, such as optimizing drug formulation, protein expression process engineering and scaling from pilot plants to full production. By having a collaborative, engaging approach to innovation with our customers, we may anticipate their emerging requirements and offer timely solutions to their challenges.

Finally, we are strengthening our ability to provide a full range of products, solutions and services to the global industries we serve through our recent acquisition of VWR, the leading global independent provider of product, supply chain and service solutions to laboratory and production customers. Avantor and VWR joined together as one company operating under the Avantor name. Our combined reach and direct channel access, customized logistics and product requirements, and strong local presence in both developed and emerging markets will allow us to fulfill our shared vision to be a trusted global partner to our customers and suppliers in the life sciences and advanced technology industries.