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“Catalent perceives the next major market opportunity in South Korea”

29 June 2016 | Influencers | By BioSpectrum Bureau

“Catalent perceives the next major market opportunity in South Korea”

To begin with, could you give our BioSpectrum readers a short description about Catalent?
Combining world-class talent with cutting-edge technology, Catalent was created in April 2007 when The Blackstone Group, a premier global investment and advisory firm, acquired the Pharmaceutical Technologies and Services segment of Cardinal Health. The acquisition created a global network of experts and facilities dedicated to the advanced development, delivery, and supply of drugs and consumer health products.

Today, Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years' serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs more than8,500 people, including over 1,000 scientists, at 31 facilities across 5 continents, and in fiscal 2015 generated more than $1.8 billion in annual revenue. Its headquarters are in Somerset, NJ, in the United States.

What is Catalent's USP and how have your products/technologies disrupted the life sciences market?
As experts in improving drug performance, Catalent is globally renowned for bringing numerous innovations to market. Following the invention of the continuous softgel manufacturing process by RP Scherer in the 1930s, Catalent's softgel capsules have gained widespread acceptance and are now the preferred dose form for many prescribed drugs, OTC medications and health supplements. Catalent has continued the development of this flexible delivery technology for over eight decades, including the 2001 launch of Vegicaps, a vegetable-based softgel shell system.

In the 1980s, Catalent introduced its Zydis technology, a unique Orally Disintegrating Tablet (ODT) technology, which is a freeze-dried oral dosage form that disperses instantly in the mouth, requiring no water.

Further innovations have included the introduction of Catalent's proprietary GPEx technology, which creates stable, high-yielding mammalian cell lines with high speed and efficiency, getting customer's drug development projects to clinic in one-third the time of traditional approaches. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, to commercial scale production.

 

Catalent's OptiForm Solution Suite was introduced in 2015, and combines both predictive and high throughput screening technologies to identify the most stable and efficient drug form for small molecules. Expanding the scope of the solution to encompass macromolecules, OptiForm Solution Suite Bio employs a parallel screening model based on rigorous science and best-in-class formulation expertise, together with Catalent's proprietary OptiGel Bio and Zydis Bio drug delivery technologies, to deliver in vivo study material in as little as three weeks.

Catalent serves the needs of global clinical trial sponsors with services including comparator sourcing, secondary packaging and labeling, clinical storage, distribution, project management and clinical supply management. As well as the recently opened facility in Kakegawa, Japan, Catalent has clinical supply facilities in the US, UK, Germany, Singapore, and China, and an extended network of over 50 audited depots. Catalent's team has the capability and expertise to handle a broad range of international compliance and distribution requirements, which can help to expedite clinical trials and ensure that customers are reliably supplied where and when needed around the globe.

Could you explain about the company's presence in APAC? How do you perceive the market in APAC and how has the business grown in those countries?
Catalent's strategic investment in its Asia-Pacific clinical supply network has been implemented in response to growing demand from local and multinational sponsors, and reflects the trend towards more sophisticated storage and handling needs, more frequent and larger global studies, and more efficient supply models , especially where expensive drugs or limited trial materials are available.

Its expanded Singapore hub is GMP approved across all its activities, including secondary packaging, label printing, storage, distribution, returns and destruction management.

As you are aware, in Japan, Catalent has just introduced clinical supply services at its 200,000 sq. ft. facility in Kakegawa, where it also has a dedicated laboratory that provides proof-of-concept support and feasibility studies for Catalent's Zydis technology. The facility will provide full service solutions, including project management and clinical supply management, comparator sourcing, secondary packaging and labeling, clinical storage, distribution, and drug return and destruction. The site also houses expanded manufacturing capacity for its OptiGel Micro softgel technology.

Catalent's Shanghai facility was the first in China to provide end-to-end clinical supply solutions from clinical supply management, comparator/reference product sourcing and primary packaging, to clinical storage and distribution. In 2015, Catalent quadrupled cold chain capacity at the site, and installed dedicated receiving, dispatch and packaging areas.

The Asian facilities integrate into Catalent's global clinical supply network, enabling handling of a broad range of international compliance and distribution requirements and expedition of reliable clinical trials.

What made Catalent open a new supply facility in Japan? Could you also mention about the business in Japan and Australia?
The site will serve the needs of both domestic and global clinical trial sponsors with services including secondary packaging and labeling, clinical storage, distribution, project management and clinical supply management, and will complement the capabilities of other Catalent facilities in the Asia-Pacific region.

There is significant demand for Catalent's clinical supply services in Japan and across the Asia-Pacific region, and we built this facility with our new FastChainTM, Demand Led Supply model in mind, to bring customers greater speed and flexibility in their clinical supply chains. We are proud of the dedicated team that brought this facility online, and look forward to the first projects starting there later this month.
Catalent's Kakegawa facility and Braeside, Australia facility also have softgel and hard capsule manufacturing operations plus packaging capabilities.

Does Catalent see more opportunities coming from developing countries in Asia? If Yes, Which are those countries and why?
From a clinical supply perspective, the APAC region continues to grow in general and we see the next major market opportunity as being in South Korea, where we have now partnered with Howard Kim of PLS LLC to further customer relationships and spearhead business development activities. Kim will focus on matching the drug development, delivery and supply needs of Korean life science customers with Catalent's extensive global capabilities, technologies and expertise to help them explore opportunities to deliver better treatments to local and international markets.
Growth in this market has largely been fueled by an increasing number of clinical trials as well as a very active biologics sector. Additionally, in China and Japan, we are seeing changes in legislation and other initiatives designed to attract medical research, which should make these markets more accessible for sponsors to undertake their clinical trials in terms of both shorter review periods and approval timeframes.

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