Wei-Hong Tseng, founder and chairman of PharmaCore Biotech, introduces the specialized CDMO and its unique capacities to produce high value-added products. As a leading service provider in Taiwan, Tseng goes on to explain the company’s future strategy to not only continue its international expansion but also further enhance its innovative production capabilities while ultimately expanding into the production and marketing of their own advanced portfolio.
By using our innovative manufacturing platform combined with exclusive sterile powder filling technology, PharmaCore not only creates larger batches but also reduces the production time at the same time
Please begin by introducing yourself and PharmaCore Biotech to our international readers.
I earned a PhD in organic chemistry synthesis from the National Changhua University. I have been in the pharmaceutical industry for over 20 years, working in different areas such as R&D, process development, manufacturing management, quality management, and regulatory affairs.
When I founded PharmaCore in 2015 our initially mission was to offer CDMO services. Moving forward, we decided to increase our drug development offering by expanding our production capabilities.
PharmaCore today has nine production lines across several different areas ranging from non-cytotoxic to cytotoxic products, non-sterile to sterile products, from small molecules to biomolecules, and API to injectables.
We have the ability to offer services starting from API production through product development and final dosage forms.
PharmaCore is one of the few CDMOs in the world that is capable of both sterile API and sterile lyophilized drug product manufacturing. Can you tell us more about your innovative production platform and the capabilities of your service offering?
PharmaCore is able to provide services from development research all the way up through commercial production. For cytotoxic products, we can produce both sterile and nonsterile APIs. In injectables, we have the capacity to product final dosage form products, lyophilized products, liquid and powder filling. Speaking about stable APIs, PharmaCore is the only company in Asia able to perform sterile powder filling.
Lyophilized products are more common that sterile powder-filled products, but there are limits to the batch size of lyophilized products and the production time is longer. By using our innovative manufacturing platform combined with exclusive sterile powder filling technology, PharmaCore not only creates larger batches but also reduces the production time at the same time. The labour and manufacturing costs can be significantly reduced. This not only provides benefits to the business but also the healthcare publics, which the pricy injectable products now become more affordable. Furthermore, we also have a specialized production line for Botulinum neurotoxin – one of five in the world.
Moving forward, PharmaCore’s business strategy is aiming to include the development and marketing of its own products on top of its API and CDMO service offering. What challenges do you expect to face in taking on this new business activity?
Yes absolutely, although the products we produce now are for CDMO purposes, we are aiming to begin using our niche expertise to build PharmaCore’s own market product portfolio. Primarily we are considering utilizing our capabilities in injectables and sterile APIs.
The major challenge we expect to face is the initial development time and expense it will take to get these operations running. Therefore, we will take our CDMO services as a base to support the preparation of activities. The second challenge is the technology needed to develop our own product line. Using our crystallization skill to achieve desired physical properties of the product, such as particle distribution, solubility and crystalline. This is the most critical aspect for creating powder filling injectable products.
PharmaCore was founded only four years ago in 2015. How is the company positioned in the market today and what strategies do you have to ensure future growth?
PharmaCore has 125 employees and achieved revenues of approximately USD 11 million. When PharmaCore was first established, we only had two production line – today we leverage nine. After only two years of operation, we were able to achieve TFDA PIC/S GMP and GDP certifications. This was a significant milestone for PharmaCore which brought more partners looking to collaborate with us as their CDMO of choice. Instead of fighting alone, we are team players. As we included more innovative product lines, we also began to leverage international strategies. PharmaCore has clients across the world in key strategic markets such as the US, Europe, India, Korea, Japan, central and south America. Looking forward, we aim to be accredited by the USFDA next year.
Do you feel competitive pressures coming from other API markets around the world known for producing low-priced products?
Not at all. Unlike China and India, we do not produce general, low-value APIs. As PharmaCore continues to grow internationally, sure will face more competitors. Therefore, we must be selective in the projects we take on – leveraging more complex, competitive production capabilities.
Pharmaceutical companies are increasingly transferring risk and price pressures to service providers, but also at the same time creating close collaboration and long-term partnership agreements. How do you view the relationship between pharma companies and CDMO service providers?
The key consideration is how service providers and pharmaceutical companies can better cooperate together. PharmaCore has a niche production line that they do not have, so our offering is necessary. This does not only apply to generic products, but to new drug development as well. Most new drug companies are only capable of carrying out research, they do not have their own production facilities making our services a necessity. PharmaCore has more than 60 business projects, the majority being in new drug development, whereas we have over 20 projects in the generics space.
How are you positioning PharmaCore to be a first mover in creating innovative manufacturing facilities?
The most important factor in creating advanced manufacturing processes in having the right people. Most of PharmaCore’s team comes from experienced backgrounds having worked in other Taiwanese CDMOs and pharmaceutical companies. We have all worked together to build up the company from all sides including R&D, engineering and quality management – where we have more than 150 active employees. Additionally, PharmaCore has established a long-term partnership with a GMP consultancy, PE PharmEng, for the support of continuous improvement of quality system.
What strategic priorities have you identified for PharmaCore in the upcoming five years?
We have several new projects launching in 2020 and 2021, so the next stage for the company will be focused on bolstering our revenue growth. Having more capital is a key component in laying the foundation for our own product portfolio development while simultaneously adding more production lines to our current capacity.
When your customers hear the name “PharmaCore”, what do you want them to think about?
PharmaCore’s name comes from the idea that the team that mastered the core techniques in the pharmaceutical field and will one day become the centre of pharmaceutical society!