How CDMOs can support customers in China

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We spoke with Gordon Bates, President of the Chemical Division at Lonza Pharma & Biotech on the role of the multinational CDMO in China.

Could you start by telling us a little about your role at Lonza Pharma Biotech?


I am the President of the Chemical Division at Lonza Pharma & Biotech (LPB), based in Basel, Switzerland. Lonza Pharma & Biotech’s Chemical Division works with pharmaceutical & biotech companies across the small molecule value chain, from API and drug substance development, to particle engineering and bioavailability enhancement, to clinical trials and commercial manufacturing. Our team also designs, develops and manufactures Capsugel ® capsules, offering the broadest range of capsule polymers, sizes and designs.

I am extremely proud of the work my team does helping solve drug development, delivery and encapsulation challenges for our customers by helping to create innovative small molecule products and life-saving therapies.

I’ve worked at Lonza for 15 years. Prior to my current position, I worked in roles that focused on large molecule drug development and manufacturing.

Lonza will have a presence at CPhI China this year, why is China an interesting market for you?

At Lonza, we believe we can add value across the Chinese pharma market because of our heritage in the region and the breadth of our offering. We have worked in Suzhou, China, for thirty years through our Capsugel presence, and have built substantial brand equity and understanding of the market’s needs as a result. We’re proud that Lonza has been a constant in the changing Chinese market over the past several decades, delivering high-quality products and services grounded in precision science and engineering.

At the same time, we offer end-to-end services to innovative companies in China and around the world. Since 2003, through our Nansha site, our offering extends from API manufacturing and drug substance development, to bioavailability enhancement and accelerated API development for first-in-human testing, to finished dosage forms, clinical trials and commercial manufacturing. We can work with customers across the development spectrum – or come in to offer specialized services for specific challenges. For example, we recently launched SimpliFiH™ Services, an integrated API and drug formulation package specifically designed to address bioavailability challenges and accelerate the development of innovative small molecules to first-in-human clinical trials.

What are the current trends in Chinese Pharma? Any particular therapeutic areas of interest?

China is quickly developing and evolving into a market for selling CDMO services. China-based innovators and generic companies alike are looking to external CDMOs as partners that can provide drug development solutions that can be quickly developed and moved to market. They recognize that relatively few products will make it all the way to commercialization. Successful companies also understand the importance of their CDMOs having regulatory knowhow and expertise.

Demographic trends mean that particular therapeutic areas – such as pulmonary and geriatric disease – are growing more quickly than others in China. Many pharmaceutical and biotech firms are focusing on drugs and treatments that address pulmonary disease – for example, capsule-based dry powder inhalation (DPI) products.

Lonza recently launched our new Capsugel® Zephyr™ portfolio, an end-to-end inhalation drug development and manufacturing service spanning particle engineering – including micronization and spray-draying – to formulation and encapsulation for use in capsule-based DPI devices. We developed this integrated product and service offering to enable consistent and optimal release performance for inhalation drugs – for example, those being developed by innovators in China and elsewhere.

Are there any challenges from a legal or regulatory perspective that you’ve encountered?

Given our long-time presence in the Chinese market, Lonza has been able to keep a consistent finger on the pulse of regulatory and legal landscape in China. We believe we understand and can adjust to regulatory changes quickly to stay ahead of the curve. For example, as China has incorporated more regulations in terms of pharmaceutical product quality through what is called consistency evaluation program, we have been able to support our customers almost instantly since our products already exceeded global quality requirements.

What is the role of the international CDMO in China currently?

We believe there are many benefits for Chinese companies that we bring to the table due to our global footprint. For example, our worldwide presence means we can incorporate global learnings into our work with local companies and ensure best practices and expert counsel from API manufacturing to drug product development, clinical trials and commercialization.  

Despite being a global CDMO, we have emphasized growing our presence and capabilities in China. Our Nansha site for chemical API manufacturing, established in 2003, has state-of-the-art facilities, development services and advanced pharmachemical manufacturing processes. In December 2018, Lonza announced the commissioning of a new biological site in Guangzhou. The site will be operational in 2020 and will offer Lonza’s suite of mammalian expression technologies, supporting customers from cell line development through to clinical and commercial cGMP batch production.

Now the contract manufacturing market is opening up, what do you see as the long-term opportunities?

As China becomes a greater consumer of healthcare, as well as the source of more and more innovative pharma companies, the role of the CDMO in supporting that growth will only become more pronounced. CDMOs with global experience, capabilities and reach will be best positioned to serve those companies.

In addition to global capabilities, experience in and knowledge of the Chinese market is extremely important. At Lonza, we have decades of experience in China and believe it continues to be an important differentiator appreciated by our customers in the country.

We look forward to continuing to grow our presence in China and work with increasingly diverse companies.

Could you start by telling us a little about your role at Lonza Pharma Biotech?

I am the President of the Chemical Division at Lonza Pharma & Biotech (LPB), based in Basel, Switzerland. Lonza Pharma & Biotech’s Chemical Division works with pharmaceutical & biotech companies across the small molecule value chain, from API and drug substance development, to particle engineering and bioavailability enhancement, to clinical trials and commercial manufacturing. Our team also designs, develops and manufactures Capsugel ® capsules, offering the broadest range of capsule polymers, sizes and designs.

I am extremely proud of the work my team does helping solve drug development, delivery and encapsulation challenges for our customers by helping to create innovative small molecule products and life-saving therapies.

I’ve worked at Lonza for 15 years. Prior to my current position, I worked in roles that focused on large molecule drug development and manufacturing.

Lonza will have a presence at CPhI China this year, why is China an interesting market for you?

At Lonza, we believe we can add value across the Chinese pharma market because of our heritage in the region and the breadth of our offering. We have worked in Suzhou, China, for thirty years through our Capsugel presence, and have built substantial brand equity and understanding of the market’s needs as a result. We’re proud that Lonza has been a constant in the changing Chinese market over the past several decades, delivering high-quality products and services grounded in precision science and engineering.

At the same time, we offer end-to-end services to innovative companies in China and around the world. Since 2003, through our Nansha site, our offering extends from API manufacturing and drug substance development, to bioavailability enhancement and accelerated API development for first-in-human testing, to finished dosage forms, clinical trials and commercial manufacturing. We can work with customers across the development spectrum – or come in to offer specialized services for specific challenges. For example, we recently launched SimpliFiH™ Services, an integrated API and drug formulation package specifically designed to address bioavailability challenges and accelerate the development of innovative small molecules to first-in-human clinical trials.

What are the current trends in Chinese Pharma? Any particular therapeutic areas of interest?

China is quickly developing and evolving into a market for selling CDMO services. China-based innovators and generic companies alike are looking to external CDMOs as partners that can provide drug development solutions that can be quickly developed and moved to market. They recognize that relatively few products will make it all the way to commercialization. Successful companies also understand the importance of their CDMOs having regulatory knowhow and expertise.

Demographic trends mean that particular therapeutic areas – such as pulmonary and geriatric disease – are growing more quickly than others in China. Many pharmaceutical and biotech firms are focusing on drugs and treatments that address pulmonary disease – for example, capsule-based dry powder inhalation (DPI) products.

Lonza recently launched our new Capsugel® Zephyr™ portfolio, an end-to-end inhalation drug development and manufacturing service spanning particle engineering – including micronization and spray-draying – to formulation and encapsulation for use in capsule-based DPI devices. We developed this integrated product and service offering to enable consistent and optimal release performance for inhalation drugs – for example, those being developed by innovators in China and elsewhere.

Are there any challenges from a legal or regulatory perspective that you’ve encountered?

Given our long-time presence in the Chinese market, Lonza has been able to keep a consistent finger on the pulse of regulatory and legal landscape in China. We believe we understand and can adjust to regulatory changes quickly to stay ahead of the curve. For example, as China has incorporated more regulations in terms of pharmaceutical product quality through what is called consistency evaluation program, we have been able to support our customers almost instantly since our products already exceeded global quality requirements.

What is the role of the international CDMO in China currently?

We believe there are many benefits for Chinese companies that we bring to the table due to our global footprint. For example, our worldwide presence means we can incorporate global learnings into our work with local companies and ensure best practices and expert counsel from API manufacturing to drug product development, clinical trials and commercialization.  

Despite being a global CDMO, we have emphasized growing our presence and capabilities in China. Our Nansha site for chemical API manufacturing, established in 2003, has state-of-the-art facilities, development services and advanced pharmachemical manufacturing processes. In December 2018, Lonza announced the commissioning of a new biological site in Guangzhou. The site will be operational in 2020 and will offer Lonza’s suite of mammalian expression technologies, supporting customers from cell line development through to clinical and commercial cGMP batch production.

Now the contract manufacturing market is opening up, what do you see as the long-term opportunities?

As China becomes a greater consumer of healthcare, as well as the source of more and more innovative pharma companies, the role of the CDMO in supporting that growth will only become more pronounced. CDMOs with global experience, capabilities and reach will be best positioned to serve those companies.

In addition to global capabilities, experience in and knowledge of the Chinese market is extremely important. At Lonza, we have decades of experience in China and believe it continues to be an important differentiator appreciated by our customers in the country.

We look forward to continuing to grow our presence in China and work with increasingly diverse companies.