FEATURE ARTICLE

Great constructions of China

Published: April 28, 2017

Dr Minzhang Chen, CEO of STA Pharmaceutical, explains how his company is taking contract development and manufacturing to a new scale. As Dr Chen said to us when we met during DCAT Week ‘17, “Remember, when we build a wall, we build a great wall!”

Shanghai-based STA Pharmaceutical has five sites – four in China and one in San Diego, California. While the company’s presence in the US might seem to follow a trend for companies headquartered in Asia seeking to expand into the US, it’s clear that STA’s focus is firmly on the homeland. Already employing more than 950 R&D scientists in two Shanghai sites alone, and with that number set to increase to 1250 within the next 2 years, the sheer scale of their endeavour is breath-taking. Their latest development – when finished in 2018 – will be home to 500 scientists and nine manufacturing plants. Sarah Harding (SH) spoke to Minzhang Chen (MC), CEO of STA Pharmaceutical. 

SH: The impressive size of STA’s R&D facility must reflect considerable demand for your services. Where is that demand coming from, and do you think it will be sustained in the future?

MC: Small molecule NCEs (New Chemical Entities) still make up well over half of the drugs pipeline globally and we have seen a steady increase in enquires over the last few years. This is driven by our growing reputation as the contract provider of choice for small molecule development and manufacturing services, alongside renewed targets emerging from the drug discovery pipeline. Particularly, as new drugs come into the development cycle with more complex chemistries and shorter development timelines. Overall, outsourcing will continue to rise as pharma reduces manufacturing capacity and virtual biotechs increase.

The facilities we have built and are building are a direct consequence of the growing demand we forecast. We are confident and excited about near and medium term growth. So yes, we are very bullish on the company’s prospects.

SH: What are your experiences dealing with the FDA and European authorities?

MC: We have a large amount of experience with regulators from both the EMA and FDA, as well as the CFDA in China and PDMA from Japan. However, it’s not just the regulators visiting and inspecting, as with over 100 NCEs in development there are very few weeks in which we are not undertaking an audit for a customer as well. The FDA has approved our commercial API facility in Jinshan, and we expect they will visit the newer site in Changzhou in 2017.

STA Pharmaceutical’s Changzhou site

STA is the first Chinese contract manufacturing organization to have received approval to supply active pharmaceutical ingredients (APIs) and GMP intermediates for branded commercial drugs from regulatory agencies in the United States, Canada, the European Union, Switzerland, China, Japan, Australia, and New Zealand.

SH: To find 1250 qualified scientists suitable for employment is – in itself – a challenge. How do you ensure that standards are maintained in the face of such demands for highly-qualified manpower?

MC: It’s through a combination of finding the right talent through our recruitment services and from in-house training and talent retention, which at STA is substantial. One of the great advantages we have in China is that, overall, the standard of science degrees are very high and we have a stable supply of highly qualified graduates. Our management team also has a large breadth of experience working in Western pharma companies so it's a really great mix of talent.

STA also works very hard to retain its best talent, and having nurtured such a strong and robust reputation, graduates and employees are increasingly looking to stay with us for a good part of their careers. It also helps as we are a clear industry leader in pharma and life sciences in China. Our staff remain very motivated and proud to work with us, as the WuXi AppTec and STA brand has a great deal of credibility. In fact, this number of in-house scientists remains our core business advantage.

SH: In your opinion, what are the most promising opportunities for the CDMO sector at the moment –in China and globally?

MC: Globally, there are several product classes that are showing a lot of growth – particularly across oncology with a steady pipeline of new targets coming through the drug development cycle. The other well-documented trend is for an overall reduction in the number of contract services providers. The most prosperous CDMOs will therefore need to be able to develop the more complex chemistries and compounds now coming through – but they must also ensure that they are capable of taking a product all the way through the development cycle. With this in mind, you are seeing a number of medium and large CDMOs making acquisitions to achieve both scale and specialist technologies. However, only the most ambitious of CDMOs are investing in building their own specialist facilities and this comes with the advantage of bringing the latest and most advanced technologies.

In China there is now a huge opportunity for contract manufacturing for the domestic consumption – thanks to the Market Authorization Holder (MAH) pilot program, which enables the drug license holders to use a different manufacturer for production. However, in the longer-term, clearly there is the possibility of other CDMOs to prosper through the STA model – building advanced CDMOs that target contract services for NCEs, whether in clinical development or commercial supply.

 

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