Five minutes at CPhI worldwide with …
Chemistry Today/ PharmaHorizon: You recently merged with WuXi AppTec. How is the integration going and what will it mean for STA?
Yu Lu: We recently merged with WuXi’s Pharmaceutical Development Services (PDS) division – which offers pre-formulation development, formulation development, as well as Clinical Trial Material (CTM) manufacturing, packaging and labelling of oral solid dosage forms including tablets, capsules, sachets and oral solutions/suspensions.
This allows us to provide fully integrated small molecule Active Pharmaceutical Ingredient (API) and drug product solutions, resulting in a seamless Chemistry, Manufacturing and Control (CMC) working process. This is yet another step forward in STA Pharmaceutical becoming a fully integrated CDMO.
Currently we can only undertake clinical trial supply manufacturing, however we are opening two commercial oral solids production sites in Wuxi city and Shanghai Waigaoqiao free trade zone in order to cover the entire finished product supply chain.
CT/PH: You opened a new transition metal catalysis center in Changzhou. What can you tell us about it?
Yu Lu:The center will be a part of STA’s integrated small molecule process development and manufacturing platform. The new state-of-the-art facility will enable STA to carry out rapid screening of metal catalysts, ligands, bases, acids, chemical resolving reagents, and amide formation coupling reagents, etc. The technology will allow our scientists to more rapidly find the optimal catalysts using a parallel interactive testing approach.
CT/PH: As a small molecule API CDMO, do you feel pressure from the rise of biologics?
Yu Lu: No, not at all – we partner with our sister company WuXi Biologics in the antibody drug conjugates (ADC) field which has been growing in parallel with monoclonal antibodies and other large molecule technologies. Our expertise in small molecule toxins and linkers is invaluable to the dual approach of ADCs.
CT/PH: You offer flow chemistry. Yet some players in the industry think this technology is not mature yet. What is your answer?
Yu Lu: In this context we are talking about continuous manufacturing of API’s, not finished dosage. The view that this technology is not yet mature and is still a ‘luxury but impractical tool’ is out-dated and certainly not one we believe in. For flow chemistry to deliver on its huge promise, pharma and CDMOs need to build the platform into the early phase process R&D of innovative API programs. This requires commitment from the very beginning of a project. We’ve seen a huge rise of interests from our customers and wider adoption rate this year. It’s only a matter of time until much more flow work is outsourced, and we have kept strengthening our internal flow chemistry platform in anticipation of this.
CT/PH: What can we expect from STA in the next year?
Yu Lu: You can expect to see STA continue to invest and enhance our capability and capacity, in both API and finished dosage areas. Our merger with the WuXi PDS division this year and investment in the new transition metal catalysis center are a good indication of what we’re moving towards over the next few years at STA. Our goal to become a ‘one-stop-shop’, and fully integrated CDMO is now beginning to take shape. Furthermore, it is likely that STA will see a steady rise in activity with companies utilizing the Marketing Authorization Holder pilot program in China. Following the success of the MAH’s launch (we already have 8 programs in place), we expect to begin programs with our US and EU customers planning to launch their innovative drugs in China and, likewise, see more of our Chinese customers looking to launch their innovative drugs in the West.
We have a vast amount of clinical stage drug candidates in the pipeline, and we will see customers more and more staying with us for clinical trial materials supply and throughout their development lifecycles. Finally, we also expect to see a number of customers’ Phase 3 compounds making it to full commercialisation in 2018.
CT/PH: What makes STA unique compared to other CDMOs?
Yu Lu: Many contract services provides claim to be working towards becoming a truly fully integrated CDMO – a term that recently has been thrown around quite a lot recently. However, at STA, we have a very strict definition of what this is and what it means. The first part is integration in terms of geography, for example our global footprint in the US and China, and our parent company – WuXi AppTec – and their global reach, means we are not limited geographically for any of our customers. The second part is integration of staff skill sets – we have a very large workforce behind our operations along with over 1,000 scientists, which covers an extremely broad range of expertise. Finally, the integration across technology is extremely important – our platforms are not limited by technology capabilities as we have thoroughly invested in a range of new and advanced techniques – for example our capabilities across the board in flow chemistry, biocatalysis, transition metal catalysis, HPAPI manufacture and even ADCs. A CDMO lacking in any part of these is not truly integrated.
As an example – at our Changzhou facility in China, we can take an API from preclinical to commercialization (including process R&D and manufacturing), all on one site.