Strong Start - After beginning its investment in a brand-new cytotoxic molecule facility in Biasca, Switzerland, in 2011, Helsinn started production in July 2012. Now one and a half years later, Brandi Schuster spoke with Waldo Mossi, Senior Director of Business Development, Helsinn Advanced Synthesis, about developments in demand for cytotoxic molecules and upcoming trends.

CHEManager International: Helsinn opened up a new plant for cytotoxic molecules in 2012. How has the demand been for cytotoxic molecules since the plant began manufacturing?

Waldo Mossi: We have been very fortunate to see a steady and consistent demand for the cytotoxic facility since the first project kicked off in July 2012. The cytotoxic plant is segmented into three levels of production, a small, mid and large-scale. We have seen the highest demand in our large-scale facility where we manufacture tens of kilograms. Each production area was designed using state of the art closed system equipment with variable air pressure and engineering controls designed to protect HAS employees, the environment and our client's product integrity. The specific design and equipment can work with cytotoxic compounds meeting stringent OEL Limits down to 50 ng/m³.

What regions do you serve with this plant? In general, what parts of the world are of interest for Helsinn?

Waldo Mossi: As of now, all of our cytotoxic projects have come from the U.S. and Europe. However, we are seeing a lot of interest from Asia, so we anticipate future projects to come from that region as well. In general, we work with companies based in the U.S., Europe and Japan with the majority of projects coming from the US. Our main clientele consists of small to medium sized pharma where we provide the full CMC support for projects Phase II through commercialization. Our cGMP facilities in Biasca, Switzerland have been successfully approved by the Swiss and European authorities and US FDA (No 483s), as well as by the PMDA.

How has the demand for HPAPIs developed over the last few years? Where do you see the trend going?

Waldo Mossi: Helsinn started manufacturing HPAPIs in 1999. The HPAPI facility can handle selective anti-cancers with OELs down to 1 μg/m³. In the first facility, we were able to produce up to 10 kg of HPAPI. A few years later we expanded our offering to include production ranges up to about 150 kg. Similarly to what we are seeing in our cytotoxic facility, we are seeing a trend towards a growing demand of the large scale facility. As we anticipated when we built the cytotoxic facility, we are seeing a pharmaceutical trend of production segregation between cytotoxic compounds and HPAPIs with anticipation of future regulatory restrictions.

What challenges do you face as an API/HPAPI producer in Switzerland in terms of cost? How interesting are lower-cost areas for the company?

Waldo Mossi: We find that for the later-stage programs, our clients are looking for high quality material from a company with an exceptional regulatory inspection history over price. With that said, of course cost is something that still comes into play. In order to mitigate costs where we can, we optimize the use of our reactors with batch size so we can decrease the cost per kilo. Additionally, from a logistics perspective we have partnered with select companies in China, so we can bring down the cost of goods where it makes sense to source starting materials and earlier non-GMP steps where applicable.