Helsinn Advanced Synthesis
Helsinn Advanced Synthesis SA is a full Service Contract Manufacturing Organization (CMO).
Holding a GMP certificate since 1984, production has been completely dedicated to products requiring cGMP, with a clear focus on serving the Pharmaceutical Industry. Helsinn Advanced Synthesis (HAS) has placed a high level of emphasis on our internationally renowned Quality System. HAS has also focused on sustainable production practices which protect the environment. Since early 2000, the plants have been ISO 14001 certified, as a part of Helsinn’s ongoing commitment towards international environmental protection. The continuous work on Health, Safety and Environment (HSE) also led to the OHSAS 18001 certification in 2005; we were one of the first chemical plants in Switzerland to achieve this status. In addition, the Helsinn Advanced Synthesis’ Sustainability report was approved by GRI (Global Reporting Initiative) and issued in 2012. Helsinn Group’s first Sustainability Report, approved by GRI and issued in December 2015, provides an updated situation of its production facilities in HAS. HAS has been consistently and successfully approved by the Swiss authorities and by the US, EMA and Japanese PMDA as well as by several other national boards, maintaining a flawless quality record. HAS has the capacity to produce APIs, HPAIs and Anticancer molecules with a huge range of different batch sizes, from tens of tons to a few grams, depending on the requirements. Continuous investments allow to increase production capacity and more importantly, to add new capabilities increasing production flexibility.
Active Pharmaceutical Ingredients and Advanced Intermediates
Helsinn is able to take on a wide range of clinical and commercial projects due to the large flexibility in reactor sizes for small molecule classical APIs.
cGMP Process Scale-up:
- Kg quantities in our cGMP scale-up plant (100 and 250 L reactors)
- Stainless steel and glass-lined reactors
- Process verification and fine tuning
- Master formula preparation
- Demonstration batch
- Clinical batches
- Registration batches
- Process-validation batches
- Commercial supply
- Milling and micronization
- Flexible range of 1,000, 2,000, 4,000, and 6,300 L reactors including a (-80°C) reactor for metal-organic chemistry
- Stainless steel, glass-lined and Hastelloy Isolation
- Horizontal peeler centrifuges
- Basket centrifuges
- Pressure filter
- The final processing step in API manufacturing meets the conditions for final dosage form production
- Bi-conical rotary vacuum dryer (2,000 L and 4,000 L reactors) ISO 8