Helsinn Advanced Synthesis focuses on process development and scale-up for exclusive cGMP manufacturing offering comprehensive support services for small and large pharmaceutical partners developing new chemical entities (NCEs)
Based in Biasca, Switzerland, Helsinn Advanced Synthesis (HAS) is the chemical manufacturing division for The Helsinn Group located in nearby Lugano. HAS manufactures on an exclusive basis, clinical to commercial Intermediates, Active Pharmaceutical Ingredients (APIs), Highly Potent Active Pharmaceutical Ingredients (HPAPIs), and Cytotoxic compounds.
HAS’ core competency centers around effective process development and optimisation. With an experienced and highly trained staff, HAS offers full analytical and regulatory support, including method development, process and method validation, and CMC support up to and including NDA submission. The Helsinn project teams provide superior Customer Service and integrated Project Management as an extension of your own analytical, R&D, and CMC regulatory teams.
The production facilities have been successfully audited and approved by the FDA, Swissmedic, EMA, and PMDA authorities. Production scale ranges from KGs to several MTs for traditional, organic compounds. For HPAPIs, the production scale ranges from grams up to hundreds of KGs.
HAS has steadily grown over the past two decades by consistently reinvesting in R&D and manufacturing capabilities. Several strategic investments have been made to increase production capacity while offering customers new technologies and increased flexibility. In 1999, HAS invested heavily in containment manufacturing capabilities to include pilot and commercial scale containment for HPAPIs.
Recently, HAS has leveraged world-class HPAPI facilities and a highly trained and competent workforce to expand its facility and services to offer completely segregated Cytotoxic Containment Production. This state-of-the-art facility, commissioned in 2011, will be validated and ready for production in three phases during 2012.
The first phase, estimated to be completed in May 2012 is a dedicated R&D and QC Laboratory with broad analytical and process development capabilities exclusively for Cytotoxic drug compounds.
The Pilot facility for small scale Cytotoxin production is targeted for completion in June 2012, representing Phase 2 of the expansion. Finally, the commercial facility (Phase 3) will be completed in late 2012 and fully validated for production in January 2013.
Come join Helsinn Advanced Synthesis in the Art of Pharmaceutical cGMP Manufacturing!