Helsinn [ company website ]

Helsinn is a leading Swiss CMO located in Biasca, Switzerland with over 30 years of experience in chemical development and cGMP manufacturing. Helsinn serves small to large biotech and pharmaceutical clients, supporting analytical and process development, manufacturing scale-up, optimization, registration and validation for mid to late stage clinical and commercial compounds. While focusing on synthetic NCEs, Helsinn performs a wide variety of services and chemical syntheses (see those called out below).

In addition to advanced intermediates and traditional small molecules, Helsinn has developed deep experience and strong competency in high containment manufacturing. Biasca possesses world class segregated facilities capable of handling highly potent, highly active, cytotoxic and other bulk drug substances that require specialized expertise, and appropriate containment equipment. Helsinn has over 15 years of experience with HPAIs (or HPAPIs) and the recent expansion of the new CYTO facility now offers fully segregated development and manufacturing for this special class of compounds. Helsinn offers comprehensive CMC services including regulatory and pharmaceutical support for all API needs. The production plants have a very successful global audit and inspection record with partners and regulatory agencies alike. Helsinn has been inspected by the FDA, Swiss Medic, PMDA, and the Korean agency. Helsinn’s most recent audit and PAI was April 2014 by the FDA with no 483 observations. Production scales range from hundreds of grams up to tens of tons for APIs in fully dedicated cGMP plants. Capabilities and Helsinn services are customized according to client needs on an exclusive basis.

Helsinn services Include, but not limited to:

• Clinical and commercial manufacturing
• CMC update and annual review
• Registration and process validation
• Batch record translation
• Route optimization
• Define all specifications & develop methods
• Supply chain management & sourcing
• Reference standards
• Ongoing stability
• Risk assessment

Hengdian Group [ company website ]