Key Advanced Intermediates

It is known that the strategy of many Pharma Companies that have their own chemical production plants is to outsource the production of key advanced intermediates on an exclusive basis.

Helsinn’s three chemical plants support our partners in:
NCEs (New Chemical Entities): chemical development and production of their key advanced intermediates at the highest quality level.
Products already on the market: as a first or second strategic supplier, Helsinn can also support its partners in the search for improved processes and/or possible cost optimization.

Switzerland and Ireland have a worldwide reputation for high quality standards; therefore it might be assumed that Helsinn produces only high cost products. However, in our experience our clients recognize that the key is not price but value for money and hence they are using us to provide them with their outsourced cGMP key advanced intermediates. Through its supplier network Helsinn also works to obtain best price high quality starting materials worldwide and passes on this value to its clients. Helsinn Chemicals SA and Helsinn Chemicals Ireland Ltd. Are ideal for manufacturing up to multi-tons of products.

Active Pharmaceutical Ingredients (APIs)

On the other hand, although the medium-to-small sized Pharma Company is usually strong in drug substance/drug product R&D, its production focus (if any) is usually concentrated on the Drug Product, rather than on the API.

The Small Pharma Companies and start-ups are strong in R&D only and need to rely entirely on contract manufacturers in order to receive the material for clinical trials, registration and launch. Their need is to have the support of specialists in Drug Substance and Drug Product development and production taking care of all aspects of the API/DP (process analytical and physical-chemical characteristics, ) and support them with a robust service package that will make them successful whether they are launching directly the NCE or licensing-out to a Big Pharma. The value of Helsinn’s work has been recognized during several due diligences by large pharma companies evaluating the CMC of the API developed by Helsinn for the small biotech pharma companies. One particular aspect has been the fact that Helsinn has its own Drug Product facility producing solid dose and topical drug products based in Ireland and the know-how from this activity is also available to third party clients so optimize the Drug Substance to Drug Product transformation. This can include working with the DP service provider to ensure that all the API characteristics are appropriate. In fact Helsinn’s API site in Ireland which is co-located with the Drug product facility has developed a know-how and expertise in physical property characterization and manipulation which has proven valuable to clients who want to optimize this aspect whether for intermediates or API’s.

Here again Helsinn is strong in all activities related to the registration and launch of NCEs (New Chemical Entities) with commercial production. For products already on the market, Helsinn has been selected as first or second strategic supplier by several partners. This is because of its reliability in reproducing their APIs with the same impurity profile and physico-chemical characteristics with either the identical or an improved process.

All three manufacturing units, Helsinn Chemicals SA, Helsinn Advanced Synthesis SA and Helsinn Chemicals Ireland Ltd are ideal for manufacturing up to multi-tons of products.