Clinalfa® is Bachem’s brand name for its sterile products to be used in approved clinical studies. The products are manufactured and released based on the requirements laid down in the relevant European Commission Directives. Clinalfa products contain active substances manufactured and released according to ICH Q7. The investigator and/or sponsor shall be fully responsible for the intended use of the Clinalfa products, especially for judging the fitness of the products for such use, and for obtaining all respective legally required authorization. Bachem takes no responsibility for the safety and efficacy of the products.

The following Clinalfa product lines are available from Bachem:

• Clinalfa basic products are sterile freeze-dried products. The supply of Clinalfa basic products is accompanied by Bachem’s Certificate of Analysis (CofA) signed by Bachem’s Qualified Person (QP). The manufacturing process and the analytical methods might not be fully validated and only limited stability data are available. For more information click here. Various Clinalfa basic products are available from stock.

• Clinalfa plus products are sterile freeze-dried products or ready-to-use liquid formulations. In many cases, the used active pharmaceutical ingredients (APIs) and the resulting Clinalfa products are proprietary products of Bachem’s customers. Based on agreements between the customer and Bachem, Bachem’s Qualified Person (QP) may release the products for use in a specific clinical study approved by the competent authority. The level of validation of the manufacturing process and analytical methods, the design and duration of post-stability studies and the content of CMC documentation of Clinalfa plus products need to be customized to the developmental stage and intended use of the products. For more information click here.

• Clinalfa services: Related services to Clinalfa basic and Clinalfa plus products, i.e. formulation development, non-sterile tox-vials, compatibility studies, stress test and post-release stability studies, CMC documentation for IMPD and IND and other services, are offered under the Clinalfa service product line. For further details, please contact us.

Clinalfa basic and Clinalfa plus products are sold exclusively to “Authorized Persons and Companies”. Clinalfa products are manufactured and released by Bachem Distribution Services GmbH, Weil am Rhein, Germany. Please have a look at the respective manufacturing license and certificate of GMP compliance. For offers and supply of Clinalfa products and Clinalfa services, the General Conditions of Sale of the Bachem Group apply.

Note. Since July 1, 2007 Bachem is the exclusive owner of the Clinalfa® brand.