Innovacell AG

Innovacell is a biotechnology company focused on developing, producing and marketing cell therapies for treating fecal and urinary incontinence. Technologies for isolating, multiplying, using and delivering muscle cells have been developed. Associated patents have already been granted or their applications filed.

Innovacell works according to the rules of “Good Laboratory Practice” (GLP), “Good Manufacturing Practice” (GMP) and “Good Clinical Practice” (GCP). These guidelines ensure that internationally recognized quality standards are met while developing, manufacturing, processing, packaging and storing pharmaceuticals and that customers and patients receive products of the highest quality.

Innovacell is one of the largest producers of autologous (endogenous) in vitro multiplied cells in Europe. Capacity is between 500 and 5,000 units per year, depending on the cell type.

Automation of manufacturing processes is in development. There are two main objectives:

Capacity required in the commercialization phase shall be built up step by step (scale-up).
This capacity shall be divided between five production plants, two in the EU, two in the USA and one in Japan, using a decentralized manufacturing and distribution model (scale-out).
Innovacell has approval to manufacture cell therapy test material for clinical studies. This includes currently the following cell types: autologous skeletal muscle cells, skin fibroblasts, and hair follicle cells.

Innovacell aims to market the products it has developed in the five key European countries (Germany, France, Italy, Spain and the United Kingdom) as well as in Japan and the USA. The goal is to become a global leader in the field of regenerative medicine with a focus on innovative, personalized cell therapies.