Spain:
mAbxience León

Planta de desarrollo y producción de medicamentos bisosimilares de mAbxience en León (Castilla y León). mAbxience, compañía biotecnológica de medicamentos biosimilares

History

mAbxience León plant opened in 2015 with highly skilled professionals from all around the globe.
A young, dynamic and multidisciplinary team specialized in R&D, monoclonal antibodies, and the biotechnology industry.
 
 

 

Facilities

The León plant is the biggest biologic plant in Spain and the first in Europe with fully integrated single-use technology in most processes (cell bank, purification, formulation, culture and media & solutions preparation). The facility is equipped with R&D laboratories, Quality Control laboratories, GMP plant and GMP industrial plant.

Environmental & Risk Prevention Policies

 

Regulatory agencies approvals:

mAbxience León has the GMP certificate from EMA, AEMPS (Spain), ANMAT (Argentina), Turkish Ministry of Health and TGA (Australia Therapeutic Goods Administration) amongst others.

 

GH Genhelix, S.A. is currently carrying out its strategic plan for the development of Bevacizumab biosimilar (monoclonal antibody), which is partially financed by the Instituto de Competitividad Empresarial de la Junta de Castilla y León with the financial support of the European Union.