DIATHEVA is an Italian leading contract research and manufacturing organization for the biopharmaceutical, biotech and medical devices industries.
We provide fully integrated and personalized services for the production of recombinant proteins, monoclonal and polyclonal antibodies with a special emphasis on new immunogens, enzymes and antibody fragments, ensuring seamless transfer from cell line development through to large scale production and commercial supply.
DIATHEVA is also focused on the development of novel biologic therapeutics in oncology and infectious diseases areas.
We hold a state-of-the art GMP production facility authorized by EMA to produce and release biological APIs for preclinical and Phase I/II clinical studies.
Our capabilities include:
• Expression system & cell line development and optimization
• Production and characterization of master and working cell banks
• Process Development and scale up
• Analytical Development, Qualification, Validation
• Biophysical Characterization
• Microbial cGMP Manufacturing
• GMP APIs Release
• ICH – Compliant Stability Programs
The state-of-the-art facility spans 2200 m2 and has been designed with flexible capacity. The space dedicated for GMP production operations totals approximately 1000 m2. It houses a cellbanking production suite and four fermentation and purification suites equipped with microbial fermentors ranging in capacities from 20 L to 200 L. The purification suites are equipped with a wide range of qualified equipment that accommodates a variety of methods and scales of primary recovery, inclusion body preparation, solubilization with refolding, chromatography and filtration required to support production up to 200 L scale.
We work to stringent quality control and the highest levels of international regulatory compliance.