In our manufacturing site the most advanced technologies for production of biotechnology (recombinant) proteins from Prokaryotic and Eukaryotic cells are available. We have the capability to produce a wide range of biosimilar API.
Manufacturing processes are carried out in an area of 1000 square meters in two independent and segregated production lines, dedicated to the manufacturing of therapeutic proteins from mammalian and bacterial cells, respectively. Our active pharmaceutical ingredients are manufactured in a form ready for formulation and filling.
In the Helvetic BioPharma manufacturing plants, we guarantee that all our products are obtained with the highest level of quality, in full compliance with the cGMP requirements. We also apply the highest standards of respect of the environment and the personnel safety.
- QUALITY CONTROL
The Quality Control Department carries out a wide range of analysis and approval testing, at the different levels of the manufacturing processes, in accordance to GMP, GLP and ICH guidelines. In an area of about 300 square meters the laboratories are equipped with the most advanced instrumentation and can apply the most sophisticated analytical techniques. The high level of professionality of our experienced personnel guarantees that the strict analytical requirements of the Biotechnology/Pharmaceutical industry are always and totally fulfilled.
The laboratories have full analytical capabilities, such as microbiology tests and cell analysis, physico-chemical and bioanalytical methods application.
- QUALITY ASSURANCE AND REGULATORY AFFAIRS
The highest level of quality for our products is consistently ensured by a strict application of the international requirements of the Biotech/Pharma industry. The Quality Assurance Department guarantees a constant and continuous alignment of the activities and processes to the quality requests and the guidelines.
The Regulatory Affairs Department provides the needed expertise for the registration and post-approval surveillance of our products in many countries all over the world. Professionality and the long experience of our personnel, as well as the deep knowledge of the international regulations are the basis of our successful strategy to the registration of our drugs.