Biosimilars

BioXpress Therapeutics is committed to develop and manufacture biosimilars cost-effectively without compromising quality and safety.

All our procedures comply with European Medicines Agency’s (EMA) and FDA’s (Food and Drug Administration) biosimilar requirements.

At BioXpress we also care about natural resources. Therefore, we aim at reducing environmental impact of all our biosimilar developments.

To achieve these objectives, we presume technical requirements for our biosimilar drug development:

  1. Cell Line Development; particular emphasis is given to state-of-the-art technologies resulting in high producer cell lines.
  2. Manufacturing of biosimilars; for each biosimilar we aim at developing a process that allows for significant reduction of manufacturing time and costs and a significant increase in product yield. This is achieved by implementing latest technologies like intensified and continuous manufacturing.
  3. Characterization and comparability of biosimilars; at BioXpress each project starts with the full characterization of the originator drug. Combined with our outstanding process development expertise we ensure that each drug we develop is highly similar to the originator. This results ultimately in a complete analytical comparability package ready for clinical trials.

The combination of these three technical requirements will make sure that our biosimilars can be produced cost-efficiently with strongly reduced environmental impact and retaining clinical efficacy and safety just as the originator.

Based in Geneva, Switzerland, the Company was founded by industry leaders biologic drug development, including cell-line development and analytical characterization and has built a team of experts in the production of biopharmaceuticals and biosimilars.