In our R&D laboratory, scientists and engineers collaborate for the development of high performance cell lines and high-end processes, which need to be precisely adjusted for each biosimilar, to deliver considerable yields of the therapeutic protein with desired structure and function.

It is our highest goal to deliver medicines that are safe and serve patients´ needs. Therefore, our biosimilars are developed following our internal holistic quality management system. Prior release, the safety and suitability of our products is strictly controlled in full compliance with highest regulatory requirements. To confirm central quality elements such as biosimilarity and interchangeablility, our biosimilar candidates and their references undergo a massive characterization program using a vast number of sophisticated analytical techniques.

Our exclusive orphan and non-orphan biosimilar portfolio is selected based on evaluation of the medical need for affordable therapies, thorough market analyses, patent research and evaluation of the technical and clinical development demand. Where possible, we aim at improvement, e.g. by developing new formulations to enhance protein stability, or by investigating novel and patient-friendly medical devices. Thereby, we are creating proprietary intellectual property, while generating additional benefits for patients.

We utilize single-use manufacturing technologies to minimize risk of cross-contamination in multi-product facilities, and to enable rapid capacity adjustments. Moreover, the use of disposables allows for a fast and flexible process installation and thus for a local production in developed as well as emerging markets.

With a proven track-record of biosimilar development, our clinical and regulatory expert teams provide strong leadership for the late stage development of our products.

Valerius Bio´s development programs are further strengthened by leading contract manufacturing and analytical research organizations. Our partners provide the cGMP compliant manufacturing of clinical and commercial supplies. They contribute to our extensive protein characterization approach with a battery of cutting-edge analytical methods and provide support in formulation and medical device development.