Our Approach
Cornerstones of a successful biosimilar development
Valerius is pursuing to become one of the leading companies in the world for specialty biosimilars
At Valerius, we are building our approach to successful biosimilar development on the harmonization and integration of the following key factors:
Excellent scientific knowledge
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.
Compelling quality concept
It is our highest goal to develop safe medicines that serve patients´ needs. Therefore, our biosimilars are manufactured following our holistic quality management system. To confirm central quality elements such as biosimilarity and interchangeability, our biosimilar candidates and their references undergo a massive characterization program using a vast number of sophisticated analytical techniques. Prior release, the safety and suitability of our products are strictly controlled in full compliance with highest regulatory requirements.
Unique product pipeline
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.
Safe and flexible manufacturing approach
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.
Profound understanding of clinical and regulatory requirements
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.
Strategic alliances with best-in-class partners
Valerius` 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.
Scientific advisory board
Leading experts from biopharmaceutical and biosimilar industry support our development programs by contributing their experience and expertise from various perspectives, such as manufacturing, quality, clinical, and regulatory.