- Rheumatology
- Autoimmune diseases (skin and gut affected)
- Osteoporosis
Preclinical Capabilities
Gedeon Richter Biotechnology Business unit has vertically integrated in-house CMC development
capabilities. Mammalian biologics development capabilities are located in Budapest Hungary, while
microbial development capabilities are located in Hamburg Germany (Richter BioLogics). The Biotechnology
R&D organization (Biotechnology Process Development and Analytics, BPDA) covers from early
development clone selection, early analytical methods, through upstream development, downstream
purification, to formulation/drug product development and drug-device combination product development.
Equipped with state of the art instrumentation, all biologics specification and characterisation
attribute methods can be developed and measured in-house like: Bioassay methods (potency and effector
functions both binding and cell based assays), Physichochemical methods, Biophysichal methods (higher
order structure and subvisible particle methods), Structural characterisation (MS and NMR) and Process
related impurities covered. Process development is supported with high throughput platforms and
extensive statistical and PAT tools are employed at each stage of the development process. Drug product
formulation development can cover both normal and high concentration biologics and liquid and
lyophilised forms as well. Regarding DDC, prefilled syringes (incl. NSD), autoinjector and pen
development are included besides vial format. RG BBU have experience in development and registration of
biologics for all developed markets like US, EU, JP, KR. The existing platforms can support both
biosimilar and innovative medicines CMC development.
The developed processes can be scaled up to internal manufacturing facilities (FDA and EMA approved DS
and DP facility in Debrecen Hungary, and Microbial Facility in Bovenau Germany). Having a structured and
well-established technology transfer and process control/validation strategy, the processes can be
implemented efficiently supported by the local MSAT teams. R&D and MSAT are experienced in
external technology transfers, too (both as providing and receiving site).
Clinical Capabilities
Our capabilities in clinical development and clinical operations span the full development spectrum of drug development, from early strategic planning through late-phase execution. We bring deep expertise in indication selection, clinical program design, integrating insights from external experts and our Global Medical Affairs colleagues to ensure regulatory and commercial success.Operationally, we manage all phases of clinical research, from first-in-human studies to large global Phase III trials. Our in‑house functions - including clinical supply, data management, biostatistics, and clinical monitoring - provide the infrastructure needed to run programs efficiently and with high quality. This integrated setup enables us to design, execute, and oversee complex clinical programs effectively, whether operating independently or in partnership.
License-out
We are seeking for commercial partners with strong experience in the registration and commercialization of biosimilars, and who are ideally present in the fields of osteoporosis, rheumatology and autoimmune diseases. We need partners primarily for the US market, plus other non-European territories.
License-in
We are looking for:
Primarily late-stage biosimilar assets that would fit our strategic therapeutic fields (osteoporosis, rheumatology and inflammatory autoimmune diseases). We would commercialize such in-licensed products across Europe and selected LATAM countries
Co-development:
- We are seeking for global co-development partners for our early-stage biosimilar assets with companies who have FDA/EMA approved manufacturing facilities, deep expertise in development of biosimilars and ideally a strong US commercial presence.
Within such a collaboration Gedeon Richter could take on development efforts, global manufacturing for selected biosimilar assets and the commercialization of the biosimilar assets across Europe and LATAM countries.
