It will make targeted investments and integrate cutting edge technology
Leading CDMO Recipharm is expanding its pharmaceutical development capabilities, through targeted investments and the integration of cutting-edge technologies.
This investment bolsters its services for early and late-stage product development, including clinical study supply at small and pilot scales and wide range of commercial technologies.
Following this investment, Recipharm’s fully integrated services will cover the whole life cycle of a molecule from APIs route scouting to commercial manufacturing of pharmaceutical products.
Recipharm’s development centres, strategically located in Europe, the US and India, are equipped with tools and infrastructure to deliver leading solutions.
Guided by the Quality by Design (QbD) principle, Recipharm's experts leverage the innovative ReciPredict platform, which combines material and process sciences, statistical tools, modelling and simulation to drive the development of robust products.
Expanding small molecule development capabilities
Recipharm's centre of excellence for small molecules (NCEs and generics) in Bengaluru, India, is expanding its capabilities with a new lab for sterile product development. This is in addition to the new extractables and leachables, nitrosamines and elemental Impurities laboratories, which have become recipharm flagship location for comprehensive analytical services.
In Zwickau, Germany, Recipharm’s pilot-scale development centre focuses on dry granulation, tableting and hard capsule filling, with expertise in combination products.
In addition, recent investments at both Bengaluru and Zwickau include advanced material characterisation equipment, a compression and compaction simulator, a Mini-Pactor for dry granulation, a pilot-scale capsule filler and a small-scale tablet press.
Enhancing sterile product development
Recipharm has strengthened its pre-clinical, clinical and pilot scale sterile development capabilities for both small and large molecules, including liquid vials, pre-filled syringes, blow-fill-seal and lyophilised products. Significant investments include the establishment of a development lab for sterile formulations for small molecules in Bengaluru, the installation of a GMP VarioSys line for vials and pre-filled syringes at the Wasserburg site and a GMP LAB+ equipment at the Kaysersberg site.
Leading the way in biologics and ATMPs
ReciBioPharm, Recipharm’s biologics and ATMP development segment, operates from sites in Watertown in the US, Cuxhaven in Germany and Lisbon in Portugal. The Group’s capabilities in biologics include monoclonal antibodies and recombinant proteins, while in the ATMP space, it is at the forefront of developing innovative medicines and supporting clinical trials for microbiome, oncolytic viruses, nucleic acid (xRNA/LNP), viral vectors (AAV, Lentivirus) and bacterial vaccines and therapeutics.
API capabilities
Recipharm’s site in Yavne, Israel, continues to offer integrated services from route scouting for new chemical entities up to small scale API for tox studies, first in man studies and early clinical supplies. In addition, related impurity management and analytics are part of the integrated offering.
Commitment to global standards and regulatory excellence
All Recipharm development centres are equipped to support clinical trials across the US, EU and other relevant regions, adhering to the highest regulatory standards. With fully integrated analytical capabilities, Recipharm continues to support the development of new medicines with a commitment to quality and innovation.
