Small Scale Biotech CDMO Services
Reliable and customized end-to-end solutions, from R&D to the production of biomolecules, the release of APIs and finished products for clinical trial
Specialisation and reliability
We are a partner with extensive experience in the biotechnology sector, particularly in the production of APIs and biopharmaceutical finished products for every stage from preclinical to clinical trials. Our scientific expertise, combined with a highly skilled team focused on every aspect of quality and compliance, ensures clients a seamless collaboration.
Customization and adaptability
The ability to provide customized solutions tailored to the specific needs of our clients, always meeting project timelines, is one of the distinctive aspects of our work. We work closely with clients, understanding their specific requirements while maintaining an open and innovation-oriented approach.
Timeliness and responsiveness
Our quick response to emerging needs and our ability to meet deadlines are other distinctive aspects of our approach. We are accustomed to delivering effective solutions promptly, without compromising the quality of our services.
Research & Development
MAMMALIAN & MICROBIAL R&D DEVELOPMENT AND PRODUCTION
Diatheva offer comprehensive R&D services for the development and production of biologics (recombinant proteins, monoclonal antibodies, enzymes, and antibody fragments) through the optimization of both bacterial cell lines fermentation (e.g., Escherichia coli) and mammalian cell cultures, primarily CHO (Chinese Hamster Ovary) cells.
Microbial GMP Clinical Manufacturing
GMP MANUFACTURING OF
CLINICAL-GRADE BIOLOGICS (APIs)
Provinding GMP-compliant manufacturing services for clinical-grade biologics produced through bacterial fermentation, with a focus on recombinant proteins, enzymes, and other biologically active molecules.
Sterile Fill & Finish
STERILE FILL & FINISH
Diatheva provide aseptic fill and finish services for liquid drug products intended for clinical trials. Services include formulation, sterile filtration, filling into vials, capping, visual inspection and labeling – all in compliance with GMP regulatory requirements.
Testimonials
The preparation of microorganism Cell Banks in compliance with GMP is not an activity that laboratories or biotech companies offering contract services are generally able to guarantee. From the very first contact, Diatheva’s team made themselves available to fully understand our needs and to resolve the inevitable challenges that arise during project development. Throughout the preparation and execution phases, there was a continuous exchange of information and documentation review. Our experience with Diatheva has been decidedly positive, and we plan to rely on their services again in the future—not only for Cell Bank preparation, but also for the development of new biotechnological processes.
We worked with Diatheva to produce a GMP recombinant enzyme for a cell-based enzyme replacement therapy that we were developing. Diatheva were a pleasure to work with; they were effective in achieving the targets set by our milestone driven project and were responsive to our needs. Their knowledge of the regulatory landscape was outstanding, this contributing to us obtaining approval from the Medicines and Healthcare products Regulatory Agency for a Phase II study.
Qualified staff, always open to discussion on highly complex topics such as the development of a biological product for research purposes. The company also managed supplier relationships exceptionally well during a critical time like the pandemic.
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