Small Scale Biotech CDMO Services
Reliable and customized solutions, boosting flexibility and speed in biotech CDMO, from R&D to production of APIs and sterile liquid finished forms.
Small-scale batches expertise
Since 2002, we have gained extensive experience in R&D services and in small-scale GMP manufacturing of APIs and sterile liquid finished forms, supporting our client partners throughout the early clinical development pathway.
Our proven expertise ensures agile and reliable collaboration, enabling seamless project progression from research to clinical production.
Customized solutions
Our customer-focused mindset enables us to provide tailor-made biotech CDMO services, covering every stage from R&D to production and fully aligned with the specific needs of our client partners.
We embrace an open and innovation-oriented approach, ensuring compliance with rigorous quality standards and the scientific excellence of our highly skilled team.
Timely cost-effectiveness
We are committed to delivering timely and effective solutions without compromising quality.
Through a lean and efficient approach, we streamline our processes to increase productivity, improve quality, and reduce costs — delivering maximum value to our client partners.
Wide range of analytical capabilities
We offer comprehensive in-house analytical services to support R&D and GMP productions, including recombinant proteins, monoclonal antibodies, enzymes, and antibody fragments.
Building on our deep technical know-how, we further support our client partners in analytical methods development and validation.
Research & Development
MAMMALIAN & MICROBIAL R&D DEVELOPMENT AND PRODUCTION
Diatheva offers comprehensive R&D services for the development and production of biologics, including recombinant proteins, monoclonal antibodies, enzymes, and antibody fragments.
As part of our integrated R&D offering, we support our partners from early discovery to process optimization, with a focus on quality, scalability, and future GMP compliance.
Our expertise covers mammalian and microbial systems, with optimized bacterial fermentation (E. coli) and mammalian cell cultures, primarily CHO (Chinese Hamster Ovary) cells.
GMP small scale manufacturing
GMP SMALL-SCALE MANUFACTURING OF CLINICAL-GRADE APIs AND STERILE LIQUID FINISHED FORMS
Diatheva provides GMP-compliant manufacturing services for clinical-grade biologics (Phase I and II) produced through bacterial fermentation, focusing on recombinant proteins, enzymes, and other biologically active molecules.
Our platform supports the seamless transition from R&D to clinical supply, ensuring full compliance with international GMP standards.
We provide efficient and flexible manufacturing solutions designed to accelerate time-to-clinic, ensuring reliability and full regulatory compliance.
Sterile Fill & Finish
EARLY CLINICAL PHASE
Diatheva provides aseptic Fill & Finish services for liquid drug products intended for clinical trials.
Operating under GMP conditions, we offer fully integrated and flexible services including formulation, sterile filtration, vial filling, capping, inspection, and labeling.
From early-stage studies to complex clinical designs, our team ensures sterility, precision, and full regulatory compliance throughout the process.
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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