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Diosynth Biotechnology, is a global Contract Manufacturing Organization (CMO) specializing in current Good Manufacturing Practices (cGMP) Biopharmaceutical production. In our role as a CMO, we have produced recombinant proteins for both clinical and commercial projects and provided a critical role as a strategic Chemistry and Manufacturing Controls (CMC) partner for many developers of biological therapeutics.
Our mission is to be the preferred and most trusted CMO in the biotech industry due to our technical excellence, reliable execution and our collaborative approach in our partnership with our customers.
Service to the Biotechnology Industry:
- 10 plus years in the CMO business
- Completed over 75 projects
Our customers rely on our:
- Experience manufacturing clinical and commercial products
- On-time delivery
- Scientific know-how
Our goal is and has always been to help our customers succeed in what matters most…ultimately delivering the drug to the patient. Through our support in CMC development, biotechnology companies have been assured of dedicated manufacturing services that meets industry requirements in speed, quality and yield.
Diosynth Biotechnology delivers. Our team has solved difficult development problems and overcome production challenges for our customers through the application of great science. We have provided manufacturing solutions for:
- •Proteins developed in Mammalian cell culture systems
- •E. coli and Pichia fermentation processes
- •Baculovirus-based insect cell culture technology
…And we have done so for multiple classes of molecules including:
- •Monoclonal Antibodies (MAbs)
- •Recombinant enzymes
- •Hormones
- •Fusion-proteins
From process to product
These services include:
- •Analytical method development, qualification, and validation
- •Analytical testing
- •Quality systems
- •Technology transfer
- •Fill and finish
Putting quality first
Our commitment to quality covers all aspects of our business practices. We operate under a Quality Management System that assures that all active pharmaceutical ingredients (APIs) produced meet industry standards and all applicable regulatory requirements of the United States, European Union and Japan. Our facilities have been inspected by the US Food and Drug Administration (FDA) and by the European Agency for Evaluation of Medicinal Products (EMEA).
Diosynth Biotechnology is a world leader in process development and cGMP production of recombinant protein biopharmaceuticals. We maintain global biomanufacturing facilities in Research Triangle Park (RTP), NC and in Oss, Netherlands.
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