The IDT Difference
The steady growth in biologics in the last few decades is set to continue, and new modalities will take the need for expertise and capacity further. Within biologics, experience with live viruses and the capability and infrastructure to manufacture to relevant biosafety levels is a challenging niche, and IDT Biologika is a CDMO with significant experience and is thus a leader in this area.
Experience with Live Agents and Proteins
Our state-of-the-art facilities serve as a critical translational bridge from process development through clinical to commercial BSL-2 manufacturing. We have shown over many years that we can address significant challenges and meet the program needs of vaccine and biopharmaceutical companies. This is highlighted by our track record over the last two decades that includes involvement with many of the leading vaccines successfully developed to combat disease. We also have the experience, flexibility, and equipment to support most platform technologies.
Dedicated, Cross-Trained Team
Our team has exceptional depth and breadth of experience in third-party viral and biologics manufacturing procedures. We work with our customers to handle difficult and complex projects, enabling the transition from early concept through clinical trials to commercial manufacture. IDT Biologika cross-trains process development and GMP manufacturing teams so that there is a strong integration of knowledge and success in scaling up processes. Development staff will work to ensure that there is a seamless transition into GMP manufacturing conditions, and there is an incredible depth of knowledge of the breadth of technologies we offer and what they can do for customers’ processes, across IDT Biologika’s end-to-end operational capabilities.
End -to-end-service that covers the entire value chain
IDT Biologika is a full service provider. We cover the entire value chain from contract development through clinical phases I to III to commercial production of vaccines, gene and immune therapeutics, including quality control, packaging and storage.
Innovative Problem Solving
IDT Biologika intuitively understands the value of technological flexibility and exploring different approaches to solving difficult problems. With years of experience solving a wide range of challenges with live virus processes, and evaluating and using different technologies, we can bring an unparalleled level of innovation to our clients’ projects. Innovation predominantly comes from our people drawing on their great experience and know-how, but the depth and breadth of that knowledge also comes from the diversity of manufacturing platforms and technologies we employ and have had experience using over many years.
Audits and Client Inspections
Transparent collaboration with our clients is a key aspect in ensuring compliance to regulatory filings. Regular inspections prove that our services are underscored by our commitment to quality and operational excellence that flows through our best-in-class process and cGMP manufacturing capabilities meeting FDA, EMA and ANVISA standards.
- 10 to 15 official inspections annually
- 15 to 20 customer audits annually
- 12 US-FDA inspections in Dessau since 2006
- Last FDA inspection in September 2023