The IDT Difference
Due to new treatment methods, the demand for vaccines, gene & immune therapeutics and sterile injectables will continue to increase in the coming years – and with it the demand for partners with the corresponding skills and production capacities. These partners must be able to handle live viruses and have the necessary infrastructure to ensure all relevant biosafety levels. IDT Biologika plays a leading role in this special field thanks to its many years of experience.
Services
Experience with Live Agents and Proteins
Thanks to state-of-the-art facilities, our customers can rely on consistently high quality manufacturing – from process development and clinical manufacturing to commercial BSL-2 production. We have proven over many years that we can meet the complex requirements of innovative vaccine and biopharmaceutical companies, including the production of leading vaccines. With our experience, flexibility and equipment, we can offer most platform technologies. Our track record in numbers:
Fighting Infectious Diseases Worldwide
Occurence of infectious diseases and involvement of IDT Biologika (in Green).
For governmental businesses IDT Biologika has been providing emergency use vaccines for more than 15 years and we are also part of the German Government’s pandemic preparedness.
Dedicated, Cross-Trained Team
Our interdisciplinary team has mastered the manufacturing processes for vaccines as well as gene and immune therapeutics. Working with customers to realize difficult and complex projects is part of our daily business. This enables smooth transitions from the early development phase through clinical trials to commercial production. We train the teams for process development and GMP production on a cross-divisional basis, thus enabling extensive integration of workflows when scaling up processes. The employees in the development department are highly committed to ensuring a seamless transition to GMP production. Furthermore, they have extensive expertise in the wide range of technologies we offer.
End-to-End service that covers the entire value chain
At IDT Biologika, we recognize how critical vaccines and novel therapeutics are to protecting and improving quality of life for patients around the world. We are a full service provider and 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.
From contract development, through clinical Phases I-III, to commercial production of vaccines and gene and immune therapeutics.
Process and Analytical Development
Services and Capabilities
• Tech transfer
• Up- and downstream development
• Formulation development
• Process characterization
• Process optimization
• Development of analytical methods
Technologies
• Fixed bed & stirred bioreactors
• Automated filling capacities
• Assay pre-validation
• Particle characterization
• Spectrometric tools
• Nanophotometer
Drug Substance Manufacturing
Services and Capabilities
• BSL 1, 2
• Viral and mammalian seed
materials (MCB/WCB, MVB/WVB)
• Clinical trial material (phases I–III)
• Commercial manufacturing
• Process validation
• Analytical validation
Technologies
• Fixed bed & stirred bioreactors
• Cell factories, roller bottles
• Aseptic manufacturing of DS
• Tangential flow filtration and chromatography
Aseptic Fill-Finish
Services and Capabilities
• BSL 1, 2
• Bulk formulation
• Aseptic filling (vials, syringes)
• Lyophilization
• Clinical trial material (phases I–III)
• Commercial manufacturing
• Process validation
Technologies
• Automated large scale and pilot scale filling of vials and pre-filled syringes
• Large-scale lyophilizers (178,000 vials max capacity)
• Automated, semi-automated and manual visual inspection
Labeling and Packaging
Services and Capabilities
• Technology development
• Labeling, blistering, packaging
• Safety device assembly
• Combination products
• Serialization (track and trace)
• Code reading systems
Technologies
• Track & trace, serialization, tamper evidence and aggregation
• Level-5 interfaces
• SAP Pharma Network & Tracelink
• Manufacturing execution system (MES)
• Advanced cold storage logistics (chambers, pallets storage down to -65 °C)
Quality Control and Analytics
Services and Capabilities
• Method transfer and development
• Implementation and validation
• Raw material testing and release
• In-process testing
• Batch release testing
• Stability studies
• Environmental monitoring
• Utility monitoring
• Cleaning validation analytics
Technologies
• Fast track analytical methods (e.g. Adventitious Agents Testing via NGS, Fluorescent Activated Cell Sorter, Mycoplasma Testing by qPCR)
• Full range of Pharmacopeia assays established
• Labor information management system (LIMS)
Innovation
IDT Biologika is committed to innovation that makes a positive difference for clients and ultimately for patients by combating serious diseases affecting people worldwide. Our experience and successes with live viruses and their use in vaccines and gene and immune therapy, along with broader biotherapeutics, enable us to pursue innovation that has an impact where it counts – in our customer’s process. There is little that we haven’t seen or experienced, which is beneficial to our customers, but equally nothing drives us like a new challenge, and we think our unique know-how in live virus products sets us apart in this industry.
Innovation is also about collaboration. The most innovative results come from like-minded and shared knowledge. For this reason, we are committed to transparent relationships with our customers where we work towards solutions together. We will give every bit of our more than 100 years of experience, but we are also committed to listening to what our customer thinks and adapting our approach.
The final goal of innovation is to improve our customer’s process. Whether we begin a relationship in the early stages of development or transfer a process, there is always potential for our process development team and other experts in multiple technologies to look at where optimization is feasible and would be transformative for our client. Advanced analytical services also support the process, and we can meet early-stage clients’ needs with proprietary cell lines and cell bank services.
IDT Biologika Investment Timeline
Installation of assembly lines for safety devices and auto-injectors
Expansion of visual inspection capacity. Installation of large-scale filling line.
Expansion of storage capacity for -80ºC and stability and retention samples. GMP upgrade of pharma production facility. Installation of pilot filling line and Schubert Multipacker packaging line.
Expansion of large-scale filling capacity with a new state-of-the-art filling line.
Expansion of drug substance manufacturing capacity with new dedicated building.
Expansion of large-scale filling capacity with a new state-of-the-art filling line. Additional capacity in drug substance production and visual inspection.
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