IDT Biologika uses a wide range of technology platforms to propagate live viruses and our Process Development Team will work in early-stage projects to identify the optimal technology. However, many of our clients already have an idea of their process and how it should work, especially if they have already done development work or even clinical production elsewhere. In these cases, we have considerable experience and proven SOPs to ensure a risk-mitigated transfer.
Drug Substance Manufacturing
IDT Biologika is one of the world’s most experienced CDMOs in terms of expertise in developing and manufacturing of Viral Vaccines, Viral Vectors for Gene and Immune Therapeutics, Oncolytic Viruses, Virus-Like Particles, and other Biologics. We have GMP manufacturing facilities in Europe and the United States, offering capabilities from early-stage development through clinical to commercial scale. In Drug Substance Manufacturing, we provide master / working cell banks, master / working virus seeds, manufacture of bulk drug substance, and multiple manufacturing platforms. Working with our clients, we have been involved in the development and GMP manufacture of many of the world’s most notable vaccines developed over the last two decades.
Preclinical, Clinical and Commercial Supply
Customers come to IDT Biologika at both clinical and commercial stages, and in each case, we look at the process and the needs of the project and tailor our approach and, if still undefined, the technologies we employ to optimize the outcome. If our client is ready to go straight into GMP manufacturing at BSL-2 or BSL-3 with a clinical project, we will move towards that as quickly as possible.
If the process would benefit from further development, our PD and Manufacturing Teams are closely integrated, and we will work on development and scale clients’ processes to commercial volumes. Our Process Development Teams are cross trained in the GMP environment, so personnel are usually very close to the process throughout, making it as seamless as possible.
If a client has their micro-organism but needs development, we work with a range of platform technologies that can be used to optimize the process. We can manufacture a client’s cell bank for them. Our Analytical Teams can test all processes, sequencing viruses. We have a range of assays that are qualified, and we can also develop custom assays if needed. Our Regulatory Department also supports clients throughout the lifecycle of each product.
IDT Biologika is expanding drug substance capacity at our Dessau facility dedicated to GMP production of live virus products to BSL-3 to provide a greater level of volume and flexibility to suit the varied needs of our clients. We also transfer processes between our sites in Europe and North America based on the needs of projects and convenience for clients.