Bioreactors,
Dec 7, Cambridge, MA
IDT Biologika is a leading biologics CDMO providing development and manufacturing of Vaccines, Viral Vectors for Cell & Gene Therapeutics, Oncolytic Viruses, Virus-Like Particles, and aseptic fill-finish for other Biologics, with end-to-end capabilities serving companies worldwide.
Strategic Locations
Rockville, Maryland, USA
Our North American CDMO site is a GMP-compliant facility (BSL-2) with a long history of contract manufacturing of clinical trial materials. It shares many of the state-of-the-art technologies used at our German facility that has both clinical and commercial capacity.
- Process Development
- Clinical-Scale Drug Substance (e.g. Vaccines, Cell and Gene Therapeutics)
- Aseptic Liquid Filling & Lyophilization (Biologics)
- Packaging & Storage
- Analytical Services
IDT Biologika at a Glance
IDT Biologika works with a range of cell lines qualified to current regulations, including proprietary cell lines that can eliminate the need for characterization and other non-proprietary cell lines commonly used in viral manufacturing.
IDT Biologika leverages experience with hundreds of vaccines to find the best way to develop a client’s process. We work with virtually every relevant upstream and downstream technology, so we can recommend the optimal one.
IDT Biologika offers comprehensive analytical development services, including fast-track analytical methods to deliver a competitive advantage to customers from process development through scale-up to commercial manufacturing.
IDT Biologika is one of the world’s most experienced vaccine CDMOs, and a manufacturer capable of assisting with the global underserved need for viral vectors. Our GMP and BSL-2 facilities in Europe and North America meet client needs for drug substance from early clinical to commercial scale.
There are virtually no upstream or downstream methods used today that we do not offer. Every process is different, so when process technology is not yet defined by our client, we will evaluate the parameters and define which of several leading technologies we offer will be optimal based on past experience and knowledge.
We provide aseptic liquid filling and lyophilization in vials and pre-filled syringes as an integrated complement to our vaccine drug substance contract manufacturing and as an independent service for all biologic pharmaceuticals. We offer fill-finish in Europe and the USA and at clinical and commercial scale.
As a biologics contract manufacturing company offering aseptic filling and lyophilization in vials and pre-filled syringes, we also offer secondary packaging and cold chain storage services to meet the needs of companies with clinical manufacturing requirements and commercial products.
Close cooperation of quality experts with manufacturing and engineering activities is key to a reliable supply of high-quality vaccines and pharmaceuticals. This makes internal communication and exchanges with clients very fast and to-the-point.
IDT Biologika has an exceptionally strong regulatory track record. Our facilities have been subject to hundreds of audits from clients and agencies, and we have longstanding expertise in guiding customers through regulatory requirements.
Media & Events
December 7, 2023
2 PM CET, Location: MassBioHub, 700 Technology Sq., Cambridge, MA 02139
Careers
If you want to further your career with a global leader in vaccines, cell and gene therapeutics, and other biologics CDMO services, visit IDT Biologika’s careers section for opportunities in Europe and North America.
Contact IDT Biologika
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