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Strategic Locations

IDT Biologika is a global biologics CDMO offering end-to-end development and manufacture of vaccines and viral vectors for cell and gene therapeutics, and aseptic liquid filling and lyophilization of a range of biologics. In Europe, our main facility at Dessau-Rosslau, Germany is one of the world’s leading integrated vaccines and biologics facilities offering contract manufacturing services meeting GMP and BSL-2 requirements.

Our Facilities

Our facilities are purpose-designed and built to handle live viruses and a wide range of biologics that require containment and special handling. We develop and manufacture live and inactivated vaccines up to BSL-2.

Services at our sites in Germany cover the whole value chain for vaccines and viral vectors from process development through clinical phases I–III to full commercial manufacturing of drug substance and aseptic liquid filling and lyophilization for vaccines and other biologics. These services are supported by integrated packaging and storage, analytical services, quality control, and regulatory support.

We have a second European facility in Magdeburg, Germany, which provides additional process development laboratory capacity that supports Dessau-Rosslau in cell culture technologies, fermentation, virus production and process analytics.

Process Development

Process Transfer, Development, Verification, Qualification and Validation
Formulation and Lyophilization Development
In-Process Testing
(viral, bacterial, protein, DNA)
New Platform Technologies

Vaccines and Viral Vectors

MVA / Vaccinia Virus
Orthopoxvirus
Adenovirus
Adeno Associated Virus
Avipoxvirus
Vesiculovirus
Measles Virus
Lyssavirus
Herpes Simplex Virus
Lentivirus

Drug Substance Manufacturing

Transfer of Customer Technologies
Cell Line Development
Cell & Virus Banking
(MCB/WCB, MSV/WSV)
Upstream/Downstream
Process Validation
Stability Studies

Own Cell Lines

DF-1

HEK-293

VERO

Cell Lines

MRC-5

SF9

CHO

MDCK

Upstream Technologies

Cell Factories
Microcarrier Technology
iCELLIS^® Fixed-Bed Bioreactor
UNIVERCELLS Technologies
Stirred Bioreactors
Roller Bottles

Downstream Technologies

Centrifugation
Depth Filtration
Continuous Flow Centrifugation
Tangential Flow Filtration (TFF)
Chromatography

Aseptic Fill-Finish

Process Transfer
Bulk Formulation
Aseptic Filling
Lyophilization
Visual Inspection (automated, semi-automated and manual)

Visual Inspection

Full-Automatic Visual Inspection

High-performance automated visual inspection unit
Up to 36,000 vials 2R per hour
Especially for large batch sizes and commercial supply

Semi-Automatic Visual Inspection

Vials (lyophilized)
Vials (liquid) possible, but not established

Manual Visual Inspection for all formats

Vials (liquid)
Vials (lyophilized)
Syringes (liquid)
Pens (medical device)
Blisters

In order to keep up with market demands and new therapeutic areas, IDT Biologika has expanded its capacities of eight dedicated aseptic filling lines by another new high-speed line. With batch sizes of up to 500.000 vials, this line is one of the fastest in the world and can serve up to 100 million vials per year. The line can handle both BSL-2 projects and other biologics and contains a fully automated visual inspection, an own air ventilation system, including return air filtration and H2O2 decontamination and inactivation.

Ask us about our Fill-Finish available Capacity

Learn more

Labeling and Packaging

We support integrated or standalone clinical and commercial packaging.

Technology Development
Labeling, Blistering, Packaging of Vials and Pre-filled Syringes
Single and multi-component packages (Kit Packaging)
Safety Device Assembly Labeling, Packaging
Pen / Autoinjector Assembly and Packaging
Combination Products
Serialization (Track and Trace)
Code Reading Systems
Storage between -65 and 25 °C (-85 and 77 F)

Quality Control and Analytics

Method Transfer, Development, Verification, Qualification and Validation
Raw Material Testing and Release
In-Process Testing
Batch Release Testing
Stability Studies
Environmental Monitoring
Utility Monitoring
Cleaning Validation & Analytics

All Quality Control Testing can be done in-house.

Learn more about our Quality Control & Analytics

End-to-End Biologics CDMO Services

Our Dessau-Rosslau site provides fully integrated services for Viral Vaccines, CGT Products and drug product services for other Biologics and Sterile Injectables.