Europe

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

 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.

 

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
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End-to-End Biologics CDMO Services

Our Dessau-Rosslau site provides fully integrated services for vaccines and viral vectors, and drug product services for other biologics.

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Strategic Locations

IDT Biologika USA

1405 Research Blvd.
Rockville, MD 20850, USA
Tel: +1 240 599 3000
Email: info@idt-biologika.com

How to get there