North America

IDT Biologika is a global biologics CDMO offering development and manufacture of Vaccines and Viral Vectors, and aseptic liquid filling and lyophilization of sterile injectables.

Our U.S. facility in Rockville, Maryland is close to Washington D.C., the US National Institute of Health, and is located in a hub for biologics manufacturing.

Legacy in Biologics Contract Manufacturing

Our US site has a long history in the production of biologics. Today, our R&D Center in Maryland specializes in the development of processes and analytical methods for vaccines and gene & immune therapeutics. North American customers find their first point of contact here.

Following successful process development of our customers’ products, these can be transferred to clinical and commercial production. A close collaboration between Rockville and Germany allows access to IDT global network capabilities for IDT Rockville customers.

Process & Analytical Development

 

We have a Process Development Team in Rockville comprising scientists and engineers highly experienced in complex upstream and downstream processes and formulation. We help our customers overcome challenges with their products by defining the appropriate technologies and employing our experience to refine a process that works and can be scaled.

Our Quality Control and Analytical Development Teams support a wide array of analytical technologies needed to develop novel assays for the characterization, release, and stability testing of early-phase vaccines, gene therapy vectors, and protein therapeutics.


Upstream Process
  • Stationary Systems and small scale stirring/shaking systems
  • Stirred Tank Bioreactor Platform (Eppendorf and Sartorius)
  • Rocking Motion Bioreactor Platform (Sartorius)
  • Fixed-Bed Bioreactor (iCellis® Nano, Univercells scale-XTM hydro)
  • Mini Bioreactor System (DASbox®)

Downstream Process

Formulation Development

Process Analytics

Technology Portfolio

Cell Lines

  • MDCK
  • Sf9
  • MRC-5
  • proprietary HEK-293 cell line derivatives
  • CHO
  • proprietary DF-1 (avian)

Viral Vectors

  • Adenoviruses (various species)
  • Baculovirus
  • CMV
  • Poxviruses (various species)
  • Virus Like Particles (VLPs)
  • Adeno-associated viruses
  • MeV
  • RSV
  • rVSV
  • HSV
  • Influenza Viruses

Analytical Capabilities


Microbiology
  • Bioburden
  • Sterility
  • Mycoplasma/Mycobacteria
  • Endotoxin
  • Environmental
  • Antibiotic sensitivity/Resistance (Germany)

Chemical/Physical

Molecular Biology

Virology/Biochemistry