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

Legacy in Biologics Contract Manufacturing

The Rockville site has a long history of biologics contract manufacturing and state-of-the-art technologies used to develop and manufacture clinical trial materials for vaccines and cell & gene therapeutics. We provide clinical phase I–II manufacturing at the Rockville site, which is convenient for customers located in North America.

Close collaboration between Rockville and Germany allows access to IDT global network capabilities for IDT Rockville customers.

In 2022-23
Over 15 different customer programs for process and analytical development, cell banking, virus seed banking, clinical (Phase I/ II) drug substance, fill/finish, release testing and stability studies.

IDT Rockville Site Overview

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


Our U.S. facility is a fully integrated BSL-2-compliant manufacturing site, and we have cross-trained, flexible teams, which makes the process of transferring from process development to GMP manufacture seamless.

Our facility offers GMP manufacture, testing, and release of cell and virus banks. We also offer GMP manufacturing of bulk drug substance, final formulation and aseptic liquid filling of fill-finish for Phase I-II clinical trial supply. These services are supported by our analytical testing and quality groups to include release testing, quality release, and stability studies.

Upstream Technologies

Rocking Motion Bioreactors
  • 50L/100L wave bag
  • Cell Culture

  • Virus production

rocking motion bioreactor

Single-Use Bioreactors

Hyper Stack Cell Factories

Fixed-Bed Bioreactor System

Downstream Technologies

  • ÄktaTM process
  • ÄktaTM ready
  • Standard Processing

  • Aseptic Processing (closed system)


Tangential Flow Filtration

Analytical Capabilities

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


Molecular Biology


Filling of Vials for clinical use

Two options available for vial filling:

  • Semi-automated filling up to 2,000 vials (glass or CZ vials)
  • Fully-automated filling up to 2,000 – 8,000 vials (CZ vial capability)
  • Schott vials, West Stopper, West Cap are standard, additional types can be accommodated
  • Over 22,000 vials over 2022-23, with process development /tech transfer for 8 different customer projects requiring GMP fill/finish with 100% success rate

Audit History

  • 15 audits over the last 3 years by:
    • ex U.S. Food and Drug Administration Auditors
    • Qualified Persons (QP)
    • Client Quality Auditors
    • Biologics Consultant Group (BCG)
    • Strategic Compliance International
    • ISO certification agencies (QSR)
  • Facility has been inspected by the Centers for Disease Control (CDC)
  • Quality Management System ISO 9001:2015 certified
  • Facility has a volunteer Site Master File (SMF) on file with the FDA
  • QA Technical Release of GMP Product – QP release in coordination with IDT Biologika GmbH, when needed
End-to-End CDMO Services

Rockville is closely integrated with our facility in Germany, so if needed, we can transfer a process after clinical trial material production to Dessau-Rosslau for Phase III and commercial production.

Strategic Locations

IDT Biologika North America

1405 Research Blvd.
Rockville, MD 20850, USA
Tel: +1 240 599 3000

How to get there