IDT Biologika GmbH

  • IDT Biologika - Contract Development and Manufacturing
  • Clinical Trial Materials and Commercial Batches
  • Viral Vaccines
  • Gene & Immune Therapeutics
  • Oncolytic Viruses
  • Protein-based Vaccines incl. VLP's
About IDT Biologika GmbH

IDT Biologika is a global biopharmaceutical contract development and manufacturing organization that specializes in the production of innovative live viral vaccines, viral vectors for gene & immune therapeutics, oncolytic viruses, virus-like particles as well as fill/finish of other sterile liquid and lyophilized biologics to improve human health worldwide. We offer clients in B2B business a single source CDMO partner at our sites in Germany and the USA, with seamless end-to-end solutions and the ability to nimbly scale projects from development through to commercialization. This includes process development, drug substance manufacturing,Fill/Finish, secondary packaging, quality control/analytics and storage. IDT Biologika handles every step in manufacturing and packaging of small clinical batches as well as of products in a large-scale commercial scale. On request of our clients we supply their products in vials, pre-filled syringes (with and without safety devices), autoinjectors or as combination products. In Rockville, MA, USA we utilize broad capabilities and a depth of technologies for process development and manufacturing of clinical trial material for phases I-II. At its headquarters in Europe, IDT Biologika operates one of Europe’s premiere integrated facilities for end-to-end services from process development through clinical phases I-III to commercial manufacturing. Our fully integrated services are underscored by our commitment to quality and operational excellence that flows through our best-in-class process and cGMP (up to BSL2) manufacturing capabilities meeting EMA  and FDA standards (ANVISA ready).  Many human vaccines developed by IDT Biologika, together with international partners, are already in use, fighting infectious diseases such as  COVID-19 Tuberculosis, AIDS, Malaria, Cancer, Dengue and Ebola.

Certifications
  • DE
  • 2015
    On CPHI since
  • 3
    Certificates
  • 1000 - 4999
    Employees
Company types
Contract Service
Primary activities
API Producer
Biopharmaceutical
Contract Manufacturer
Custom Manufacturing/Custom Synthesis
Packaging & drug delivery
Contact info
Meet us at

CPHI Milan 2024

Fiera Milano, Italy
08 Oct 2024 - 10 Oct 2024

Products from IDT Biologika GmbH (5)

  • IDT Biologika as a Contract Development and Manufacturing Organization

    Product IDT Biologika as a Contract Development and Manufacturing Organization

    IDT Biologika is an international leader in the contract development and manufacturing of biologics. The company focuses on the customized development and manufacturing of viral vaccines (phases I, II, III), gene therapeutics, immunotherapeutics, oncolytic viruses as well as sterile liquid and lyophiliz...
  • Process Development for Production of  Viral Vaccines and Vectors

    Product Process Development for Production of Viral Vaccines and Vectors

    Process Development for API Production, Fill/Finish and Secondary Packaging- Cell line development
    - Transfer of customer technologies
    -Upstream / Downstream -iCellis Fermenter: development of scalable upstream and downstream technologies for adherent cells with higher yield.Major ...
  • Drug Substance Manufacturing for Viral Vaccines, Gene & Immune Therapeutics, Oncolytic Viruses and Viral Vectors

    Product Drug Substance Manufacturing for Viral Vaccines, Gene & Immune Therapeutics, Oncolytic Viruses and Viral Vectors

    Drug Substance Manufacturing  for pre-clinical, clinical and commercial supply- Validation of aseptic processes
    - Cell and virus banking 
    - Using own seed cell banks: VERO and DF-1, Duck cell line (AGE-1)
    - API production using different TechnologiesMVA Know-How

    IDT Biolo...
  • Sterile Dosage Filling and Lyophilization

    Product Sterile Dosage Filling and Lyophilization

    IDT Biologika GmbH provides a wide range of pharmaceutical services which includes sterile dosage filling in vials and pre-filled syringes. With a facility size of 3,600m2, this integrated pharmaceutical/ biological site houses more than 7 filling lines for the aseptic filling of syringes, vials, ampoules ...
  • Packaging, Quality Control, Storage, Cold Chain

    Product Packaging, Quality Control, Storage, Cold Chain

    Within the contract development and manufacturing, IDT Biologika GmbH provides a wide range of other pharmaceutical services for our clients products, which include-  Labeling & Packaging of vials, prefilled syringes, autoinjectors
    - Serializiation (Track & Trace)
    - Quality Systems
    - ...

IDT Biologika GmbH Resources (5)