IDT Biologika as a Contract Development and Manufacturing Organization

IDT Biologika as a Contract Development and Manufacturing Organization
Product Description

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 as well as sterile liquid and lyophilized biologics to improve human health worldwide. We offer clients seamless end-to-end solutions and the ability to nimbly scale projects from development and pre-clinical through large scale production and packaging. 
Our fully integrated services are underscored by our commitment to quality and operational excellence that flows through our best-in-class process and cGMP (and up to BLS2) manufacturing capabilities meeting EMA, FDA and ANVISA standards.
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IDT Biologika GmbH

  • DE
  • 2015
    On CPhI since
  • 3
    Certificates
  • 1000 - 4999
    Employees
Contract Service
Specifications
  • Supplied from
    Germany; United States

IDT Biologika GmbH

  • DE
  • 2015
    On CPhI since
  • 3
    Certificates
  • 1000 - 4999
    Employees
Contract Service

More Products from IDT Biologika GmbH

  • 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 advantage for development of safe live viral vaccines using non-tumorigenic cell lines
    - Formulation Development
    - Stability Evaluation
    - Process Development for API production- Development and qualification of own seed cell banks for vaccine manufacturing, GMP cell lines Vero and DF-1, Duck cell line (AGE-1)
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  • API Production for Viral Vaccines and Viral Vectors

    Product API Production for Viral Vaccines and Viral Vectors

    API production 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 Biologika is considered the global leader in MVA (Modified Vaccinia Ankara) and recombinant and non-recombinant poxvirus technologies and aseptic processing

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  • 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 and injection/infusion bottles including lyophilization. This facility has the capability to handle both small-scale and large-scale production - with the flexibility to scale-up as demand grows. Bulk solutions can be prepared in mobile vessels up to 500L. Stationary vessels are used for larger bulk volumes up to 4,000L. The facility runs state-of-the-art cGMP and has been the subject of numerous regulatory audits. Contact us for more information.
  • 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
    - Cold Chain up to - 80°- Storage
    Contact us for more information.

IDT Biologika GmbH resources

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