Contract manufacturing of IDT Biologika
About IDT Biologika

From development through clinical phase I-III to full commercial production of vaccines in vials and pre-filled syringes

IDT Biologika specializes in the contract development and manufacturing of vaccines, gene therapy medicinal products, sterile liquids and lyophilized biologics. We provide GMP compliant end-to-end services in BSL2 facilites meeting FDA standards. Our process development and cGMP clinical manufacturing capabilities and our experience with multiple technology platforms provide a comprehensive foundation for developing processes for live and attenuated vaccine candidates emerging from the research lab for advancing through clinical development to commercial production.

IDT Biologika offers vaccine manufacturing from bulk drug substance to sterile filling through quality control and efficient packaging. The competencies and capabilities reach from early development delivering test samples in small volumes to largescale industrial vaccine production.

Many human vaccines developed by IDT Biologika, together with international partners, are already in use, fighting infectious diseases like tuberculosis, AIDS, malaria,cancer, dengue and Ebola.

End to End Production

IDT Biologika specializes on the development and manufacture of sterile liquid drug products is one of the few companies worldwide, providing fully integrated industrialization services ranging from formulation process optimization and clinical manufacturing to large-scale production, packaging and quality control. The company has experience in technically sophisticated projects such as innovative biopharmaceuticals and lyophilized compounds manufactured in EMA and FDA-inspected facilities.

Development

  • Analytical Method Development
  • Formulation Development
  • Process Development
  • Clinical Trial Manufacturing
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DS Manufacturing

  • Live & Inactivated Bacterial & Viral Vaccines
  • Roller Bottles & Wave Bioreactors
  • iCELLis
  • CEF-Cells
  • Master Seed Virus

Fill & Finish

  • Live Vaccines
  • Inactivated Vaccines
  • Therapeutics Proteins
  • Monoclonal Antibodies
  • Lyophilisation

Labeling & Packaging

  • Secondary Packaging
  • Kit Assembly/Packaging
  • Testsets for Visual Inspection
  • Autoinjectors
  • Safety Devices

Storage

  • Controlled Substances
  • Cold Chain up to -80°C
  • Stability Storage
  • Controlled Freezing & Thawing
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Vaccine Manufacturing more info

Pharmaceutical Development and Manufacturing more info

Advanced Quality Control more info

News

About IDT Biologika