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Biopharamceutical analytical service

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Analytical Services

 
laborComplete range of extensive biopharmaceutical services

IDT Biologika has one of the most advanced Quality Control infrastructures in the business. Our complete range of extensive biopharmaceutical services are based primarily on our own innovative research, development and manufacturing.

 

As a matter of course this assumes a continual development of analytical methods as for example FTIR or Q-PCR and standard analysis technology together with an efficient and secure data management programme. Quality Control encompasses complete testing services ranging from method development, method transfer and method validation right up to the performance of routine testing in the context of the analyses relevant for release. IDT quality control  is expert in the testing of starting materials, packaging, intermediary products and finished drug products.

Product stability tests

In addition product stability tests are performed and tests for other pharmaceutical concerns are carried out on contract.

FDA and EMEA standard 

IDT has been inspected by the FDA and EMEA.The high GMP standard in the quality control is verified through inspections conducted by both national and international authorities and also by customers. The strict requirements ensure the GMP status of all facilities, processes and documentation.

Analytical lab services

Within the quality control of vaccines and pharmaceutical the following fields are well established:

  • chemico-physical analysis
  • microbiological analysis
  • cleanroom monitoring
  • in-vivo test processes
  • virological test methods
  • molecular biological test methods
  • biochemical analysis
  • immunological test methods

To accomplish the tasks quality control is structured in five specialist laboratory areas and a department of sample and electronic data management.

 

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