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Close to 20 years’ experience in making drugs and medical instrumentation safe.

The biosafety of drug candidates, or any other xenobiotic or substance used by humans is a crucial question that requires guidelines to be applied and the implementation of standardised experimental tests.

Based on the various infectious diseases that have emerged over the past 30 years (viral infections such as HIV, SARS, influenza virus, Dengue and Chikungunya fever, prion infections, nosocomial infections, etc.), microbiological risk represents a major public health issue: the safety of biological drugs and medical instruments is a crucial factor during their development and use as part of a clinical routine.

Oncodesign provides the benefit of close to 20 years’ experience in making drugs and medical instrumentation safe, in particular with viruses and prions.

  • With drugs, it is crucial to ensure the biosafety of raw materials, implement processes to eliminate agents during manufacturing (HCP) and control intermediate and final products.
  • With medical and surgical devices, attention has to be paid to addressing the specific risk of infection and its load, and offering an effective decontamination or sterilization process compatible with the proper operation of medical devices.

The experimental approaches implemented by Oncodesign (possible in our level 2 or 3 high-security laboratory facilities) aim to challenge the manufacturing process for biologics or the physical and chemical process used to decontaminate medical instruments and to quantify the residual infectious loads. The tests for biologics are performed in a laboratory using miniaturized process mimicking effectively the industrial manufacturing chains.

Contact us today to talk about your project