Boehringer Ingelheim material to TeGenero was legally compliant

Boehringer Ingelheim, the pharmaceutical group, has announced that material supplied to TeGenero for use in preclinical and clinical development complied with all regulations.

The two companies had entered into an agreement in 2003 for the production of GMP-material of the TeGenero compound CD28-SuperMAB, a monoclonal antibody.

Following the disastrous trial last week that involved the admittance into intensive care of six volunteers involved in a TeGenero clinical test, Boehringer Ingelheim had documentation and the release procedure for the material it supplied reviewed.

It was subsequently found to comply with all pharmaceutical and legal requirements. The material had been made to TeGenero’s specification and following acceptance from regulatory authorities in the UK and Germany, Boehringer Ingelheim supplied the material “for investigational use only”.

Prosecutors in Germany are currently weighing up whether to take action against TeGenero following the catastrophic phase I trial of the TGN1412, or Parexel, drug.

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