Case: UniQure

uniQure is a company specialised in gene therapy. They develop gene therapies using an innovative and modular technology platform, including a proprietary, cost-effective production process. They collaborate with healthcare providers to treat patients with genetic disorders.

The challenge of uniQure

In mid-2016, Kalibra was approached by uniQure. uniQure was looking for a partner who could manage, calibrate, and validate its laboratory equipment and clean rooms. In addition, Kalibra was asked to support uniQure with their planned moved.

The specific wishes and requirements uniQure had with regard to these services included:

  • Being able to start quickly on a secondment basis, so that delays could be eliminated
  • The aim was to focus on a long-term relationship or partnership
  • Complete unburdening in the field of management, calibration, and validation of laboratory equipment and clean rooms, including hiring and supervising external companies
  • Expertise and knowledge in the field of pharmacy and GMP, among others
  • Good communication and physical presence at uniQure on location
  • Possibilities for deploying extra capacity and guaranteed replacement in the event of absence and/or illness

 

Why Kalibra?

Based on the wishes and requirements of uniQure, in September 2016 Kalibra started with the deployment of a seconded Kalibra specialist at uniQure. In addition, a contract was drawn up in the run-up to 2017 so that Kalibra could take over full management from 1 January 2017, including hiring and supervising external companies.

After the initial start-up period, Kalibra started managing, calibrating, and validating the laboratory equipment in 2017. In addition, Kalibra supervised the relocation of equipment, took care of the initial validations, and deployed an extra consultant who advised on the renovation. This included drafting protocols and carrying out commissioning activities. The aim was therefore complete unburdening.

In the following years, Kalibra further optimised its services based on periodic evaluations. In addition to the permanent seconded specialist at uniQure, extra capacity is regularly used.

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Result of the Collaboration

The unburdening of uniQure by deploying the right specialists, expertise, and good communication has resulted in a full-fledged partnership between uniQure and Kalibra. This partnership forms the basis for ensuring that Kalibra’s services continue to meet the changing wishes and requirements of uniQure in this dynamic industry in the coming years.