Technology transfer in the biotech space

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  • Case Study
  • July 06, 2023

A leading biotech company with a breakthrough gene-editing technology wanted to transfer their tech to a Contract Development and Manufacturing Organization (CDMO) for clinical trials and to prepare for commercial launch. This is how we handled their request.

From tech transfer to regulatory accreditation

The company called upon us to manage the complete technology transfer from the US to Belgium, from sourcing raw materials to conducting engineering runs. This required developing and fine-tuning the manufacturing process for four different allogeneic CAR-T drug products to supply phase 1 clinical trials, overseeing all aspects from fill & finish to packaging, analytical methods, quality control and release testings.

The objective was to supply hospitals and implement patient enrolment programs in preparation of the product’s commercial launch, going through method and process validations, equipment qualification, material testing, to be ready for accreditation by international regulatory authorities.

technology transfer

A successful commercial roadmap implementation

Within a timeframe of approximately two months from production to shipping, we managed the successful technology transfer, followed by the manufacturing and supply of four allogeneic CAR-T drug products for clinical trials. Thanks to this, we enabled the implementation of the company’s strategy and roadmap for its product’s commercial launch.

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Contact us

Jan Debaere

Jan Debaere

Partner, Health Industries Lead, PwC Belgium

Tel: +32 473 92 46 11

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