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.
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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