Reinout Hesselink | ATMP Process Architecht
Antleron

Reinout is an effective professional in the field of cell and gene therapies manufacturing, with over 17 years of experience and an emphasis on CMC, product development and quality. As a consultant he has focussed on the development of cell and gene therapies and their production process from early clinical up to commercial products. He has a proven track record as a general manager, CMC and quality manager. He has helped writing and filing of IMPD’s, IND’s (Section 3) and market applications in both the EU and US and has helped to prepare sites for PPQ runs (both viral vector and cell therapy products). 
His technical expertise was very instrumental in the development of PD and CMC strategies, investment decisions, due diligence and quality audits and in supporting technology transfers as well as providing input in the design of manufacturing facilities. 
Reinout has successfully consulted and guided process development, scale up and CMC programmes of clients worldwide, both in cell as well as in gene therapy manufacturing (lentiviral, retroviral and AAV based vectors). Recent example clients are Freeline, Meira, Gensight, Orchard. 
The viral vector processes developed involved a.o. in the scale-up of the up-stream process of gene therapy production (currently to 200L) and defining the down-stream process for purification of AAV’s (different serotypes) and lentiviral vector. He has a thorough knowledge of the regulatory landscape on ATMP’s, both from EMA as well as FDA perspective.