Cell And Gene Contract Manufacturers Must Embrace Digitization

By Rachit Jain, Körber Pharma Software

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 2025¹. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Cell and gene companies* are emerging from years of laboratory scale development through preclinical tests and pivotal clinical trials to ultimately reaching FDA approval and commercialization. Digital solutions such as a robust Electronic Batch Recording system (EBR) are vital. Given that the raw material for these processes are actual patient cells extracted in a clinic; a failed batch is devastating and could mean loss of a patient’s life. A failed batch due to poor paper record handling must be avoided at all costs.

A crucial component in reducing Cost of Goods Sold (COGS) in developing cell, gene and stem cell therapies is through increased efficiency of the manufacturing process. Automation provides a suitable option to address this challenge. Those manufacturers who have become early adopters of digitization, automation and continuous improvement are reaping huge benefits.