Two groups look to bring stan­dard­iza­tion to cell ther­a­py man­u­fac­tur­ing in their lat­est pa­per

As cell ther­a­pies are be­com­ing used more and more in med­i­cine, two groups are look­ing to stan­dard­ize cell ther­a­py man­u­fac­tur­ing so it can even­tu­al­ly be­come more wide­ly avail­able.

The Al­liance for Re­gen­er­a­tive Med­i­cine (ARM) and the Na­tion­al In­sti­tute for In­no­va­tion in Man­u­fac­tur­ing Bio­Phar­ma­ceu­ti­cals (NI­IM­BL) have re­leased a pa­per called Project A-Cell, a col­lab­o­ra­tion meant to an­a­lyze how to in­cor­po­rate Qual­i­ty by De­sign (QbD) prin­ci­ples specif­i­cal­ly in the man­u­fac­tur­ing of CAR-T cell ther­a­pies.

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