AskBio bails on in-li­censed gene ther­a­py pro­gram af­ter find­ing is­sues with 3rd-par­ty man­u­fac­tur­er

Man­ag­ing a co-de­vel­oped drug isn’t easy, par­tic­u­lar­ly when you add a third-par­ty man­u­fac­tur­ing part­ner in­to the mix. Now, AskBio will hit the ex­its on a li­cens­ing deal with Se­lec­ta for gene ther­a­py pro­gram MMA-101 af­ter find­ing fault with a con­tract man­u­fac­tur­er’s work.

Now in full own­er­ship of its methyl­malonic acidemia (MMA) pro­gram, Se­lec­ta has de­layed fil­ing an IND un­til at least Q4 af­ter iden­ti­fy­ing a “man­u­fac­tur­ing is­sue we be­lieve is re­lat­ed to a com­po­nent sourced from a third-par­ty,” the com­pa­ny said in a state­ment.

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