Facilities for Novel Therapies:Demystifying Design and Engineering Requirements for Cell and Gene Therapy Production

摘要

Many veterans of the biologies industry presume that emerging therapeutics such as cell and gene therapies (CGTs) require production facilities that differ substantially from those for monoclonal antibodies (MAbs) and other conventional biologies. Butexperience with designing CGT facilities bears out that far more synergies than differences exist across facilities for conventional and advanced therapies. Herein, I call attention to some of those shared design concerns and demystify facilities and engineering requirements for CGTs.