ell therapies are anticipated to be the next
breakthrough to address unmet medical needs.
ough use of cells as therapeutic agents such as bone marrow transplant has been in
medical practice for decades, cell therapy regulati
ons are relatively new, or emerging in most
countries and regions, including the US and the EU.
In this evolving regulatory environment, how cell therapy tools are regulated is not straight
forward. Wave, a bioreactor intended for expansion of human cells in suspension, has been on
the market in the US and Canada. Since cell therapy is regulated similarly as drugs or biologics
in the US and Canada, Wave Bioreactor is regulated as manufacturing equipment but not a
medical device, the same as for biologic ma
nufacturing equipment. A Drug Master File for
Wave has been fi
led at the FDA and cross-referenced by INDs cleared to initiate clinical trials
for testing investigational cell therapy products.
While cell therapy development is advancing around the world, particularly in Asian Pacifi
countries, the demand of an automated, scalable bioreactor such as Wave for manufacturing
cell therapy product has increased. However, due to unclear or evolving regulations in these
countries, confusions arise on whether Wave bioreactor should be regulated as equipment or a
medical device. As the author works with individual countries to map out regulatory pathway for
Wave, it has become clear that a harmonized regulatory requirement for cell therapy products
and cell therapy processing tools are critical to bring innovative cell therapies to patients in
Jiwen Zhang received her Ph.D from the joint Physiology and Neurobiology program at Rutgers University and
University of Medicine and Dentistry of New Jersey. Currently, she is a Regulatory Affairs Director for Strategic
Initiative at GE Healthcare. Before joining GEHC, she had worked in pharmaceutical and biotech industry as
a regulatory affairs professional developing biologics, small molecule drugs, and cell therapies in different
therapeutic areas. Jiwen has taught RA courses at universities and given presentations at industry symposiums
on drug development and regulatory strategies.
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