PHARMACEUTICAL PROCESSING | APRIL 2015 33 n
n PHARMPRO. COM
CELL THERAPY DRUGS IN PIPELINE
In 2013, a total of 69 cell therapy drugs were in
human clinical trial or under review by the US Food
and Drug Administration (FDA). Out of the 16 drugs
under development certain drugs were used in the
treatment of multiple conditions. E.g. Prochymal,
an allogeneic stem cell therapy developed by Osiris
Therapeutics is being evaluated for several conditions such as diabetes, cardiovascular diseases,
respiratory disorders and transplantation.
The cell therapy pipeline has more number of drugs for
conditions like cardiovascular diseases, cancer and related
conditions. The pipeline as of 2013 had 60% of the drugs in
Phase II trials, 23% in Phase I and 17% in Phase III.
WHAT IS BIG PHARMA’S FOCUS ON CELL
Most of the top pharma companies have partnered with small and virtual companies by in licensing the target molecules.
IMPACT OF CELL THERAPY ON CMO
How is a cell therapy product different from biologic products?
The production of cell-based therapies differs considerably from the traditional pharmaceutical and
biopharmaceutical products. The initial step in cell
therapy requires harvesting cells from a human donor rather than developing the drug from a cell line
or microbial cell. The uniqueness of the raw material and the viability of the cells require clean room
manufacturing and raw material traceability. These
are the major differences between cell therapy manufacturing and biologic manufacturing where the drug
is derived from processing of microbial or cell lines
in optimum conditions.
The CMO market is relatively small with few CMOs
who have commercial capabilities. Biologic CMOs who
can assist in the development and manufacturing of
cell therapy products include Lonza and WuXi Apptech.
Other CMOs like PharmaCell, Roslin Cell, Progenitor Cell
Therapy, MaSTherCell and Cognate Bioservices are focused entirely on cell therapy manufacturing. Owing to
the augmented development in the area of cell therapy
these CMOs have expanded their capacities to meet the
TYPE OF ENGAGEMENT DEVELOPMENT
Most big pharma companies have collaboration with
small companies and academic institutions specialized in
cell therapy development. They either utilize their proprietary technology or support the development and commercialization of cellular therapeutics.