APR January/February 2022 - 30

»
DRUG DEVELOPMENT
»
industries.
These therapies vary from minimally manipulated
autologous products through to potentially large-scale allogeneic
products
derived from pluripotent
stem cells
of
considerable
complexity. They are rightly subject to stringent regulatory control.
Depending on their classification, they may be under one or more
of the blood, tissue, and cells or medicines pieces of legislation and
their approved guidance documents. However, there are a number
of open issues beyond mandatory requirements. The extent of donor
screening for infectious agents and genetic abnormalities, the nature
and extent of informed consent and the duty of care to the donor
should findings arise which are of relevance to their health, family or
public health. There are also risks associated with the manufacturing
process itself, the characterization of the cellular product and its
behavior in the recipient post administration. The endogenous risks
associated with cellular therapies, particularly with respect to donor
selection, consenting and testing, and to make recommendations
how these can be optimized in order to support the development
of cellular therapies and maximizing donor and patient safety. The
possibility of infection from administered cell therapies remains one
of the greatest risks to potential recipients. The majority of infectious
agents will have a cytopathic effect on the cell line and be detected by
Figure 2. Prespecified Unit-Wise Implementation Approach Enabling Timely Improvements
While Providing Transparency to Regulators.
One Patient
Donor
Figure 3. Autologous Patient Cells Donor Therapy
30 |
| January/February 2022

APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022

APR January/February 2022 - Cover1
APR January/February 2022 - Cover2
APR January/February 2022 - 1
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