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| Cell Therapy Bioprocessing & Commercialization attendees heard from a range of speakers on getting treatments to market |
By Leah Kinthaert
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| Novartis's Knut Niss shared his insights |
FDA biologist Moe Heidaran
PhD told attendees on the closing day of Cell Therapy Bioprocessing &
Commercialization about the benefit of current good manufacturing processes
(CGMPs) in the commercialization of cell therapy treatments.
Heidaran told a rapt crowd:
“Efficacy of a product can be readily established if a product can be
manufactured consistently with the highest quality.” He explained that, along
with CGMPs, “in-depth knowledge of product is needed for high-quality product manufacturing”.
He stressed that quality
control is the “most important part of CGMPs”.
“Becoming CGMP compliant is a process,” he said, adding: “It is never
too early to plan.” Heidaran told the audience to be stay up to date with the
FDA’s ICHQ6B guidance.
Heidaran moved on to focus
on process change. He noted: “Process change is inevitable and not all of it is
planned.” He said that, for a major process change, the FDA needs an amendment,
while minor changes can be documented in an annual report. If unsure, a CMC
reviewer could advise if a change was major or minor.
He described the time
sensitivity of reporting changes: “Post licensure reporting categories have a
time limit of four months if they are PAS, while the timeline for review is six
months if they are in the category of CBE or CBE-30.” He told the audience they
should refer to ICHQ5E for more information and said there was the potential
for either clinical or non-clinical data to be required.
Heidaran affirmed the
importance of the FDA’s established controls for cell therapy products,
explaining their value in his closing remarks: “Change is inevitable, it’s the
most critical part of product improvement. Innovation is coming into the cell
therapy market, manufacturing is becoming a huge issue. Controls are not
designed to be troublesome or obstructive, but to allow you to recognize
challenges you have to meet to have a success strategy for commercialization.”
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