By Leah Kinthaert
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.
|Moe Heidaran on the benefit of CGMP|
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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