Monday, October 5, 2015

CGMPs essential for commercialization of cell therapy products

 Cell Therapy Bioprocessing & Commercialization attendees heard from a range of speakers on getting treatments to market

By Leah Kinthaert

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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