Quality Alchemist (品質煉金術師): HKSQ Seminar – Quality Considerations on Cell Banks

2023年12月8日星期五

HKSQ Seminar – Quality Considerations on Cell Banks

HKSQ and TQM organized seminar named “Quality Considerations on Cell Banks” on 8^th Dec 2023. CQI is supporting organization. Advanced therapy products (ATP), such as CAR-T and stem cells, provide an exciting new class of therapeutics. As the number of cell banks both in development and approved continue to increase, this seminar is a fantastic way to learn more about the quality considerations in the industry, and the means to control associated risks and to ensure safe cell sources, product quality and patient safety. Before the seminar, Ms. Minda Chiang and I took a photo in front of the presentation topic.

Then we took a group photo with Dr. Jane Wong (Chairman, HKSQ) and Dr. Aaron Tong (Former Chairman, HKSQ).

I met Dr. David Ho (Laboratory Director, Celvita Cell Technology Company Ltd.) who knew this seminar was referred by Mr. Dominic Lam (CMA Testing).

Minda met her old colleagues Mr. Harry Yeung and Ms. Athena Chan.

In the beginning, Minda briefed some glossary such as human cells, tissues, and cellular and tissue-based products (HCT/Ps). Then she said the seminar focused on four topics and they were operational flow & critical controls, QA, Challenges in Cell Banks and Enablers.

She firstly briefed the operation flow from donor recruitment to collection to manufacturing and then to transplantation.

And then Minda mentioned three critical control including Personnel, Process Control and Quality Control. During contact donor, we should welcome, appreciate and respect all people including sexual minorities.

The second topic is QA. She introduced the most common accreditation programs in this industry including GMP, AABB, AATB, FACT, ISO 15189, ISO 20387 and CAP.

Three of accreditation programs (AABB, FACT & AATB) covered from Donor to manufacturing and then to the patient.

Finally, Minda shared some challenges in cell banks. They are regulations, infectious disease panels, experienced people, novel technologies, etc. Lastly, she introduced HKSQ as enabler to provide workshop on QMS in Cell Banks.