Cell therapy GMP is really a "great" challenge

On January 6, 2022, the Good Manufacturing Practice (GMP)-Cell Quality Product Addendum (Draft for Comment) was released.

It is estimated that this should be the last consultation before the official release.

The content of this GMP appendix should be subversive compared to the previous version of the draft for comments.

It can be seen that NMPA is also determined and ruthless.

The biggest focus of the GMP appendix is ​​the management of the hospital side, which really covers the whole life cycle management from collection to recycling.

The management of donor materials is listed in a separate chapter: Chapter 5 (Donor Screening and Donor Management), a total of 11 articles are stipulated, and it is clear:

1.

2.

3.

4.

5.

6.

As autologous CAR-T cells, it must be managed in this way.

It is absolutely the right move to manage the hospital side well, but the biggest trouble for the enterprise at present is how to manage the hospital side well? It is inconvenient to say more about the management of the hospital, but I can only say: if you go to the hospital, you will know

Hospitals can ignore GMP, let alone comply with GMP requirements.

Hospital or enterprise, who is stronger? The reality of society has to consider the interests of this

In addition to the difficulty of hospital-side management, the electronic drug traceability system is also a great challenge.

From the order system to cell collection, and then to the cell production base of the manufacturer, after sorting and purification, T cell activation, CAR gene transduction, and CAR-T cell expansion to a certain amount of cells in vitro, cleaning, preparation, cryopreservation, Detected, released, and then transported back to the medical institution in the cold chain, and the CAR-T cells will be returned to the patient by the medical staff
.

In this process, all-round management and control are indispensable.
Therefore, it is a highly planned and highly intensive management.
It should be said that 1.
2 million is the price of CAR-T
.

Generally speaking, biological drugs + sterility are the high-end quality management of drug production.
Now, cell quality products will also be transported to patients after blood collection at the hospital and the release of finished products, all of which are managed by the quality of MAH.
Requirements are very powerful
.

remind:

For small enterprises in cell therapy, it is necessary to deploy in advance and build a quality system for the whole life cycle at an early stage.
Not only GMP production plants have GMP, but also GMP for hospitals and logistics;

It can be said that to make cell therapy products, it is necessary to deploy a quality system that surpasses other existing drug types.
If you have any consultation on this quality system, I recommend "Shanghai Yaozhi Technology Co.
, Ltd.
"
.

It can be seen from the draft released by NMPA that the scope of the GMP quality system established by cell therapy companies should be fully extended to the hospital side and the transportation side in addition to the GMP production plant, so as to form a closed-loop full-cycle quality management system for patient treatment.
, in order to meet regulatory requirements
.

Although the content of the GMP consultation draft has very high requirements on enterprises, it can even be said to be extremely high, but from the perspective of protecting patient safety, these requirements are what should and must be done.
, Under the current institutional environment framework, how to really implement it well? It is a great "challenge"
.

Looking forward to one day, the Food and Drug Administration and the National Health Commission can join hands to open up the management boundary from the top, which will be more conducive to the quality control of cell therapy products and benefit the patients who really need it
.