NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Here is a conversation that took place two months ago:

John Warner, Managing Director Sure-Green Ltd.

2mo ago
Looking forward to seeing Advent progress to the next level

Reply
Comment on John Warner’s comment

Mike Scott, Chief Operating Officer at Advent Bioservices & Visiting Professor, Anglia Ruskin University.

2mo ago
Thanks John, all going in the right direction

So, all going in the right direction!

I'm patiently waiting and I’m hopeful that Advent and Sawston will be certified in the coming days or weeks.
Meanwhile there is increased regulatory scrutiny over the fabrication practices of cell and gene therapies.
Here is an interesting read about Cell & Gene Therapy Manufacturing.

“Because, in Cell and Gene Therapies, the process essentially is the product, agencies have a duty to look more closely at the quality and consistency of the manufacturing to ensure that the therapies always remain safe for patients”

Ana Hidalgo-Simon, Head of Advanced Therapies at the European Medicines Agency (EMA)

“The major issue here is comparability, because this field is so very new and the manufacturing processes being deployed vary so greatly. These changes need to be made in an extremely controlled and recorded manner so that we can evaluate and compare processes and so that we can use all the data collected linking all stages of development to the final product,”

Ana Hidalgo-Simon, Head of Advanced Therapies at the European Medicines Agency (EMA)

https://pharmaboardroom.com/articles/reconsidering-cell-gene-therapy-manufacturing/

“Ultimately it’s a journey of discovery and experimentation. We are learning and fine tuning all the time. One of our early realizations was that we should establish a balanced mix of in-house manufacturing capabilities and external partnerships”.

“We require the former because it’s important to build and master that manufacturing expertise ourselves, but it’s equally critical to enrich and complement that home-grown knowledge with outside impetus and ideas from around the world

Stefan Hendriks, Global Head of Cell and Gene, Novartis Oncology.