NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Happy Thanksgiving Everyone!!

Lykiri, any chance Mike Scott has made any recent public comments across the pond.

Flipper44,

The number of vacancies has never been higher.
They are looking for:

Two Cleaners (Part Time, 25 hours p/w)
Biobank Manager
GMP Production Scientist
Process Development Scientist
Quality Assurance Officer
Quality Assurance Validation Technician
Senior Production Scientist
https://adventbio.peoplehr.net/JobBoard/

They are mainly looking for production scientists.

Kelly Balsom- Advent Bioservices
1 week ago

We are recruiting PRODUCTION SCIENTISTS to join our cellular therapy manufacturing team in Sawston, Cambridge. If you interested please take a look on our website

Advent Bioservices is also looking for a Technician Scientist Apprentice (Level 5).

The purpose of the Technician Scientist Apprentice is to support the batch manufacturing of the company’s commercial products, to support the delivery of Advanced Therapeutic Medicinal Products (ATMPs) as both ”Specials” and as Investigational Medicinal Products (IMPs).
Closing day : Nov.29, 2021
https://www.findapprenticeship.service.gov.uk/apprenticeship/reference/1788763

Interesting here is the possible start date: Jan 10, 2022

A few weeks ago I asked several MHRA Inspectors for more information about pre-approval inspections in the UK.
Meanwhile, I know that the MHRA do not perform pre-approval inspections as per the FDA.
Recently I received a reply from one of the MHRA Inspectors.

Hi XXXXX

We don’t routinely perform pre-approval inspections. If a submission is received for an MIA and MIA(IMP) we would do a single inspection for both licences and (if successful) the GMPc would be issued for each. The statutory timeline from acceptance of the application is 90 days. The site must be inspection ready at the point of application and this blog might be helpful https://mhrainspectorate.blog.gov.uk/2017/01/05/helping-us-to-help-you.
Kind regards

It's an interesting read: https://mhrainspectorate.blog.gov.uk/2017/01/05/helping-us-to-help-you/

I asked the MHRA Inspector if the original inspection timing of new facilities in the UK are delayed by MHRA due to their caseload or something else.
I gave the Sawston facility as an example of the delay.

Reply from de MHRA Inspector:

Hi XXXXX
Can you provide the name and address of the facility and I can look into this for you.
Regards

I sent the adress:

Registered office address:

Sawston Business Park, Sawston, Cambridge, United Kingdom, CB22 3JG

CDMO: Advent Bioservices

Reply from the MHRA Inspector:

Hi XXXXX

The site has been inspected but the inspection is not yet closed so the licences are still pending.
The 90 day clock is paused at any point where MHRA are awaiting information from the company (for example: queries arising from, or omissions within, the initial application or the time taken for responses to any inspection findings ) so the 90 days isn’t necessarily 90 calendar days.
If you need any more detailed information on timelines regarding the issue of the licences I would suggest you contact the company directly.
Kind regards

I see it as a positive that i didn't get the usual comment like "Due to commercial confidentiality we are unable to advise on specific applications or inspections".
Happy Thanksgiving flipper44!