Replies to post #239459 on NorthWest Biotherapeutics Inc (NWBO)

[maverick_1]

sukus re:

I agree that they are very challenging. I also agree with your conclusion.

https://www.genengnews.com/insights/scaling-up-cell-therapy-manufacturing/

NOW I know sukus has been doing his OWN critical spadework of extra due diligence!

Been aware of how difficult it is for the mfg of cell generated therapy: began with my 2016 posts here on UK's Catapult.

More recently:

flipper44 Member Level Thursday, 03/21/19 12:15:43 PM
Re: None
Post # 219358 of 239465
Quote:
....Reporting to the Sr. Director of Quality/ Site Head of Quality, the Director, Quality Control – Analytical will be responsible for management and oversight of a large QC Analytical staff and multiple Laboratories in a Cell and Gene Therapy contract manufacturing facility producing Phase 1, 2 and 3 clinical cell and gene therapy products and is anticipating manufacturing commercial products. -- 72 hours ago. Cognate Bioservices.

Hbpainter Thursday, 03/21/19 12:26:20 PM
Re: flipper44 post# 219358
Post #
219360
of 239465
Very interesting, more so than the latest one from Advent Bioservices:


Summary

Job Title: GMP Production Scientist
Location: London
Salary: £38,000 per annum
Job Type: Permanent

Posting Date: 20/02/2019
Closing Date: 22/03/2019

An exciting opportunity has arisen to join an emerging contract bio services organisation providing GMP manufacturing services and process development for novel cell and gene therapy products. This is an exciting role for a high calibre cell therapy GMP Production Scientist. The GMP Production Scientist will report to the GMP Production Manager.

The GMP Production Scientist will be responsible for performing batch manufacturing of the company's contract manufacturing products to support the delivery, in the first instance, of Advanced Therapeutic Medicinal Products (ATMPs) as both "Specials" and as Investigational Medicinal Products (IMPs).

The post holder will work closely with GMP Production Scientists and Quality Assurance staff and facilitate the efficient delivery of cellular therapy products for clinical use.

Responsibilities:

The role includes but is not limited to:
• GMP production within sterile environments, formulation and banking of cellular therapy products. This will include cell culture and raw material support in compliance with validated standard operating procedures (SOPs) and regulatory requirements
• Perform and assist in the development of QC assays as part of product release, including use of flow cytometry, ELISA and ELISPOT assays, microscopy techniques, cell culture, SDS electrophoresis
• Preparing technical reports and other clinical and GMP required documentation including but not limited to batch production records (BPRs), SOPs, equipment validation and deviation reports
• Support in process engineering and validation of cellular therapy products for successful technology transfer into the facilities with full GMP compliance
• Plan and undertake validation of new production equipment used in GMP manufacture
• Undertake daily GMP production housekeeping activities and administration, including but not limited to cleaning, stock control, ordering materials and managing suppliers
• Assist in the labelling, packaging, storage and shipping of cellular therapy products and maintenance of product inventory


GMP Production Scientist

https://g.co/kgs/aTQZH8

DIFFERENT STROKES FOR DIFFERENT FOLKS

[Doc logic]

sukus,

Perfect post to demonstrate how the "art" of manufacturing cellular products has not yet been perfected or understood and that because of this there is leeway given such that "optimization" becomes a reality as the processes and relationship of purity and equality of aliquots to efficacy become better understood by everyone involved over time. In other words, if purity, quality and equalized distribution have improved over time then a relationship to efficacy might eventually be noted. What happened to 3 year data: )? Best wishes.