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Measuring the gene copy number per cell for gene therapy drug products

Request Number N477108
Need details
Description

GSK is seeking rapid, point of care analytical tests for gene therapy products that can go from sample to result within 2 hours

 

Tests should work with human cells at a concentration of 1x106 – 1x108 cells per mL in growth media. They should measure the gene copy numbers per cell in the sample.

 

Lab tests are welcome. GSK would be especially interested in analytical techniques that could be carried out at or close to the patient’s bedside.

 

 

Background

With autologous ex-vivo gene therapies, every batch of drug product is custom manufactured and dosed to each individual patient. Treating 100 patients per day will require 100 drug batches to be manufactured, tested and released per day.

 

As the patient’s condition can deteriorate rapidly, drug batches must be tested and released for use quickly, ideally within one week of manufacture.

 

Current analytical methods rely on laboratory facilities and are labor intensive requiring significant analyst time.

 

To measure gene copy numbers per cell currently requires an analyst to carry out DNA purification, setting up of the PCR reagents, running of the instrument and interpretation of the data.

 

With common indications, the strategy is to automate the manufacturing so that it is brought close to bedside. Ideally the analytics would be automated and also carried out at / close to bedside to provide rapid sample to result data.

 

 

Key Success Criteria

Reduce the testing time, ideally from sample to result in <2hrs

 

 

Possible Approaches

Point of care tests (diagnostics)

Microfluidic disposable cartridge technology

Approaches not of interest

Automating the current methods

 

Preferred Collaboration types
  • Joint Development
  • Contract Research
  • Technology Licensing
  • To Be Negotiated
Items to be submitted
  • A proposal describing the solution and how the success criteria will be met with the proposed solution
  • A non-confidential description of the technology and a schematic of the solution

 

Point of Contact
Stephen Clulow
Area of Interest
  • Aerospace & Defense
  • Electronics & Electronic Components
  • Manufacturing & Fabrication
  • Medical Products & Services
  • Pharmaceuticals
  • Research Organizations
  • Universities & Colleges
  • Other
Organization
GSK
Due Date
March 15, 2018
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