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Rapid analytical tests for gene therapy drug products: completed within one week

Request Number N477108
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Description

GSK is seeking rapid analytical tests for gene therapy products that can go from sample to result in one week.

 

Rapid/high-throughput lab tests are welcome. GSK are 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 growth of cells or microbes in media and can cause a delay of approximately 6 weeks from the manufacture to the release of drug product. In addition, the existing testing methods require laboratory facilities and are labor intensive requiring significant analyst time.

 

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 one week

 

Tests should work with lenti and / or retro virus products and verify one, or more, of the following:

  • sterility
  • absence of mycoplasma
  • absence of residual protein
  • absence of residual DNA
  • detect and quantify cytokines
  • viral titre (colony forming units)
  • infectivity
  • replication competent vector
  • clonogenic potential (viability of infected cells)

 

 

Possible Approaches

Biosensors

Physiochemical surrogate methods

Point of care tests (diagnostics)

 

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
May 8, 2017
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