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Resin Recycling Studies

Project Outline

Analytical Method Transfer Protocol(s)
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Analytical Methods Establishment
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Scale Down model Protocol
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Scale Down Model Establishment
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SDM report
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Resin Cycling protocol(s)
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Study execution Sample analysis Data collection
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Study report

Documentation

  • Activities are carried out with formal protocols
  • The protocols are discussed with, reviewed by and signed o by the client prior to initiation of experimental work
  • Protocols will include procedures as well as acceptance criteria
  • Reports are finalized after client review and sign-o by client
  • Client has the flexibility to arrange data and report in their format

Data

  • 100% data verification is done by the QA personnel
  • All the raw data shall be available for client review and the same will be shared with client after study completion

Materials

  • Pre-approval of complete list of materials by client before initiating procurement
  • All residual materials and the used resin can be shipped back to client

Project Timeline

DescriptionTimeline
Analytical method transfer12 weeks
Baseline runs3 weeks

 

Chromatography resinNumber of runsTimeline
Protein A chromatography (PAC)240 Runs18 to 20 weeks
Ion exchange chromatography (IEX)120 Runs11- 12 weeks