Request-Details

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Looking for CMO, bio-molecules conjugation, API manufacturing, potentially filling and packaging FPP

  • Contract manufacturing, filling and packaging
  • Biopharmaceuticals
  • Worldwide
  • 02/25/2017

Description

We are looking for cGMP certified CMO (wordlwide) able to conjugate 2 bio-molecules (an enzyme modification) and purify the product. The product can be provided to us in form of API or even better used to produce FPP at the same facility (filling and packaging of a simple API's formulation). We prefer full service (API and FPP) but can settle for API alone.

We have active small scale GMP manufacturing (conjugation, purification, fill finish and analysis of API and FPP) but we are looking to upscale it. Technology is ready to be transferred and validated at destination site.

Requirements

  • GMP certified
  • Able to work with NaCNBH3 (reductive amination chemistry)
  • Ability to perform subsequent purification by 1) Hydrophobic Interaction, 2) Anion Exchange Chromatography and 3) Ultra-filtration

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