Linker PayloadsBioconjugates and Antibody Drug ConjugatesAnalytical Method DevelopmentFormulation DevelopmentProcess Development

Linker Payloads

Adding value to your bioconjugation program

We identify and develop an optimized process for the selected lead linker-payload design across a diverse range of toxins.

Our capabilities include:

  • 100ml to 100L jacketed glass reactors allowing for efficient scale-up and ability to develop accurate scale-down models
  • Non-chromatographic purification methods such as precipitation and crystallization
  • Teledyne-Isco Torrent medium pressure chromatography systems capable of both normal and reversed phase purification up to 3.8kg columns
  • Novasep Hipersep high pressure chromatography skids capable of batch purification of more than 1kg of material in a single processing day

By applying our expertise in highly potent small molecule process development, we utilize a Design of Experiment (DOE) based approach.

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Linker-payload processes are developed and transferred directly to our cGMP manufacturing team minimizing challenges seen during process transfers.

We develop the most effective processes for manufacturing at toxicology, clinical, and commercial scale using quality by design (QbD) principles.

Our expert knowledge of cGMP manufacturing enables us to successfully transfer existing processes into our facilities or develop a new innovative process, when needed, to meet your program needs.

Processes follow ICH Product Lifecycle guidelines which ensure a robust and well characterized scalable manufacturing process.

Utilizing analytics, we ensure the right product quality attributes for your program.