Process Development

Formulation Development

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Our formulation scientists will establish conditions that suit your product.

• Drug Substance.
• Drug Product.
• Liquid and Lyophilized formulation.
• Preformulation and excipient screening
• Stress studies including freeze/thaw, extreme pH, elevated temperature, and light exposure.

Separate areas are provided for upstream development, downstream development, solution preparation, stability, and analytical development.

• Three cell culture rooms for media development.
• Controlled-rate freeze system for cell banks.
• Quarantined Research Cell bank (RCB) storage.
• Cell culture bioreactors from 2L to 200L for process development, optimization, and production of gram-quantities.
• Filtration, chromatography, and ultrafiltration purification systems from milligram to gram quantities.
• Full analytical support including Mass Spectrometry (LC-MS).
• Formulation development equipment including controlled-rate freeze/thaw and pilot lyophilization.

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