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CASE STUDY CAPABILITY

Pre-Clinical to Phase III API Development

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Sai Life Sciences partnered with a leading U.S. Big Pharma company to optimize and scale a highly sensitive C‑terminal peptide containing six stereocenters. The objective was to enhance stage-wise yields, eliminate chromatography in the final step, and ensure high-purity API supply through late-stage clinical development.

Overview & Objective

The project focused on developing a robust, scalable process for a complex peptide API with six stereocenters. The goals included:

  • Achieving ~80% yield at each stage
  • Delivering >98% purity
  • Eliminating column chromatography in the final API stage
  • Enabling smooth progression from pre-clinical to Phase III supply

Approach

To address the complexity and sensitivity of the molecule—particularly given that the final API required lyophilization—Sai Life Sciences implemented a series of targeted process innovations:

  • Developed an alternative purification strategy to eliminate column chromatography
  • Screened protecting groups that improved hydrophobicity and supported acid/base workups for better impurity removal
  • Achieved >80% yield in all stages with final purity >99%
  • Synthesized and characterized 27 process impurities and established comprehensive purge studies
  • Defined process controls and specification limits for all critical impurities
  • Developed and validated robust, specific HPLC methods to support scale-up and regulatory filings

Outcome / Results / Evidence

The optimized process delivered strong technical and operational gains:

  • Consistently achieved >80% yield across stages
  • Final API purity exceeded 99%
  • Successfully demonstrated the process at 20 kg scale
  • Supported Big Pharma’s progression to Phase III with a highly controlled, regulatory-ready process

Key Takeaways / Impact

  • RMC reduced by 44% through process optimization and chromatography elimination
  • High scalability validated, delivering >99.5% purity at 20 kg scale
  • Registration campaign underway, backed by well-characterized impurities and validated analytical methods
  • Strong customer confidence reinforced through scientific rigor and reliable large-scale execution

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