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Case Study

Peptide Discovery

Peptide CMC

Peptide Conjugation

Amino Acid

Case Study

Peptide CMC

Peptide Discovery

Peptide CMC

Peptide Conjugation

Client:

  • a biotech company in the US

Project:

  • API process development and manufacturing

  • Formulation development and manufacturing

  • CMC writing for IND filing

Challenges:

  • Extremely tight timeline: tox study in 4 months and IND filing in 10 months

  • Technical challenge: low yield from original route

  • Supply challenge: very limited amount of raw material

Solution: Only integrated CMC development can possibly meet such an aggressive timeline

  • Developed a new route within 1month; reduced reaction step from 30 to 25; purity increased to 50%; overall yield is 4 times higher

  • With only 5 gram of API, developed analytical method for 4 weeks

  • With only 7 gram of API, Injectable formulation for manufacturing was developed in just 2 days

  • Completed the DS IND Module 3 dossier 4 weeks after GMP API batch was released


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