Case Study

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