Process Characterization
Client Audits Globally
Cost Reduction
Commercial GMP Manufacturing Scale
BLA-enabling CMC Service
Tech Transfer
0 Months*Process Optimization
Clinical Sample Manufacturing
5 MonthsProcess Characterization
6 MonthsProcess Validation
14 Months*CMC Documentation Prep For BLA
PAI
Commercial Manufacturing
Translating Late-Stage Development into Commercial Success.
Talk to an Expert* The time of process optimization varies depending on the project. The period of 14 months excludes process optimization.
Resources
FLYER
BLA Service
Late Stage Process Development and Commercial Manufacturing Service.
HAND
BOOK
BOOK
Process Characterization and Process Validation Guide
Practical guide to defining robust processes for BLA-ready biologics.
WHITE
PAPER
PAPER
Late-stage Process Development and Cost of Good Reduction Strategies for Biologics
Cost reduction strategies for efficient biologics manufacturing.
FLYER
GMP Manufacturing Solution for Antibody and Protein Drug
Drug substance GMP manufacturing and aseptic fill/finish.
Frequently Asked Questions