CDO
PCMO has R&D facilities for Small & Large scale's Up/ Downstream and for Analysis.
Based on them, we provide process development and optimization services.
The scope of service
Process Development
Establishment and optimization of upstream (cell culture) and downstream (purification) process conditions
Development and optimization of freeze-drying conditions
Analytical Method Development
Process and quality analysis, testing, and evaluation
Scale-up
-Scale-up of cell culture processes based on working volumes of 50L, 200L, 500L, and 1,000L
-Scale-up of purification processes at corresponding production scales
Fermentation
This area is designed for the optimization and scale-up of upstream cell culture processes for pharmaceutical drug substance manufacturing.
Purification
This area is designed for the purification process development and validation to ensure high product purity and consistent quality.
Lyophilized Formulation Development
Develop stable formulations and establish optimal lyophilization conditions to ensure drug quality.
mRNA Manufacturing
A fully integrated GMP facility enabling end-to-end manufacturing, from IVT-based drug substance (DS) production through LNP encapsulation and formulation to final drug product (DP) manufacturing, supporting clinical trial material supply and mRNA vaccine production.
