Cell line / Vector development

HEK293 based cell (Suspension/Adherent)

Adenoviral/Lentiviral Vector

Primary Immune cells

Method development

Analytical method optimization

Analytical method validation

From MV protocol preparation to reporting

Support technology transfer of custom assays

Process development

Process optimization (DS-Upstream/Downstream and DP)

Resin / Intermediate(hold time) study support

Automated, closed, integrated process development and manufacturing

Stability studies

Optimization of stability through formulation development for protein and excipient composition

Studies support for a variety of mammalian cell types

Scale up study

Set up of scalable process (Adherent/Suspension culture(5L~50L))

Pilot production

CMC documentation support

Regulatory Affairs Support (Preparing CMC documentation, CTD module 3-Quality part)