Process Development Services

Clone screening

Stability
indicating tests

In-vitro potency

Pre-formulation
studies

Upstream &
Downstream
assessment

Manufacturability
assessment

Analytical
Development
and
Qualification

Platform
methods and
New development

Product release &
Stability testing

Platform and
Customized
Process
development
-mAbs

Process
intensification

Material
Equivalency
studies

Process
Development

Process
Characterization
(PC)

Scale-down
model

Downstream PC
studies

Useful resin
life studies

Scale-down
model

Exploratory &
Regulatory
studies-Phase 1
(actual VC
outsourced)

Worst case
scenario studies

Virus clearance
studies

Formulation
development
and Stability
studies

Pre-formulation
studies

Formulation
screening for mAbsPlatform &
Comprehensive

High concentration
mAb formulation

Filter adsorption
studies