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What we offer
From mammalian Cell line development to cGMP commercial manufacturing we will be at your service to deliver qualitative and cost effective mAbs.
We mitigate your cost of burden by offering both Drug Substance and Drug Product of mAbs for clinical trails and commercial production without any compromise in Quality
Our diversified technology platforms, customizable solutions, state-of-the-art infrastructure will amplify your clinical and commercial success for mAbs.
We work purely on a contract basis protecting the intellectual property of the clients at any or all stages of biologics development
We enforce strict adherence to regulations required for cGMP biopharmaceutical drug substance and drug product manufacturing.
CELL LINE DEVELOPMENT
Gene synthesis
Transfection
Clone screening and selection
Stable pool generation
Single-cell isolation and cell viability
Clone productivity screening
Primary Cell Bank Generation
Mono-clonality assurance
Cell line stability studies
PROCESS DEVELOPMENT
Upstream and Downstream Process Development
Media and cell culture optimization
Identification of Critical and Key Process parameters
Analytical methods to identify CQA’s
Head to head comparability studies
DS and DP stability studies
DS MANUFACTURING
cGMP manufacturing in compliance with global regulatory guidelines
cGMP Mammalian cell banking
cGMP Mammalian manufacturing up to 2KL
Clinical & commercial manufacturing
Single use bioreactor systems
ASEPTIC FILL FINISH
3 in 1 combo filling line
Liquid fill vials catering the range of 3 ml, 20ml, 50ml
Lyophilized vials filling unit with a shelf area of 70 sq.ft
Prefill syringes featuring a capacity of 0.5ml
Contact us to find out more
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