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Drug Product cGMP Manufacturing

CAPABILITIES

We provide cGMP Drug Product manufacturing services for liquid Vials, lyophilised Vials and PFS.

Fully automated final drug product formulation and filling under cGMP conditions as per the worldwide regulatory agencies including USFDA, EMA, and ROW markets.

Capabilities

Supplying commercial mAb drug products for the APAC market (customers include US and Indian MNCs)
Liquid vials, Lyophilized vials and PFS
Vial sizes from 2ml to 50ml
Integrated vial filling line from Bausch+Ströbel
Lyophilizer: 80 sq.ft. shelf area
Pre-filled syringes
An integrated automated syringe filling and stoppering system from Optima, Germany, equipped with an Isolator for highest level of sterility assurance.
1. Line speed Upto11,000 units per hour, catering to fill volumes ranging from 0.5ml to 5ml.
2. Component sizes1ml to 5ml syringes. Other components (including cartridges) possible with additional change part.

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+91-8026982400

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Biologics Development
Biologics cGMP Manufacturing
Quality Control
Integrated Services
Formulation Development

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Kemwell Services Overview
Process development
Analytical Development
cGMP Manufacturing
Stability Studies

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About
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Services

Biologics Development
Biologics cGMP Manufacturing
Quality Control
Integrated Services
Formulation Development

Download Brochure

Kemwell Services Overview
Process development
Analytical Development
cGMP Manufacturing
Stability Studies

cGMP Manufacturing

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Approach to Scale-up of Fed-batch
Cell Culture Processes.

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Scale-up of Fed-batch Mammalian Cell Culture Processes

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Kemwell’s Expertise in Size Exclusion Chromatography for Isoform Separation of a Novel Tri-specific Antibody

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Kemwell’s Approach to Considerations for Selecting Hydrolysates in Cell Culture Processes

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Kemwell Pharma

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