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Formulation Development

OUR EXPERTISE

Kemwell offers formulation development services for early and late-stage clinical development and commercial products based on target formulation profiles.

Formulation development work is carried out collaboratively with analytical development groups to ensure that robust and stability indicating analytical methods are used appropriately during formulation development. Real-time, Accelerated, and various stress stability studies are performed to deliver the best formulation for your product.

Preformulation Studies

Evaluation of biophysical characteristics
Assessment of ‘thermodynamic stability’
Identification of critical factors that impact stability

Formulation Screening Studies

Formulation screening studies to select optimal formulation for the molecule
Integrated formulation and analytical method development team to ensure right methods are available for evaluating degradation routes of molecule to enable formulation screening studies

Lyophilization Cycle Development

Lyophilization cycle development for molecules that may have inherently lower stability in liquid form
Optimization of each phase of the cycle to ensure an efficient, robust and scalable process

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Biologics Development
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Formulation Development

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Kemwell Services Overview
Process development
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Stability Studies

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Services

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

cGMP Manufacturing

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

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CULTURE PROCESSES Brochure

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High throughput screening for optimization
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Optimization of purification process

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Kemwell Services Overview

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Stability Studies

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Biologics Development

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Process and formulation Brochure

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Analytical Development Brochure

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Scale-up of Fed-batch Mammalian Cell Culture Processes

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Scale-up of Fed-batch Mammalian Cell Culture Processes

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Monoclonal Antibody Drug Substance

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

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Process & Formulation Development

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Kemwell Analytical Development

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Kemwell Pharma

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