Vesco Science

기술

맞춤 제형 개발

농도, 제형, 포장, 문서 요건까지 고객 요구에 맞춘 개별 개발.

Technology

Custom Formulation Development

Different biological materials require different formulation strategies. Vesco Science supports custom formulation development in which the formulation architecture and processing conditions are established according to defined technical requirements. Custom development can begin with a target product profile and progress through laboratory formulation screening, optimization, process development and stability evaluation.

Parameters

Custom Development Parameters

Development Area
Examples
Active concentration
Target concentration and loading
Molecular composition
EV, PN/PDRN, peptide or HA components
pH
Buffer-system optimization
Osmolality
Physiological compatibility considerations
Viscosity
Injection/application characteristics
Physical state
Liquid, frozen or lyophilized
Stabilization
Excipient and process optimization
Reconstitution
Time, clarity and dispersion
Packaging
Vial, syringe and container compatibility
Storage
Temperature and stability requirements

Process

Development Cycle

01

Target Definition

Establish the desired product characteristics

02

Raw Material Evaluation

Assess identity, quality and compatibility

03

Formulation Screening

Evaluate different concentrations, buffers and stabilizing systems

04

Process Optimization

Establish suitable mixing, filtration, concentration, freezing or lyophilization conditions

05

Analytical Characterization

Measure relevant physical, chemical and biological attributes

06

Stability Assessment

Evaluate product behavior under defined storage conditions

07

Scale-Up Considerations

Assess whether laboratory conditions can be translated into controlled larger-scale process

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