Vaccine - Lyoinnovation

Challenges of Lyophilized Vaccine

Complex preparations, especially vaccines composed of multiple strains or antigens, may lead to challenging critical temperatures and complex freeze-drying processes.

Advantages of Lyophilized Vaccines

● Accurate-dose

● Maintain the physical and chemical properties and biological characteristics to the greatest extent

● Good solubility and reconstitution

● Aseptic operation, less pollution, good clinical application, less allergy

● Long distance transportation and long-term storage

● Reduce the cost of cold chain transportation and extend the shelf life

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Sample Analysis

Formulation Optimisation

Trial Cycle

Cycle Development

Scale-up for Production

• Formulation Characterization

Microscopy and Thermal Analysis in Formulation Characterization: Eutectic temperature (Te)、Collapse temperature (Tc)、Glass transition temperature (Tg'、Tg)

• Cycle development/ Technology transfer/Scale-up

Using process analysis technology (PAT)

• Cycle Optimization

SP Hull LyoStar™4.0 with Smart™ and ControLyo®

• Small batches production

LyoConstellation™ scale freeze-dryers, Ultra Pilot and Small Production Lyophilizer

• Final Product Analysis

Quantifying Lyo Cake Robustness, Karl Fischer moisture determination method

• Training and consulting services

Downloads

Impact of the Freeze-Drying Process and Lyoprotectants on Nanoparticle Stability

Nanoparticles are extremely diverse, ranging from solid lipid structures to liposomes and even designs that incorporate gold/silica particles.

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Freeze Drying of Vaccines – Challenges and Concepts in Formulation and Process Development

There are still millions of people who die from these diseases due to weak thermostability demanding cold chains, long-term stability issues and distribution challenges.

pdf | 486.87k

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