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Application of Tunable Diode Laser Absorption Spectroscopy (TDLAS) to Monitoring Pharmaceutical Lyophilization

This technical brief provides an overview of Tunable Diode Laser Absorption Spectroscopy (TDLAS) and its application for monitoring freeze drying processes.

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Basic Principles of Freeze Drying

Freeze-drying is the removal of ice or other frozen solvents from a material through the process of sublimation and the removal of bound water molecules through the process of desorption.

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Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods

The objective of this investigation was to evaluate two methods for measuring the maximum sublimation rate that a freeze-dryer will support—the minimum controllable pressure method and the choke point method.

pdf | 955.96k

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Failure of Glass Tubing Vials during Lyophilization

Lyophilization consists of changing a liquid pharmaceutical product into a dry solid “cake” by means of a freeze/dry process.

pdf | 2610.35k

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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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PCR Diagnostic Kits & Freeze-Drying Considerations

Polymerase chain reaction (PCR) is a method widely used in molecular biology to make many copies of a specific DNA segment.

pdf | 430.79k

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Rational Design of Stable Lyophilized Protein Formulations

Why use lyophilization to prepare stable protein drug products?

pdf | 1598.96k

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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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冻干样品配方的关键温度的测量

在进入冻干工艺的开发前，对配方的深入研究是极有必要的。研发人员必须保证配方中的活性成分在整个冻干周期中都能保持稳定，来保证得到的产品有着良好的外观和性能。

pdf | 3834.71k

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技术前沿｜冻干过程中微塌陷如何影响冻干产品的强度？

在冷冻干燥过程中，产品应保持在其关键温度以下，如玻璃化转变温度(Tg’），共晶点(Teu)和塌陷温度(Tc)，以确保一个安全和稳健的循环，并减少产品冷冻干燥后出现的有害缺陷的风险。缺陷可能包括但不限于产品内的物理塌陷或微塌陷、活性丧失和高水分含量。

pdf | 1657.03k

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