Freeze & Thaw

Prior to be used in diagnostics or therapeutics, proteins have to be safely stored. In this article, we will assess methods to preserve their stability upon storage.

Protein stability is crucial to be maintained along the manufacturing process of protein-based products. In this article, we will discover what influences protein stability, along with methods to assess and increase it.

Active pharmaceutical ingredients (APIs) are fundamental for drug products to be effective, but require special treatment – e.g. considering humidity, light, or temperature. In this article, we will highlight the different cold storage requirements of APIs, including examples and an overview of different practical approaches.

The objective of an optimal cryopreservation strategy is to deactivate (put on hold) degenerative cellular pathways and preserve proliferative potential by reducing the temperature below –130°C. To reduce the effects of ice crystal and osmotic injuries, cryopreservation protocols usually incorporate cryoprotective agents (CPAs).

Freezing small volumes extends beyond laboratory settings to include commercialized manufacturing processes for small batches in biomanufacturing, like cell banking, gene therapies utilizing viral vectors, lipid nanoparticles, and fill & finish procedures.

In the biopharmaceutical sector, the utilization of F-Gases is on a decline. However, the need for cryopreservation of drug substances will remain. In order to contribute to a more environmentally friendly freezing of drugs, more sustainable technologies need to be developed and applied. But is sustainable freezing even possible?

The preservation of cells at cryogenic temperature can be achieved using different techniques. This is far from a simple freezing process; it's a carefully controlled method that prevents the formation of ice crystals, thus maintaining the integrity of the biological material.

This guide provides an overview of the necessary steps and considerations for preparing cells for cryopreservation. Key topics include selecting appropriate cells, cultivating and harvesting them under controlled conditions, utilizing proper cryoprotective agents, and applying specific freezing techniques.

Cell thawing is a critical procedure in the area of life science and medicine. Ensuring a gentle thawing of frozen cells is essential for preserving their viability and functionality. In this article, we will highlight the cell thawing process, discuss common challenges, and provide recommendations for achieving optimal results in cell banking. 

It is many decades since cryovessels emerged as a groundbreaking solution in the biopharmaceutical industry, enabling the safe and efficient storage of bulk drug substances. However, the introduction of plate-based freezing methods has further advanced the technology available for the freezing of biopharmaceuticals, offering improved product quality and consistency.

Not all biopharmaceuticals are suitable for freeze-drying. Depending on the specific stability requirements the preservation of biopharmaceuticals is either with cryopreservation or lyophilization.

New technologies, sauch as plate-based freezing and thawing based on single-use systems, improve process efficiency and product quality. Innovative solutions are breaking the ice for the evolution of bulk drug freezing.