Freeze & Thaw

The filling and freezing of large volumes for fermentation is an essential part during different production steps in upstream and downstream processing.  In the following, we will explain why it is important to act fast and how an optimization of the process can be achieved. 

As expert for cold chain handling in bioprocessing, Single Use Support is providing solutions to meet challenges for safe storing and shipping associated with right freezing and thawing methods and temperature control for long-term storage. Their development approach leads to innovative systems that enable manufacturers to replace manual processes with fully automated end-to-end processes that not only push efficiency but also increase output.

For drug substances that undergo a freezing process during manufacturing, thawing at some point is only a logical consequence. However, there are several factors to be considered for this seemingly easy procedure – find out more in this article!

Freezing large volumes of drug substance can be a challenging endeavor. In this article, we will discuss main considerations as well as possible solutions for this delicate process.

The global distribution of pharmaceuticals is complex and demanding, requiring precise handling and storage of sensitive products. With the rise of personalized medicine and the increasing globalization of the industry, the need for safe and efficient shipping and supply chain has never been more important.

By combining a number of benefits, single-use technologies that are compliant with cGMP and GAMP seem the perfect choice. For manufacturers of drug substances, they provide a more efficient, cost-effective, and scalable solution than stainless-steel tanks by offering. 

Both, CDMOs and CMOs, are offering major opportunities in biopharma for startups and emerging companies as well as for established players who are approaching the limits of their manufacturing facilities or are generally looking to outsource parts of or their entire commercial production. 

What's the best choice for long-term cold storage of valuable drug substance? Comparing different Biopharma technologies.

One would think that a sector like the fast-paced biomanufacturing industry could not get any faster. Yet, increased speed-to-market and ever more efficient manufacturing continue to drive product and process development. This is why single-use technologies have become increasingly popular. Read more about single-use systems for downstream processing in this article. 

Upstream and downstream processing are two steps inherent to the production of active pharmaceutical ingredients (API) used in biopharmaceuticals. The production is challenged by increasing regulation and manufacturing costs. This calls for flexible solutions, which is why a growing number of manufacturing processes utilize single-use systems

Freezing and Thawing drug substances in both primary packagings, single-use bags and bottles, in one platform is possible with hybrid freezers. Biopharmaceutical manufacturers and CMOs face challenges to prevent the effect of cryoconcentration during freezing, leading to loss of product quality. Tests have shown that hybrid freezer defy cryoconcentration with homogeneous freezing of both single-use bags and bottles.

To control cryogenic freezing is not an easy task, especially when liquid nitrogen is involved. To keep small molecules chemically stable and prevent chemical degradation, the right practices have to be in place. Find out everything about controlled cryogenic freezing with LN2 in this article!