Learn what makes controlled cryogenic freezing such a vital step in the cold chain of the majority of biologics and understand more about different ranges of temperatures and freezing performance.

Join the discussion on how a new proprietary cryoprotectant technology and our a plate-based freeze/thaw unit can be uniquely combined to prepare Cryopreserved Thaw and Use Cell Plates.

Learn how fluid management in biopharma has changed considerably in recent years, and what we do to stay ahead.

Read how single-use technologies and the modular design options they offer can meet the requirements of both laboratory- and bulk-scale production without the need for major adaptations.

Read how single-use technologies are making supply chains more efficient and reduce product loss by providing specific protective technologies, equipped with Pharma 4.0 mechanisms.

We review the pre-use post sterilization integrity testing process and how its compatibility with single-use technology offers advantages compared to stainless-steel systems.

Read how the implementation of Pharma 4.0 standards and SOPs aims to reduce the different types of human error through the automation of processes that have traditionally involved human performance.

These insights provide a brief primer on Pharma 4.0 and will convey the key principles of the digital revolution in the pharma sector.

This article will give an overview of the inline buffer dilution process and discuss its benefits compared to traditional formulation of buffer solutions.

Today's challenges require a move towards agility and change, especially in the biopharma industry. Old-established structures will need to be reconsidered or even restablished and renewed.

Controlling the freezing behavior of bulk drug substance is the ultimate goal in biopharma manufacturing. This study demonstrates the impact of ice front growth speed on scalability of freezing protein solutions.

Supply chain management for CGTs will become increasingly complex to sustain their specific requirements. A much-needed approach to solving problems related to supply chain management is the development of smart packaging and related smart technologies.

When it comes to saving a patient’s life, speed and safety are key – as is the safe handling of the matter, where special protective and coolable packaging play a crucial role.

There is no full Pharma 4.0 manufacturing in place yet, but there are first innovations to build on.

Cell and gene therapies yield a small volume of individualized product for each single patient. Loss of the shipment or damage to the transported goods have serious consequences for patients.

There is still potential product loss with unprotected single-use bags, and there are still human errors dampening the euphoria of single-use systems. Here's how to protect your product investment.

RoSS shells contain 3D foams to protect and immobilize the filled and frozen bags while transporting. In this study we tested the RoSS shell's influence on the sterility on ISO cleanrooms

Single-use technology can simplify the fill/finish process and enable ease of use with custom manifold assemblies, TPE or silicone tubing, and adaptable, widely compatible bags.

Until recently, only isolated solutions for working filling, freezing/thawing and transporting sensitive drug materials were available. Learn how we've addressed this problem with end-to-end bottle solutions.

Plastic totes to carry large 3D single-use bags are widely spread across the biopharma environment. However, they sometimes fail to withstand volumes of biopharmaceuticals up to 1000L.

Many of the countless biopharma freezers don’t meet the requirements of big pharma or small biotech. This comparison of cold storage options will help you make sound decisions for ultracold storage. 

Decontamination by vaporized hydrogen peroxide is common in the pharmaceutical industry. Here, we examine the resistance of RoSS and Bottle RoSS and components against 3% hydrogen peroxide.

Single-use components address long-standing challenges such as sourcing and lead times in the ever-changing and fast-paced pharmaceutical production industry. However, as various players point out, assemblies composed of single-use components that have possibly been sourced from various suppliers may complicate things rather than alleviating them. Suppliers that are willing to adapt to changing needs and come up with new approaches that have what it takes to become established standards of the future are the solution.

The interface between systems and bags or bottles often proves a bottleneck. Learn how to adapt single-use filling assemblies to meet changing needs in the production and filling process.

The Indianapolis-based CDMO has ordered RoSS.FILL CGT to fill lentiviral vectors into small single-use bags. Specially designed for cell and gene therapies, RoSS.FILL CGT is an automated cGMP-compliant filling and filtration platform to dispense small to medium sized volumes of highly valuable drug substances into multiple small single use bags. The technology will be supplied to Genezen’s facility by the end of 2021.

Scalability around freezing means the ability to guarantee constant stress on proteins (biopharmaceutical molecules) in all scales, filling volumes and loading scenarios. Read how by standardizing the IFGS – icefront growth speed – for all possible scenarios regardless of the filling volume and type of bags but also regardless of the type of system, i.e. whether LabScale, MidScale or LargeScale, you can fulil this requirement.

Less than 0,01% of the plastic waste generated annually worldwide are single-use technologies derived from the biopharma. This portion is subject to strict guidelines, so they’re usually collected, decontaminated and disposed rigorously. Furthermore, manufacturers of single-use technologies are obliged to facilitate the separation of the product into its base materials after use. Therefore, the single-use products are mostly very easy to recycle.

The international provider of process solutions for the biopharmaceutical industry, Single Use Support, which was only founded in 2016, is experiencing a massive run on its product innovations.

In an extremely complex, competitive and constantly evolving sector such as the biopharmaceutical industry, flexibility is key, not least since it is an immensely varied and compliance-driven field. This is one of the reasons why more and more logistics solutions – covering all steps from filling to freezing, thawing and distribution – are primarily based on single-use technologies. Read more on you can optimize performance and efficiency with single-use technologies.

In the era of COVID-19 vaccine production levels, the single-use component shortage can paralyze biopharmaceutical production. Manufacturers need to step up and strategize.

A visual comparison of interfacial stress on frozen single use bags: How bags experience stress in plate-based freezers versus conventional static freezers.

SUSupport is a leading provider of safe, reliable and user-friendly solutions when it comes to protected storage and/or shipping of highly sensitive and at the same time highly valuable drug substance contained in single use bags. In addition to their flagship product, the RoSS shell, which protects 2D single-use bags of various sizes, the Austrian solution provider has now developed a stainless-steel 3D bag holder that offers reliable protection for all single use bags of up to 1,000 l.

In order to comply with the versatile requirements of today’s market, flexibility and the option to customize are key whilst maintaining availability and short lead times. This is true for many areas, not least when it comes to the ever-growing number of single-use technologies utilized in the biopharmaceutical industry.

To comply with the versatile requirements of today’s market, flexibility and the option to customize are key whilst maintaining availability and short lead times.

There are many choices for freezing biopharmaceutical bulk material. This paper demonstrates that the initial price can be deceiving and the significant additional costs during ongoing usage. 

CAR-T cell therapy is a promising personalized approach in the treatment of acute or chronic leukemia. Find out more about the CAR therapy and its related chances and risks in this article.

In response to the changing process intensification, development, and production requirements, more labs are choosing an approach based on recyclable and extremely flexible single-use technologies

How biopharma companies are leveraging the speed and flexibility enabled by single use technologies and systems to navigate the maze to a vaccine against COVID-19.

One of the most renowned biopharmaceutical companies in India orders the complete product range of the start-up company Single Use Support based in Austria. The large order associated with this not only opens up the emerging Indian biopharma market, but also underlines the growing relevance of holistic process solutions.

Regardless of all potential pitfalls from the current pandemic Single Use Support has reached the next milestone in its thriving development: The large scale freeze/thaw platform has been commissioned on site in California/US virtually.

Thanks to a cooperation with BakerHicks, Single Use Support is now taking the qualification and validation strategies of mechatronic systems to the next level.

While technically simple to perform, the freeze-storage-thaw cycle comprises several mechanistic aspects that can compromise protein quality if not properly understood and addressed.

There are currently many options of primary packages on how to transport the drug substance from A to B. This paper explains the benefits and shortcomings of a few of those options.

Biopharma manufacturers are increasingly using single use tech for storage, shipping, and transfer of substances. Aabandoning cost-intensive and bulky platforms can save considerable amounts of money.

With bulk drug substances playing an increasingly important role in the industry, the need for a reliable freeze/thaw process as well as safe shipping and storage is more important than ever.

As geographic detachment of biopharmaceutical substance processing from final production becomes standard, freezing biopharmaceutical substances in single use containers offers several advantages.

Parts of a protein solution will show less activity based on the stress it's exposed to during freezing and thawing. It's important to optimize the freezing and thawing process to minimize activity loss.

Did you know that slow freezing kills up to 20% of the protein solutions in biopharmaceutical liquids? This case study shows how fast freezing with a plate freezer reduces the risk of cryoconcentration dramatically.

Protect any single use bag with RoSS: Robust Storage and Shipping. The right material at the right place – what we can learn from oysters.

Flexibility - How to prevent being stuck in one single-use system for biopharmaceuticals.

Liquid bulk drug substance is of utmost value after manufacturing from Biopharma industries. The single use bag independent platform RoSS helps to avoid product loss through breakages through robust composition and makes it possible to introduce your flexible end-to-end solution in drug substance logistics.

Our unrivaled lead times while adjusting to your specifications make it easy to get your customized manifold for filling of drug substance into single use bags and bottles.

We close the gap between downstream and the fill & finish process in the biopharma industry. On the basis of single-use bags, we offer biopharma companies access to a new and almost 100% secure logistics process for liquids.

For any single use bag and any freezing infrastructure freeze your drug substance/product without worries! The right material at the right place – what we can learn from oysters. Tough protected & tamper evident! The tried and tested single-use bag gets its 100% secure and compact shell.

RoSS.pFTU is our “standard" freeze-thaw platform. It is suitable for different batch sizes and offers a fully scalable solution for medium-sized and large batch volumes. The platform is the perfect freeze & thaw single use option as it is compatible with single use bags from all established manufacturers as well as with different sizes and volumes.