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.

The supply chain of single-use assemblies is presently the biggest bottleneck in biopharmaceutical manufacturing. Single Use Support GmbH is taking quick action to alleviate this industry-wide pain by offering single-use manifold assemblies, and – starting today – launching its new online configurator MyManifold.com.

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

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.

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.

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.