March 14, 2023
Primary and secondary packaging of drug substances
Throughout the manufacturing process of drug substances, the liquids must be transferred frequently, such as during the upstream and downstream processing. Safe packaging of large volume substances is of high necessity in each step. Protection is ensured by appropriate primary and secondary packaging. This article will provide an overview of the different types of primary and secondary packaging materials, which are used specifically for safe handling of drug substance.
February 28, 2023
Shipping pharmaceutical liquids and its challenges
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.
December 20, 2022
Upstream processing with single-use systems
The manufacturing process of biopharmaceuticals such as monoclonal antibodies, mRNA and bioconjugates is divided into upstream and downstream processing. Manufacturers seeking reliable automation and optimization fit for scale-up are increasingly employing single-use bioreactors, titers, filtration and other components, especially during upstream.
December 19, 2022
Downstream processing with single-use systems
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.
October 12, 2022
Mission completed – and now? How RoSS® Shell is to be recycled
Once they have fulfilled their purpose to protect valuable biologics, the question for our RoSS containers arises: What now? This is why we summarized information on the recycling of our containers for single use bags in this article.
April 12, 2022
Extractables and leachables: definitions, differences & facts
Extractables and leachables are contaminants that are causing biopharmaceutical manufacturers headaches, as they can lead to impurities of highly valuable drug products. While extractables and leachables both describe foreign matter that can lead to contamination of highly valuable drug products, it is important to understand their characterization but also the difference between the two.
March 8, 2022
All parts at a glance of Single-use tubing assemblies
Are you switching your operation to single-use tubing assemblies? In the following, we show you more about the separate components that single-use tubing assemblies and manifolds are made up of and their specific functions.
March 7, 2022
PUPSIT - An Introduction to Pre-use Post Sterilization Integrity Testing
PUPSIT will contribute to simplifying not only integrity testing and validation but manufacturing processes in general, while keeping in line with current good manufacturing processes and any standards and guidelines defined by major authorities such as FDA and EMA. Read all about it!
March 2, 2022
5 critical considerations for aseptic bag filling
Aseptic bag filling is a process that is very important to the biopharma industry. This article will give you the basics of aseptic bag filling, highlight the most critical factors of the technique and discuss key considerations pertaining to the commercial use of aseptic bags.
February 15, 2022
Whitepaper: How controlled freezing enables scalability
In a comprehensive study the impact of ice front growth speed on scalability of freezing protein solutions has been evaluated.
January 3, 2022
How to safely connect single-use tubings?
When safety, time and flexibility are of the essence, the solution should be an easy one. This is why the team at MyManifold have come up with an intuitive, easy-to-use configurator for sterile filling systems. Users can design their own assembly prototype. Read how!
December 28, 2021
Sterile medical filters – Overview of the most reliable producers and their products
An overview of manufacturers and its brands of sterile medical membrane filters for biopharmaceutical fluid management.