All articles about Manufacturing Processes
Manufacturing Processes
Plate freezing: best approach for freezing biopharmaceuticals
Plate freezing is a process where a product’s temperature is reduced by the means of contact with cold surfaces. Thus, a defining step in the freeze-thaw process for conservation, with several advantages for biopharma.
Alexander Fuchs
May 18, 2022
Manufacturing Processes
Industry 4.0 in Biomanufacturing: RoSS.KSET as an example
Industry 4.0 has long become reality in many branches. In Pharma 4.0 intelligent industrial applications and IoT enable players in the bioeconomy industry to transition to operations that help them improve their productivity. Pharma 4.0 also has become a major part in single-use technologies, as it brings companies to the next level concerning the scalability, productivity and efficiency of their processes and products.
Michael Mühlegger
May 18, 2022
Manufacturing Processes
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.
David Seifert
April 12, 2022
Manufacturing Processes
Storage Density in Biopharma Manufacturing Facilities
Single-use bags with its flat shape is predestined for stacking and offer great solutions to increase storage density on-site but also for shipment. The combination of both, single use bag and RoSS® shells (Robust Storage and Shipping) makes them a cost-effective solution, as they require little storage space. RoSS® shells are available for all sizes and suppliers of single-use bags.
Michael Eder
March 24, 2022
Manufacturing Processes
How Pharma 4.0 eliminates human errors in pharmaceutical industry
Pharma 4.0 aims at improving risk management. It aims at updating the pharmaceutical industry and ensuring data integrity by incorporating advanced digital formats and enablers into the current Pharmaceutical Quality System (ICH Q10). The final goal is to minimize, if not eradicate, human error.
Michael Mühlegger
March 23, 2022
Manufacturing Processes
Scalability of single-use drug substance production
The aim was to achieve a freezing process where the last point of freeze always happens at the same time throughout all scales. If successful, the generated freezing curves will look very similar. Temperature ramps have been used to slow down or accelerate the freezing process.
Michael Eder
March 21, 2022
Manufacturing Processes
Pharma 4.0: Pharmaceutical manufacturing on its journey to modernity
Pharma 4.0 is the vision of digitalized pharmaceutical manufacturing. The implementation of modern digital strategies into the production of pharmaceutical goods promises increasing productivity, easier compliance, enhanced connectivity and improved data monitoring to take appropriate action early. Read more!
Michael Eder
March 9, 2022
Manufacturing Processes
Single-use tubing assemblies – all parts at a glance
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.
David Seifert
March 8, 2022
Manufacturing Processes
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!
David Seifert
March 7, 2022
Manufacturing Processes
Aseptic bag filling – 5 critical considerations
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.
Brian Moloney
March 2, 2022
Manufacturing Processes
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.
Michael Eder
February 15, 2022
Manufacturing Processes
Inline buffer dilution: an agile system for downstream processes
Inline buffer dilution (IBD) is a method for on demand buffer preparation from buffer concentrates at the point of use. This article will give an overview of the inline buffer dilution process and discuss its benefits over the traditional formulation of buffer solutions.
Brian Moloney
February 2, 2022
Discover more topics
Articles by Biopharmaceutical Products:
Articles by Manufacturing Processes: