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Solution
Evolving Methods of Bulk Freezing
New technologies, sauch as plate-based freezing and thawing based on single-use systems, improve process efficiency and product quality. Innovative solutions are breaking the ice for the evolution of bulk drug freezing.
Michael Eder
June 23, 2023
Solution
Navigating GMP Annex 1: How Single-Use Assemblies will Comply
GMP Annex 1 significantly impacts the use of single-use assemblies in fluid management processes within the biopharmaceutical industry. It requires manufacturers and stakeholders to adopt a risk-based approach, implement proper controls, and ensure the integrity and sterility of single-use systems.
David Seifert
June 13, 2023
Solution
Automated bioprocessing – 7 advantages of automation
Automation is affecting various aspects of our lives, including bioprocessing. In this article, we will explore the advantages that come with this development.
Michael Mühlegger
April 12, 2023
Solution
Dry to Die: How Spray Drying can be Replaced by Freezing in the Production of Bulk Intermediates
Spray drying often leads to product losses of mAbs or vaccines of more than 30%. Plate-based freezing and thawing solutions enable controlled handling of bulk intermediates safely in a vendor-independent, modular and scalable fluid and cold chain management process.
Daniel Tischler
April 12, 2023
Solution
Drug substance vs. drug product – these are the differences
The terms "drug substance" and "drug product" are often used synonymously, although there are some fundamental differences between them. We will point them out in the course of this article!
Michael Eder
April 11, 2023
Solution
Bioprocessing – everything you need to know
Bioprocessing is a fundamental technology for various aspects of our lives, including the biopharma industry. In this article, we will provide some interesting facts about applications, techniques and future expectations regarding bioprocessing.
Khalil Essani
April 6, 2023
Solution
Biopharma supply chain – 7 risks to be aware of
The entire biopharma industry depends on intact supply chain in order to provide patients with the drug products they need. However, there are several factors that can put the integrity of supply chain at risk. In this article, we will discuss seven of them and explore what can be done to circumvent them.
Michael Mühlegger
March 29, 2023
Solution
Bulk drug substance management
The following article aims to take a closer look at the term “bulk drug substance” and its meaning, as well as to investigate smart solutions to shorten the phase between development and blockbuster production. Read more about the solution for the biopharmaceutical industry!
Michael Eder
March 22, 2023
Solution
Filling of drug substance: 5 threats you should know
When it comes to the filling process of drug substances, there several aspects to be considered to achieve high-quality results with as little product loss as possible. In this article, we will discuss 5 major threats for the filling of drug substances.
Michael Eder
March 20, 2023
Solution
Microbial Fermentation Manufacturing: Advances through single-use technologies
Microbial fermentation is a powerful, flexible microbiology process used to generate microbial cells or biomass such as proteins and enzymes for the production of vaccines and therapeutics. There are still some challenges to overcome. Many of these challenges in fermentation manufacturing can be solved by replacing traditional systems with single-use technologies.
Daniel Tischler
March 17, 2023
Solution
Biopharma packaging - requirements and solutions
In this article, we will discuss the special requirements of biologicals in terms of packaging as well as efficiency and sustainability aspects of biopharma packaging.
Michael Eder
March 16, 2023
Solution
Filling & Freezing large volumes for fermentation in less than 8 hours
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.
Daniel Tischler
March 16, 2023
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