Manufacturing Processes

Microbial cGMP production: complete guide & manufacturer's overview

Microbial fermentation is a hot topic not only in the biopharma industry. In this article, you will find a brief overview of microbial fermentation manufacturing before we discover different CDMOs offering microbial cGMP production.

Michael Mühlegger

March 9, 2023

Manufacturing Processes

cGMP - everything you need to know

The current Good Manufacturing Practice (cGMP) regulations - originated and checked by the FDA - apply to companies operating in pharmaceutical, biotech, or med tech industries. They require the latest standards in terms of production, manufacturing, and packaging and thereby ensure pharmaceutical quality meaning quality in manufacturing processes and patient safety as the ultimate goal. The detailed requirements, importance of cGMP, and how companies can best meet the cGMP regulations, are discussed in the following.

Michael Mühlegger

March 1, 2023

Manufacturing Processes

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.

Claus Exenberger

February 28, 2023

Manufacturing Processes

Reducing product loss & human error in pharmaceutical fermentation

Pharmaceutical manufacturing processes, including pharmaceutical fermentation, are still prone to human error and product loss. The challenges can be overcome by moving to automated processes that eliminate the need for slow and error-prone manual handling. Adopting automated end-to-end solutions based on single-use technologies minimizes, if not eliminates, human error and product loss.

Daniel Tischler

February 28, 2023

Manufacturing Processes

Fermentation in the pharmaceutical industry: A complete guide

Fermentation in the pharmaceutical industry is used to cultivate microorganisms for antibiotics, therapeutic proteins, enzymes and insulin. It typically involves temperature-controlled tanks, also known as fermenters and the correct concentration of nutrients to cultivate the desired organism. Microbial and bacterial fermentation technology and the associated processes open new possibilities and are important building blocks for gene-editing, conjugates and DNA plasmids used in modern vaccine production.

Daniel Tischler

February 17, 2023

Manufacturing Processes

Precision Fermentation simply explained

Precision fermentation uses microbial hosts to produce a particular end product. Other terms used for precision fermentation are bacterial and microbial fermentation. 

Precision fermentation is used in a variety of ways in both the food industry and pharmaceutical industry to produce biopharmaceuticals. Read more!

Michael Eder

February 14, 2023

Manufacturing Processes

Microbial Fermentation simply explained

Microbial fermentation is a biochemical process that manages to extract chemical energy from carbohydrates without the oxygen. 

This chemical reaction occurs in bacteria, yeasts or even in muscles of humans. Read more details!

Michael Eder

February 14, 2023

Manufacturing Processes

Differences between microbial fermentation & mammalian cell culture

Microbial fermentation in bacteria, yeast or fungi is, due to its benefits, preferred in the production of smaller biologics. These include peptides, proteins, cytokines, growth factors, plasmid DNA, single-domain antibodies, peptibodies and more. Continue reading...!

Daniel Tischler

February 14, 2023

Manufacturing Processes

Best choice for cold storage of Biopharmaceuticals - A Comparison

What's the best choice for long-term cold storage of valuable drug substance? Comparing different Biopharma technologies.

Alexander Fuchs

January 3, 2023

Manufacturing Processes

Single-Use Technologies: Scalable, Modular Systems Bring Cost Efficiency to Bioprocessing

Ebook published at GEN News (Genetic Engineering & Biotechnology News): The evolution of single-use technologies (SUTs) is among the most important developments of biomanufacturing. There has been a shift toward SUT, which has enhanced manufacturing agility and flexibility greatly.

Michael Eder

December 22, 2022

Manufacturing Processes

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.

Daniel Tischler

December 20, 2022

Manufacturing Processes

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. 

Daniel Tischler

December 19, 2022