Vaccines
For drug substances that undergo a freezing process during manufacturing, thawing at some point is only a logical consequence. However, there are several factors to be considered for this seemingly easy procedure – find out more in this article!
Michael Eder
March 8, 2023
Vaccines
Freezing large volumes of drug substance can be a challenging endeavor. In this article, we will discuss main considerations as well as possible solutions for this delicate process.
Alexander Fuchs
March 7, 2023
Biopharma
Manufacturers in the pharmaceutical industry are required to comply with cGMP (Current Good Manufacturing Practice). End-to-end solutions based on automated single-use technologies are an auspicious choice for drug substance manufacturers, given their many advantages. Their implementation in the manufacturing process promises efficiency, high product quality, cost reduction, and energy savings.
Michael Mühlegger
March 1, 2023
Biopharma
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
Freeze & Thaw
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
Bioprocessing
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
Bioprocessing
Fermentation has been with mankind at least since the first settlements in the Middle East about 12,000 years ago. Today, scientists have gained so much knowledge about microorganisms and the fermentation process that pharmaceutical manufacturers are using it for the production of vaccines or bioconjugates like ADCs (antibody-drug conjugates) and the development of advanced therapies.
Michael Eder
February 17, 2023
Bioprocessing
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
Bioprocessing
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
Bioprocessing
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
Bioprocessing
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
Biopharma
By combining a number of benefits, single-use technologies that are compliant with cGMP and GAMP seem the perfect choice. For manufacturers of drug substances, they provide a more efficient, cost-effective, and scalable solution than stainless-steel tanks by offering.
Michael Mühlegger
February 10, 2023
