Fermentation
Microbial fermentation manufacturing is an effective method for the production of APIs, bioconjugates and smaller biologicals that play an important role in biotechnology and the production of biopharmaceuticals. Manufacturers face different challenges during microbial fermentation. Explore the 7 biggest challenges, followed by the introduction of new solutions.
Daniel Tischler
March 16, 2023
Fermentation
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
Single-use Technology
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.
Claus Exenberger
March 14, 2023
Fermentation
As expert for cold chain handling in bioprocessing, Single Use Support is providing solutions to meet challenges for safe storing and shipping associated with right freezing and thawing methods and temperature control for long-term storage. Their development approach leads to innovative systems that enable manufacturers to replace manual processes with fully automated end-to-end processes that not only push efficiency but also increase output.
Alexander Fuchs
March 14, 2023
End-to-end Solution
When dealing with bulk drug substances, there are several risks to consider along the processing steps. Read more on the critical steps in bulk drug substance production and possible solutions – in this article.
Daniel Tischler
March 13, 2023
Fermentation
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
Freeze & Thaw
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
Freeze & Thaw
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
Single-use Technology
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
Single-use Technology
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
Single-use Technology
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
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
