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Primary and secondary packaging of drug substances
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
Solution
Cold chain handling for fermentation: Single-use solutions to lower costs
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
Solution
Safe handling of bulk drug substances
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
Solution
Thawing drug substance: best practices
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
Solution
Freezing drug substance – taking control over large volume pharmaceutical freezing
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
Solution
Meeting cGMP regulations with innovative single-use technologies
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
Solution
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
Solution
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
Solution
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
Solution
Why CDMOs are increasingly using single-use systems
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
Solution
How to choose a CDMO? 7 Considerations to be made
Choosing the right CDMO or CMO to work with is an important decision. Irrespective of which stage biopharma and pharma companies find themselves in, there are certain things to consider that are valid for any stage throughout your production process.
Michael Mühlegger
February 10, 2023
Solution
CDMO in Biopharma: Opportunity or risk?
Both, CDMOs and CMOs, are offering major opportunities in biopharma for startups and emerging companies as well as for established players who are approaching the limits of their manufacturing facilities or are generally looking to outsource parts of or their entire commercial production.
Michael Mühlegger
February 10, 2023
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