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Fermentation

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

Daniel Tischler

March 16, 2023

Single-use Technology

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 - Single Use Support

Claus Exenberger

March 14, 2023

Fermentation

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 | Single Use Support

Alexander Fuchs

March 14, 2023

End-to-end 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

Daniel Tischler

March 13, 2023

Fermentation

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-muehlegger

Michael Mühlegger

March 9, 2023

Freeze & Thaw

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!

micheal-eder

Michael Eder

March 8, 2023

Freeze & Thaw

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 | Single Use Support

Alexander Fuchs

March 7, 2023

Single-use Technology

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-muehlegger

Michael Mühlegger

March 1, 2023

Single-use Technology

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-muehlegger

Michael Mühlegger

March 1, 2023

Single-use Technology

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 - Single Use Support

Claus Exenberger

February 28, 2023

Fermentation

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

Daniel Tischler

February 28, 2023

Fermentation

History of Fermentation: The journey from brewing to advanced therapies

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.

micheal-eder

Michael Eder

February 17, 2023

Recommended Downloads

E-Book

eBook: Filling Gaps in Managing Large Volumes of Biologics

Aseptic aliquotation and cryopreservation of drug substances are crucial process steps in bioprocessing. Even though they’re not in the spotlight of biomanufacturing. In drug development and drug delivery, biologics must be transferred at numerous occasions. Along the journey of monoclonal antibodies, vaccines and more, the drug substance passes lots of process steps where liquid transfer is required. This is relevant for the transitions between upstream processing, downstream processing and fill & finish, but also within these manufacturing milestones. The market of fluid & cold chain management has great growth potential and is on its way to professionalization and industrialization. To meet the challenges of manufacturing drug substances, Single Use Support helps manufacturers and CDMOs to advance their fluid & cold chain management process to achieve a secure and efficient process for liquids on the basis of single-use bags.

E-Book

Whitepaper: How Controlled & Scalable Freezing Becomes Reality

Scalability around freezing means the ability to guarantee constant freezing kinetics on proteins (biopharmaceutical molecules) in all scales, filling volumes and loading scenarios. This guide covers how to achieve scalable freezing & thawing of biopharmaceuticals by showing What is scalability? Setup for controlled icefront growth speed Scalability results Outcomes

E-Book

Whitepaper: Automated Aseptic Filling

Automated Aseptic Filling Unprecedented flexibility to filling well