Single-use technology

March 20, 2023

Filling of drug substance: 5 threats you should know

micheal-eder
Michael Eder

When it comes to the filling process of drug substances, there several aspects to be considered to achieve high-quality results with as little product loss as possible. In this article, we will discuss 5 major threats for the filling of drug substances.

March 17, 2023

Microbial Fermentation Manufacturing: Advances through single-use technologies

daniel-tischler
Daniel Tischler

Microbial fermentation is a powerful, flexible microbiology process used to generate microbial cells or biomass such as proteins and enzymes for the production of vaccines and therapeutics. There are still some challenges to overcome. Many of these challenges in fermentation manufacturing can be solved by replacing traditional systems with single-use technologies. 

March 16, 2023

Biopharma packaging - requirements and solutions

micheal-eder
Michael Eder

In this article, we will discuss the special requirements of biologicals in terms of packaging as well as efficiency and sustainability aspects of biopharma packaging.

March 14, 2023

Primary and secondary packaging of drug substances

micheal-eder
Michael Eder

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. 

March 14, 2023

Cold chain handling for fermentation: Single-use solutions to lower costs

mike-marciniak
Mike Marciniak

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.

March 6, 2023

Biopharmaceutical processing – how disposable solutions increase safety and efficiency

mike-marciniak
Mike Marciniak

Biopharmaceutical processing is indispensable across various fields of medicine and life sciences. In this article, we will discover how single-use solutions can increase efficiency and safety in biopharmaceutical processing.

March 1, 2023

Meeting cGMP regulations with innovative single-use technologies

michael-muehlegger
Michael Mühlegger

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.

March 1, 2023

cGMP - everything you need to know

michael-muehlegger
Michael Mühlegger

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.

February 28, 2023

Shipping pharmaceutical liquids and its challenges

daniel-tischler
Daniel Tischler

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.

February 10, 2023

Why CDMOs are increasingly using single-use systems

michael-muehlegger
Michael Mühlegger

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. 

February 10, 2023

How to choose a CDMO? 7 Considerations to be made

michael-muehlegger
Michael Mühlegger

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.

February 10, 2023

CDMO in Biopharma: Opportunity or risk?

michael-muehlegger
Michael Mühlegger

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.