News

June 9, 2022

mRNA vaccines: How to safely ship and store them

daniel-tischler
Daniel Tischler

mRNA vaccines require high diligency along their supply chain. This is why every step in the mRNA vaccine supply chain must be carefully planned, carried out in a safe and controlled manner and requires appropriate, innovative technologies.

June 9, 2022

Gene therapy manufacturing - 5 requirements to scale up

michael-muehlegger
Michael Mühlegger

Gene therapies have become a highly promising field of groundbreaking next generation treatment, but there are some challenges to face within the manufacturing process. Here are 5 factors that will be crucial for upscaling gene therapy manufacturing with single-use technology.

June 8, 2022

Case Study: Reducing product loss | Cost-efficiency

MIWI
Michael Wieland

It is the key issue in the management of bulk medicines: How can product loss be avoided or at least reduced? This article explains everything about this topic!

May 18, 2022

Plate freezing: best approach for freezing biopharmaceuticals

daniel-tischler
Daniel Tischler

Plate freezing is a process where a product’s temperature is reduced by the means of contact with cold surfaces. Thus, a defining step in the freeze-thaw process for conservation, with several advantages for biopharma.

May 18, 2022

Autologous vs allogeneic cell therapy

barbara-m-fischer
Barbara M. Fischer

Although autologous and allogeneic cell therapies share both defining methodological key elements as well as various fields of application, including most innovative cancer therapies, there are significant differences between them. Therefore, a closer look on both procedures shall be presented.

May 18, 2022

Industry 4.0 in Biomanufacturing: RoSS.KSET as an example

michael-muehlegger
Michael Mühlegger

Industry 4.0 has long become reality in many branches. In Pharma 4.0 intelligent industrial applications and IoT enable players in the bioeconomy industry  to transition to operations that help them improve their productivity. Pharma 4.0 also has become a major part in single-use technologies, as it brings companies to the next level concerning the scalability, productivity and efficiency of their processes and products. 

April 12, 2022

Extractables and leachables: definitions, differences & facts

lorenzo-de-benedictis
Lorenzo De Benedictis

Extractables and leachables are contaminants that are causing biopharmaceutical manufacturers headaches, as they can lead to impurities of highly valuable drug products. While extractables and leachables both describe foreign matter that can lead to contamination of highly valuable drug products, it is important to understand their characterization but also the difference between the two.

March 29, 2022

Supply Chain Delays in the Biopharma industry

micheal-eder
Michael Eder

Global supply chains have been severely impacted by the pandemic and by attempts to maintain essential supply structures such as food, medicine, and energy supplies.

March 28, 2022

Costs for CAR T-cell therapy - How to deploy cost-efficiency

michael-muehlegger
Michael Mühlegger

CAR T-cell treatments are deservedly on the rise, as the effectiveness of CAR T-cell products for formerly hard to treat hematology malignancies has been established in clinical trials. This article will highlight one of the less discussed issues of immunotherapy in cancer treatment: it’s current price tag could hamper the broad accessibility to patients.

March 24, 2022

Avoiding product loss with single-use systems

micheal-eder
Michael Eder

With the RoSS® shell (Robust Storage and Shipping) the single use bag is covered by soft 3D foam, which provides a protective embedding of the single use bag and absorbs the expanding energy of the bag/liquid of about 8% due to the density drop during freezing.

March 24, 2022

Storage Density in Biopharma Manufacturing Facilities

micheal-eder
Michael Eder

Single-use bags with its flat shape is predestined for stacking and offer great solutions to increase storage density on-site but also for shipment. The combination of both, single use bag and RoSS® shells (Robust Storage and Shipping) makes them a cost-effective solution, as they require little storage space. RoSS® shells are available for all sizes and suppliers of single-use bags.

March 23, 2022

How Pharma 4.0 eliminates human errors in pharmaceutical industry

michael-muehlegger
Michael Mühlegger

Pharma 4.0 aims at improving risk management. It aims at updating the pharmaceutical industry and ensuring data integrity by incorporating advanced digital formats and enablers into the current Pharmaceutical Quality System (ICH Q10). The final goal is to minimize, if not eradicate, human error.