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Freeze & Thaw

Pharmaceutical cold storage – overview of all freezing ranges

Temperature plays a significant role in the production and distribution of several revolutionary biologics. But how does the pharmaceutical cold chain work, and what temperature ranges are most frequently chosen? You will find out in this article!

Alexander Fuchs

July 25, 2022

Freeze & Thaw

Ultra-cold freezing and storing – considerations & solutions

Implementing cold freezing and storing in supply chains is oftentimes inevitable when dealing with certain biopharmaceuticals. Learn what the main considerations are and find out how to face related challenges.

Daniel Tischler

July 19, 2022

Car-t manufacturing process and the supply chain behind it

Cell & Gene Therapy

CAR-T manufacturing: process and supply chain strategies

Mastering the complex CAR T manufacturing process and the associated supply chain challenges in the cell and gene area are the major bottlenecks during the large-scale commercialization of highly promising CAR T cell products.

Michael Eder

June 23, 2022

Single-use Technology

Case Study: Reducing product loss | Bag-independence

Learn about the benefits of supplier-agnostic solutions around single-use bioprocess containers that help minimize product loss.

Claus Exenberger

June 20, 2022

Nucleic Acids

mRNA vaccines: How to safely ship and store them

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.

Daniel Tischler

June 9, 2022

Cell & Gene Therapy

Gene therapy manufacturing - 5 requirements to scale up

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.

Michael Mühlegger

June 9, 2022

Single-use Technology

Case Study: Reducing product loss | Cost-efficiency

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!

Claus Exenberger

June 8, 2022

Plate freezer large scale with RoSS shells

Freeze & Thaw

Plate freezing: best approach for freezing biopharmaceuticals

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.

Alexander Fuchs

May 18, 2022

Cell & Gene Therapy

Autologous vs. Allogeneic Cell Therapy

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.

Brian Moloney

May 18, 2022

RoSS.KSET in Industry 4.0 biomanufacturing

Biopharma

Industry 4.0 in Biomanufacturing: RoSS.KSET as an example

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.

Michael Mühlegger

May 18, 2022

Extractables and leachables - what is the difference?

Fill & Filtration

Extractables and leachables: definitions, differences & facts

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.

David Seifert

April 12, 2022

Biopharma

Storage Density in Biopharma Manufacturing Facilities

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.

Michael Eder

March 24, 2022

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.

Single-Use-Support-Controlled-Freezing-Biopharmaceuticals

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

aav-production-efficiency-improvements-single-use-technology

E-Book

Whitepaper: Automated Aseptic Filling

Read our Whitepaper about Automated Aseptic Filling in Pharmaceutical Manufacturing | Discover why automatic filling solutions are preferable to manual filling.