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Cell & Gene Therapy

CAR-T manufacturing process and the supply chain behind it

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

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

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

RoSS.KSET in Industry 4.0 biomanufacturing

Pharma 4.0

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?

Single-use Consumables

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

Cell & Gene Therapy

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

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.

Michael Mühlegger

March 28, 2022

End-to-end Solution

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

Pharma 4.0

How Pharma 4.0 eliminates human errors in pharmaceutical industry

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.

Michael Mühlegger

March 23, 2022

End-to-end Solution

Scalability of single-use drug substance production

The aim was to achieve a freezing process where the last point of freeze always happens at the same time throughout all scales. If successful, the generated freezing curves will look very similar. Temperature ramps have been used to slow down or accelerate the freezing process.

Michael Eder

March 21, 2022

Pharma 4.0

Pharma 4.0: Pharmaceutical manufacturing on its journey to modernity

Pharma 4.0 is the vision of digitalized pharmaceutical manufacturing. The implementation of modern digital strategies into the production of pharmaceutical goods promises increasing productivity, easier compliance, enhanced connectivity and improved data monitoring to take appropriate action early. Read more!

Michael Eder

March 9, 2022

Single-use tubing assembly - all parts at glance

Single-use Consumables

Single-use tubing assemblies – all parts at a glance

Are you switching your operation to single-use tubing assemblies? In the following, we show you more about the separate components that single-use tubing assemblies and manifolds are made up of and their specific functions.

David Seifert

March 8, 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.

Whitepaper_Controlled_Scalable_Freezing_SEP22

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

1021-Whitepaper_RoSS.FILL_Automated Aseptic Filling_Single Use Support

E-Book

Whitepaper: Automated Aseptic Filling

Automated Aseptic Filling Unprecedented flexibility to filling well