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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

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

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

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

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

Single-use tubing assembly - all parts at glance

Fill & Filtration

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

PUPSIT - pre-use post sterilization integrity testing

Fill & Filtration

PUPSIT - An Introduction to Pre-use Post Sterilization Integrity Testing

PUPSIT will contribute to simplifying not only integrity testing and validation but manufacturing processes in general, while keeping in line with current good manufacturing processes and any standards and guidelines defined by major authorities such as FDA and EMA. Read all about it!

David Seifert

March 7, 2022

Critical considerations of aseptic single use bag filling

Fill & Filtration

Aseptic bag filling – 5 critical considerations

Aseptic bag filling is a process that is very important to the biopharma industry. This article will give you the basics of aseptic bag filling, highlight the most critical factors of the technique and discuss key considerations pertaining to the commercial use of aseptic bags.

Brian Moloney

March 2, 2022

Whitepaper_Controlled_Scalable_Freezing_SEP22

Freeze & Thaw

Whitepaper: How controlled freezing enables scalability

In a comprehensive study the impact of ice front growth speed on scalability of freezing protein solutions has been evaluated.

Michael Eder

February 15, 2022

End-to-end Solution.

Inline buffer dilution: an agile system for downstream processes

Inline buffer dilution (IBD) is a method for on demand buffer preparation from buffer concentrates at the point of use. This article will give an overview of the inline buffer dilution process and discuss its benefits over the traditional formulation of buffer solutions.

Brian Moloney

February 2, 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.