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Human error pharmaceutical industry Pharma 4.0

Biopharma

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

Biopharma

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

Biopharma

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

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

Single-Use-Support-Controlled-Freezing-Biopharmaceuticals

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

Bioprocessing

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

Biopharma

At the forefront of Pharma 4.0

There is no full Pharma 4.0 manufacturing in place yet, but there are first innovations to build on.
Currently numerous manual handling steps in biopharmaceutical manufacturing come along with a high degree of failures in manufacturing facilities deriving from human errors in operative handling.

Michael Eder

January 20, 2022

Safety and speed are tow major factors in CAR T cell therapy

Cell & Gene Therapy

Safety & Speed: handling two major factors in CAR T-cell therapy

In order to allow for a smooth and functioning process, a reliable supply chain, tailored to the specific needs of autologous therapies, is a prerequisite. Single Use Support has developed an end-to-end process solution for cell and gene therapies.

Michael Eder

January 10, 2022

How to safely connect single-use tubings

Fill & Filtration

How to safely connect a single-use tubing set?

When safety, time and flexibility are of the essence, the solution should be an easy one. This is why the team at MyManifold have come up with an intuitive, easy-to-use configurator for sterile filling systems. Users can design their own assembly prototype. Read how!

Brian Moloney

January 3, 2022

RoSS.FILL Bag_Product Photo_With Filter_Single Use Support-2 (1)

Fill & Filtration

Sterile medical filters – Overview of the most reliable producers and their products

An overview of manufacturers and its brands of sterile medical membrane filters for biopharmaceutical fluid management.

Brian Moloney

December 28, 2021

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.

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.