All articles

Single-use Consumables

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!

1640281789974

David Seifert

March 7, 2022

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.

BRMO

Brian Moloney

March 2, 2022

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.

micheal-eder

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.

BRMO

Brian Moloney

February 2, 2022

Pharma 4.0

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. 

micheal-eder

Michael Eder

January 20, 2022

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.

micheal-eder

Michael Eder

January 10, 2022

Single-use Consumables

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!

BRMO

Brian Moloney

January 3, 2022

Single-use Consumables

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.

BRMO

Brian Moloney

December 28, 2021

Single-use Consumables

Medical tubing – Manufacturers, types and materials

An overview of manufacturers and its brands of single-use tubings for biopharmaceutical fluid management.

1640281789974

David Seifert

December 27, 2021

Single-use Consumables

Sterile Connectors for use in Pharma

An overview of manufacturers and its brands of sterile and aseptic connectors for biopharmaceutical fluid management.

BRMO

Brian Moloney

December 27, 2021

Cell & Gene Therapy

Logistic solutions for CAR T-cell therapy - let's scale!

Single Use Support develops scalable solutions and optimizes processes for protecting, fill & freeze, shockfreezing, packaging and handling of small volume cell and gene therapeutics. Learn more about logistics for CAR T-cell therapy!

micheal-eder

Michael Eder

December 22, 2021

Cell & Gene Therapy

Supply chain optimization in cell and gene therapies

Single Use Support is solving problems related to supply chain management through the development of smart packaging and related smart technologies for CAR T-cell therapy. Read more!

BRMO

Brian Moloney

December 20, 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

E-Book

Whitepaper: Automated Aseptic Filling

Automated Aseptic Filling Unprecedented flexibility to filling well