All articles about Biopharma

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-muehlegger

Michael Mühlegger

May 18, 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.

micheal-eder

Michael Eder

March 24, 2022

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-muehlegger

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.

micheal-eder

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!

micheal-eder

Michael Eder

March 9, 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. 

micheal-eder

Michael Eder

January 20, 2022

Biopharma

Enabling end-to-end process solutions for bottles

The Single Use Support end-to-end process for bottles can be applied independently from bottle manufacturer, it is modular and can be topped off with services such as qualifications, after-sales service and biopharma know-how.

Ramona Hintner

October 21, 2021

Biopharma

Single-use end-to-end solutions - flexible, scalable and reliable

In an extremely complex, competitive and constantly evolving sector such as the biopharmaceutical industry, flexibility is key, not least since it is an immensely varied and compliance-driven field. Learn more in this article!

micheal-eder

Michael Eder

June 2, 2021

Biopharma

The call for industrial end-to-end solutions in Biopharma has been heard

Irrespective of what industry we are talking about, the term end-to-end solution describes a principle that takes a system or service – from beginning to end – and delivers a complete functional solution.
 

micheal-eder

Michael Eder

September 28, 2020

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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: Robust Storage & Shipping - The secondary packaging for every single-use bag

The RoSS® shell offers a robust & safe protection for bioprocess containers of any size and vendor during freezing, transportration, storage & thawing. With more than 300,000+ RoSS® shells sold worldwide, the RoSS® shell provides a tamper-evident, contamination-free system. The perfect composition for robust storage & shipping for all 2D single-use bags. The RoSS® shell's composition of elements that embed the bioprocess containers is simple, easy to recycle, validated for use in cleanroom environment, and it offers significant cost-efficiencyand process flexibility. It provides validated robustness, ensures immbolization and enables plate freezing, leading to numerous advantages in biopharmaceutical manufacturing.

E-Book

Case Study: Single-use assembly capabilities to keep pace with biopharma dynamics

Single Use Support has a proven track record to provide sterile single-use assemblies to many biopharmaceutical companies in different scenarios: - Production of thousands of single-use manifolds weekly as a workbench solution during pandemic-driven unavailabilites of single-use components - Pandemic preparedness campaigns to stock diverse manifolds for future unexpected events - Ramping up complexity and quantity of single-use assemblies for vaccine production from clinical phase to commercial production throughout a product's lifecycle.