End-to-end solution

February 10, 2023

Why CDMOs are increasingly using single-use systems

michael-muehlegger
Michael Mühlegger

By combining a number of benefits, single-use technologies that are compliant with cGMP and GAMP seem the perfect choice. For manufacturers of drug substances, they provide a more efficient, cost-effective, and scalable solution than stainless-steel tanks by offering. 

February 10, 2023

How to choose a CDMO? 7 Considerations to be made

michael-muehlegger
Michael Mühlegger

Choosing the right CDMO or CMO to work with is an important decision. Irrespective of which stage biopharma and pharma companies find themselves in, there are certain things to consider that are valid for any stage throughout your production process.

February 10, 2023

CDMO in Biopharma: Opportunity or risk?

michael-muehlegger
Michael Mühlegger

Both, CDMOs and CMOs, are offering major opportunities in biopharma for startups and emerging companies as well as for established players who are approaching the limits of their manufacturing facilities or are generally looking to outsource parts of or their entire commercial production. 

December 19, 2022

What is upstream and downstream processing?

bernhard-schlichtner
Bernhard Schlichtner

Upstream and downstream processing are two steps inherent to the production of active pharmaceutical ingredients (API) used in biopharmaceuticals. The production is challenged by increasing regulation and manufacturing costs. This calls for flexible solutions, which is why a growing number of manufacturing processes utilize single-use systems

March 24, 2022

Storage Density in Biopharma Manufacturing Facilities

micheal-eder
Michael Eder

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.

March 21, 2022

Scalability of single-use drug substance production

micheal-eder
Michael Eder

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.

February 15, 2022

Whitepaper: How controlled freezing enables scalability

micheal-eder
Michael Eder

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

February 2, 2022

Inline buffer dilution: an agile system for downstream processes

BRMO
Brian Moloney

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.

October 21, 2021

Enabling end-to-end process solutions for bottles

Ramona Hintner

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.

August 30, 2021

Does RoSS® resist vaporized hydrogen peroxide?

elisabeth-haas-karagiannidis
Elisabeth Haas-Karagiannidis

Infiltrating product solutions from life science companies or any other supplier into Biopharma environment is justifiably not so simple. RoSS has undergone tests to find out whether the treatment of H2O2 has any effect on the surface of all its components. 

June 2, 2021

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

micheal-eder
Michael Eder

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!

September 28, 2020

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

micheal-eder
Michael Eder

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.