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Biopharma

How to choose a CDMO? 7 Considerations to be made

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.

Michael Mühlegger

February 10, 2023

Biopharma

CDMO in Biopharma: Opportunity or risk?

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.

Michael Mühlegger

February 10, 2023

RoSS.ULTF_Cold Storage of Biopharmaceuticals

Freeze & Thaw

Best choice for cold storage of Biopharmaceuticals - A Comparison

What's the best choice for long-term cold storage of valuable drug substance? Comparing different Biopharma technologies.

Alexander Fuchs

January 3, 2023

Single-use Technology

Single-Use Technologies: Scalable, Modular Systems Bring Cost Efficiency to Bioprocessing

Ebook published at GEN News (Genetic Engineering & Biotechnology News): The evolution of single-use technologies (SUTs) is among the most important developments of biomanufacturing. There has been a shift toward SUT, which has enhanced manufacturing agility and flexibility greatly.

Michael Eder

December 22, 2022

Bioprocessing

Upstream processing with single-use systems

The manufacturing process of biopharmaceuticals such as monoclonal antibodies, mRNA and bioconjugates is divided into upstream and downstream processing. Manufacturers seeking reliable automation and optimization fit for scale-up are increasingly employing single-use bioreactors, titers, filtration and other components, especially during upstream.

Daniel Tischler

December 20, 2022

Single-use technology in downstream processing

Bioprocessing

Downstream processing with single-use systems

One would think that a sector like the fast-paced biomanufacturing industry could not get any faster. Yet, increased speed-to-market and ever more efficient manufacturing continue to drive product and process development. This is why single-use technologies have become increasingly popular. Read more about single-use systems for downstream processing in this article.

Daniel Tischler

December 19, 2022

Bioprocessing

What is upstream and downstream processing?

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

Daniel Tischler

December 19, 2022

Freeze & Thaw

How Hybrid Freeze-Thaw Platforms Defy Cryoconcentration

Freezing and Thawing drug substances in both primary packagings, single-use bags and bottles, in one platform is possible with hybrid freezers. Biopharmaceutical manufacturers and CMOs face challenges to prevent the effect of cryoconcentration during freezing, leading to loss of product quality. Tests have shown that hybrid freezer defy cryoconcentration with homogeneous freezing of both single-use bags and bottles.

Daniel Tischler

December 7, 2022

controlling-cryogenic-freezing-liquid-nitrogen

Freeze & Thaw

Controlling cryogenic freezing with liquid nitrogen

To control cryogenic freezing is not an easy task, especially when liquid nitrogen is involved. To keep small molecules chemically stable and prevent chemical degradation, the right practices have to be in place. Find out everything about controlled cryogenic freezing with LN2 in this article!

Daniel Tischler

November 8, 2022

Bioconjugates

ADC companies: Big players working with antibody drug conjugates

The antibody-drug conjugates (ADCs) market is expected to grow significantly in the next few years. But what are the key players in this competitive landscape? Find out more in this article!

Michael Eder

November 7, 2022

Bioconjugates

Controlled freezing of ADCs

Antibody-drug conjugates might revolutionize the treatment of cancer and various other diseases. However, there are some challenges to overcome in their handling, including controlled freezing – find out more in this article!

Johannes Kirchmair

October 13, 2022

Frozen single use bag in RoSS shell single use bag protection

Sustainability

Mission completed – and now? How RoSS® Shell is to be recycled

Once they have fulfilled their purpose to protect valuable biologics, the question for our RoSS containers arises: What now? This is why we summarized information on the recycling of our containers for single use bags in this article.

Claus Exenberger

October 12, 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.