Biopharma

Single Use Support provides comprehensive insight into the biopharmaceutical industry with a focus on streamlining biopharmaceutical manufacturing. Our integrated end-to-end solutions ensure efficiency and safety from production to patient delivery, as well as reglatory and GMP-compliance. Read about articles that also touch on the role of CDMOs, manufacturing facilities, the path to Pharma 4.0, and many more.

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RoSS.ULTF high density cold storage for laboratory

Biopharma

Start Pharma 4.0: Examples to Advance Ultra-Cold Storage of Drug Substances

Innovative manufacturers are striving for operational excellence in as many areas of bioprocessing as possible. In return,a standardized and fully automated processes contribute to cost efficiency, patient safety, and sustainability in biomanufacturing.

Alexander Fuchs

September 4, 2023

Biopharma

Why CDMOs are increasingly using single-use systems

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.

Michael Mühlegger

February 10, 2023

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All articles about Biopharma

Biopharma

Annex 1: All you need to know

Annex 1 is a fundamental framework for the production of sterile medicinal goods. This article will provide an overview of the concept, its history, contents, challenges, and perspectives.

Michael Mühlegger

March 20, 2024

Biopharma

Top 7 pharmaceutical CDMOs in 2024

Progress in the pharmaceutical industry is significantly driven by CDMOs, collaborating with pharma companies. In this article, we will put 7 outstanding CDMOs in the spotlight.

Michael Mühlegger

March 12, 2024

Biopharma

CMO vs. CDMO: What are the differences?

Both CMOs and CDMOs are frequently relied on partners in the pharmaceutical industry. But what sets them apart, where are their strengths, and what do they offer?

Michael Mühlegger

March 12, 2024

RoSS.FILL Bag_Product Photo_Single Use Support-6

Biopharma

Fluid management in biopharma: Advantages of single-use systems

Major changes in biopharma industry require new approaches along the supply chain of most innovative biologics – including fluid management. Here's to discover how single-use products help to achieve considerable improvements.

Khalil Essani

November 7, 2023

Biopharma

Start Pharma 4.0: Examples to Advance Ultra-Cold Storage of Drug Substances

Alexander Fuchs

September 4, 2023

IRIS Single-Use Assmeblies_Production Kufstein-9

Biopharma

Navigating GMP Annex 1: How Single-Use Assemblies will Comply

GMP Annex 1 significantly impacts the use of single-use assemblies in fluid management processes within the biopharmaceutical industry. It requires manufacturers and stakeholders to adopt a risk-based approach, implement proper controls, and ensure the integrity and sterility of single-use systems.

David Seifert

June 13, 2023

Biopharma

Biopharma supply chain – 7 risks to be aware of

The entire biopharma industry depends on intact supply chain in order to provide patients with the drug products they need. However, there are several factors that can put the integrity of supply chain at risk. In this article, we will discuss seven of them and explore what can be done to circumvent them.

Michael Mühlegger

March 29, 2023

Biopharma

Meeting cGMP regulations with innovative single-use technologies

Manufacturers in the pharmaceutical industry are required to comply with cGMP (Current Good Manufacturing Practice). End-to-end solutions based on automated single-use technologies are an auspicious choice for drug substance manufacturers, given their many advantages. Their implementation in the manufacturing process promises efficiency, high product quality, cost reduction, and energy savings.

Michael Mühlegger

March 1, 2023

Biopharma

cGMP - everything you need to know

The current Good Manufacturing Practice (cGMP) regulations - originated and checked by the FDA - apply to companies operating in pharmaceutical, biotech, or med tech industries. They require the latest standards in terms of production, manufacturing, and packaging and thereby ensure pharmaceutical quality meaning quality in manufacturing processes and patient safety as the ultimate goal. The detailed requirements, importance of cGMP, and how companies can best meet the cGMP regulations, are discussed in the following.

Michael Mühlegger

March 1, 2023

Biopharma

Why CDMOs are increasingly using single-use systems

Michael Mühlegger

February 10, 2023

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

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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: 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.