All articles

Vaccines

Biologics vs. Biosimilars: What is the difference?

Biologics and biosimilars are both innovative and frequently used therapeutics, but where do they differ? They will be uncovered in this article.

micheal-eder

Michael Eder

May 6, 2024

Vaccines

Freezing biologics – best practices

There is more than one way to prepare biologics for long-term storage under temperature-controlled conditions – in this article, we will explore some of the main freezing methods.

Alexander Fuchs | Single Use Support

Alexander Fuchs

May 6, 2024

Bioconjugates

ADC manufacturing: Process, Challenges & Solutions

Scale-up and industrial production of ADCs face complications due to the high safety measures which need to be taken to guarantee product efficacy and a protected working environment for staff and manufacturers. In this article we seek out to give you an overview of the different challenges during ADC manufacturing while also introducing solutions which help to ensure aseptic production methods through single-use-technologies and end-to-end systems. 

BRMO

Brian Moloney

May 5, 2024

End-to-end Solution

An introduction to therapeutic proteins

Therapeutic proteins hold promise in the treatment of numerous medical conditions, and progress in this field is far from being over. This is reason enough to take a general look at this class of therapeutics.

Alexander Fuchs | Single Use Support

Alexander Fuchs

April 10, 2024

End-to-end Solution

Protein storage: How to increase protein stability?

Prior to be used in diagnostics or therapeutics, proteins have to be safely stored. In this article, we will assess methods to preserve their stability upon storage.

Alexander Fuchs | Single Use Support

Alexander Fuchs

April 10, 2024

End-to-end Solution

Protein production and optimization strategies

Protein production is a crucial process that which a large variety of pharmaceutical products rely on. Therefore, we will discuss this procedure in this article, along with possibilities to improve it.


 

Khalil Essani - Single Use Support

Khalil Essani

April 9, 2024

End-to-end Solution

Protein stability – all you need to know

Protein stability is crucial to be maintained along the manufacturing process of protein-based products. In this article, we will discover what influences protein stability, along with methods to assess and increase it.

Khalil Essani - Single Use Support

Khalil Essani

April 9, 2024

Vaccines

What are Active Pharmaceutical Ingredients (APIs)?

Active Pharmaceutical Ingredients (APIs) are the cornerstone of pharmaceutical drugs, serving as the primary agents responsible for delivering therapeutic effects to patients. 

micheal-eder

Michael Eder

March 21, 2024

Freeze & Thaw

Cold Storage Requirements for Active Pharmaceutical Ingredients

Active pharmaceutical ingredients (APIs) are fundamental for drug products to be effective, but require special treatment – e.g. considering humidity, light, or temperature. In this article, we will highlight the different cold storage requirements of APIs, including examples and an overview of different practical approaches.

Alexander Fuchs | Single Use Support

Alexander Fuchs

March 21, 2024

Single-use Consumables

Bubble point test: Purpose & Procedure

Among the possible filter integrity testing methods, the bubble point test belongs to the most frequent ones. Therefore, this article will describe the process along with its applications, benefits and limitations, and its automation.

1640281789974

David Seifert

March 20, 2024

Single-use Consumables

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-muehlegger

Michael Mühlegger

March 20, 2024

Single-use Consumables

Annex 1 and the PUPSIT requirement

Annex 1 and PUPSIT meant significant changes in the pharmaceutical sector. In this article, we will illustrate the focus areas of Annex 1 and will discuss main aspects of PUPSIT.

Khalil Essani - Single Use Support

Khalil Essani

March 13, 2024

Recommended Downloads

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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.

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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

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