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Monoclonal Antibodies

Challenges in monoclonal antibody production

mAb production requires high levels of expertise and precision, as well as specialized equipment. Nonetheless, there are several challenges that manufacturers have to deal with.

Alexander Fuchs | Single Use Support

Alexander Fuchs

February 6, 2024

Monoclonal Antibodies

Antibody storage: preserving monoclonal antibodies

In many cases, antibodies need to be stored for varying time spans before further processing or administration. Hence, it is essential to mind the characteristic storage requirements of these valuable biologics.

Alexander Fuchs | Single Use Support

Alexander Fuchs

February 5, 2024

Monoclonal Antibodies

Solutions for automated aseptic filling of monoclonal antibodies

Filling monoclonal antibodies requires dedicated solutions that allow smooth and safe mAb processing. In this article, we will discuss some of the integral components in this procedure.

BRMO

Brian Moloney

February 5, 2024

Monoclonal Antibodies

What are monoclonal antibodies?

Monoclonal antibodies are frequently used in research, diagnostics, and therapeutics. But what makes them so special? In this article, we are going to find out!

micheal-eder

Michael Eder

January 18, 2024

Monoclonal Antibodies

Trends in monoclonal antibody production: Optimizing processes with single-use technology

Several trends are re-shaping monoclonal antibody manufacturing – from the minimized use of in vivo practices to the implementation of automated processes. In this article, we will highlight 5 current trends in mAb manufacturing.

Khalil Essani - Single Use Support

Khalil Essani

January 18, 2024

Monoclonal Antibodies

Scaling mAb production: From lab to large-scale

Scale-up has to be considered already in early stages of monoclonal antibody production. But what do manufacturers have to bear in mind? We'll find out in this article.

Alexander Fuchs | Single Use Support

Alexander Fuchs

January 18, 2024

Monoclonal Antibodies

Monoclonal antibody production process: a comprehensive guide

The monoclonal antibody manufacturing process is an essential cornerstone in research as well as in the production of diagnostic and therapeutic tools. Therefore, we will take a closer look at how mAbs are made – in this article.

Khalil Essani - Single Use Support

Khalil Essani

January 18, 2024

Fill & Filtration

Aseptic filling machines for pharmaceutical liquids

Aseptic filling machines are widely adopted in the biopharma industry. From individual components and equipment to considerations like scalability – in this article, we will take a closer look at these systems.

micheal-eder

Michael Eder

January 16, 2024

Fill & Filtration

Aseptic filling & processing of biologics

Many drug products require aseptic conditions along their entire production process. In this article, we will discuss essential considerations on aseptic filling in the biopharma industry.

micheal-eder

Michael Eder

January 16, 2024

Fill & Filtration

Aseptic filling of large volumes of drug substances

Especially in large volume drug manufacturing, aseptic filling can be a challenging yet all the more important task to ensure product safety and effectiveness. In this article, we will discuss what manufacturers ought to be aware of.

micheal-eder

Michael Eder

January 16, 2024

mRNA & LNPs

Single-use technology in mRNA manufacturing

MRNA manufacturing demands for highest accuracy, safety, and compliance. In this article, we will find out how single-use technologies can be used to achieve improvements for mRNA production and processing.

BRMO

Brian Moloney

January 8, 2024

Vaccines

Meeting cGMP standards for vaccine manufacturing

cGMP plays a fundamental role in several stages of vaccine manufacturing. In this article, we will examine this role in more detail, including its manifold implications for vaccine manufacturers.

BRMO

Brian Moloney

December 11, 2023

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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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Whitepaper: Automated Aseptic Filling

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