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Articles by Biopharmaceutical Products:

Articles by Manufacturing Processes:

Filling of drug substance: 5 threats you should know

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

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

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

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.

Michael Eder

January 16, 2024

Automated aliquoting system: From small volume aliquoting to bulk filling with RoSS.FILL

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.

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.

Michael Eder

January 16, 2024

Nucleic Acids

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.

Brian Moloney

January 8, 2024

Vaccines

Vaccine development: challenges & solutions

Vaccine development and manufacturing are a challenging business and in order to be efficient and successful manufacturers will have to adopt advanced technologies. The obstacles are manifold and the fragility of supply chains or requirements in cold chain management are just two of the challenges in vaccine manufacturing.

Brian Moloney

December 11, 2023

RoSS.FILL CGT Lab Scale_product photo (7 von 10)-min

Cell & Gene Therapy

Increasing Patient Safety: Risk assessment for small volume fluid management

Autologous therapies and other ATMPs with small volumes exhibit certain specific requirements. The scope of handling advanced therapies require special handling and care. When handling of small volumes is already automated in an early stage, it is a way more straightforward path to commercialization of the drug product. The benefit of a closed systems with automated solutions add value by offering a higher degree of sterility, safety, and process flexibility.

Brian Moloney

December 4, 2023

Freeze & Thaw

Advancements in Small Volumes Drug Freezing Techniques

Freezing small volumes extends beyond laboratory settings to include commercialized manufacturing processes for small batches in biomanufacturing, like cell banking, gene therapies utilizing viral vectors, lipid nanoparticles, and fill & finish procedures.

Alexander Fuchs

November 20, 2023

aav-production-efficiency-improvements-single-use-technology

Drug Delivery

AAV production & efficiency improvements with single-use technology

With adeno-associated virus being a popular viral vector, along with a growing interest in gene therapies, there is an increased need for cost-effective vector manufacturing technologies and viral vector production platforms for human gene therapy products.

Khalil Essani

November 19, 2023

Fill & Filtration

Liquid handling in biopharma: Efficiency gains with automated systems

Liquid handling is one of the cornerstones in countless biopharmaceutical manufacturing processes. In this article, we will illustrate how automated systems can improve efficiency – along with several other aspects.

Michael Mühlegger

November 16, 2023

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

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.