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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

Bioprocessing

Bulk drug substance management

The following article aims to take a closer look at the term “bulk drug substance” and its meaning, as well as to investigate smart solutions to shorten the phase between development and blockbuster production. Read more about the solution for the biopharmaceutical industry!

Michael Eder

March 22, 2023

Vaccines

Filling of drug substance: 5 threats you should know

When it comes to the filling process of drug substances, there several aspects to be considered to achieve high-quality results with as little product loss as possible. In this article, we will discuss 5 major threats for the filling of drug substances.

Michael Eder

March 20, 2023

Single-use solutions for Microbial Production

Bioprocessing

Microbial Fermentation Manufacturing: Advances through single-use technologies

Microbial fermentation is a powerful, flexible microbiology process used to generate microbial cells or biomass such as proteins and enzymes for the production of vaccines and therapeutics. There are still some challenges to overcome. Many of these challenges in fermentation manufacturing can be solved by replacing traditional systems with single-use technologies.

Daniel Tischler

March 17, 2023

Single-use Technology

Biopharma packaging - requirements and solutions

In this article, we will discuss the special requirements of biologicals in terms of packaging as well as efficiency and sustainability aspects of biopharma packaging.

Michael Eder

March 16, 2023

Bioprocessing

Challenges in microbial fermentation manufacturing

Microbial fermentation manufacturing is an effective method for the production of APIs, bioconjugates and smaller biologicals that play an important role in biotechnology and the production of biopharmaceuticals. Manufacturers face different challenges during microbial fermentation. Explore the 7 biggest challenges, followed by the introduction of new solutions.

Daniel Tischler

March 16, 2023

Bioprocessing

Filling & Freezing large volumes for fermentation in less than 8 hours

The filling and freezing of large volumes for fermentation is an essential part during different production steps in upstream and downstream processing. In the following, we will explain why it is important to act fast and how an optimization of the process can be achieved.

Daniel Tischler

March 16, 2023

Single-use Technology

Primary and secondary packaging of drug substances

Throughout the manufacturing process of drug substances, the liquids must be transferred frequently, such as during the upstream and downstream processing. Safe packaging of large volume substances is of high necessity in each step. Protection is ensured by appropriate primary and secondary packaging. This article will provide an overview of the different types of primary and secondary packaging materials, which are used specifically for safe handling of drug substance.

Claus Exenberger

March 14, 2023

Bioprocessing

Cold chain handling for fermentation: Single-use solutions to lower costs

As expert for cold chain handling in bioprocessing, Single Use Support is providing solutions to meet challenges for safe storing and shipping associated with right freezing and thawing methods and temperature control for long-term storage. Their development approach leads to innovative systems that enable manufacturers to replace manual processes with fully automated end-to-end processes that not only push efficiency but also increase output.

Alexander Fuchs

March 14, 2023

Vaccines

Safe handling of bulk drug substances

When dealing with bulk drug substances, there are several risks to consider along the processing steps. Read more on the critical steps in bulk drug substance production and possible solutions – in this article.

Daniel Tischler

March 13, 2023

Bioprocessing

Microbial cGMP production: complete guide & manufacturer's overview

Microbial fermentation is a hot topic not only in the biopharma industry. In this article, you will find a brief overview of microbial fermentation manufacturing before we discover different CDMOs offering microbial cGMP production.

Michael Mühlegger

March 9, 2023

Vaccines

Thawing drug substance: best practices

For drug substances that undergo a freezing process during manufacturing, thawing at some point is only a logical consequence. However, there are several factors to be considered for this seemingly easy procedure – find out more in this article!

Michael Eder

March 8, 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

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.