Knowledge

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!

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.

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. 

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.

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.

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. 

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. 

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.

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.

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.

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!

Freezing large volumes of drug substance can be a challenging endeavor. In this article, we will discuss main considerations as well as possible solutions for this delicate process.