Knowledge

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

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.

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. 

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.

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.

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.

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.

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

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.

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.

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.

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.