Knowledge

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.

There are various approaches to validate the integrity of sterile filters, as is required by several regulatory frameworks. We will cover some of the most common methods in this article.

Progress in the pharmaceutical industry is significantly driven by CDMOs, collaborating with pharma companies. In this article, we will put 7 outstanding CDMOs in the spotlight.

Both CMOs and CDMOs are frequently relied on partners in the pharmaceutical industry. But what sets them apart, where are their strengths, and what do they offer?