Knowledge
March 21, 2024
What are Active Pharmaceutical Ingredients (APIs)?
Active Pharmaceutical Ingredients (APIs) are the cornerstone of pharmaceutical drugs, serving as the primary agents responsible for delivering therapeutic effects to patients.
March 21, 2024
Cold Storage Requirements for Active Pharmaceutical Ingredients
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.
March 20, 2024
Bubble point test: Purpose & Procedure
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.
March 20, 2024
Annex 1: All you need to know
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.
March 13, 2024
Annex 1 and the PUPSIT requirement
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.
March 13, 2024
Overview of filter integrity testing methods
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.
March 12, 2024
Top 7 pharmaceutical CDMOs in 2024
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.
March 12, 2024
CMO vs. CDMO: What are the differences?
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?
March 5, 2024
Single-use bag manufacturers: the major players
The advanced platforms of the newest generation of single use bags are generally compatible with a variety of bag brands and volumes. One of these platforms is Single Use Support’s RoSS®, which offers the benefit of not only being bag agnostic but also highly flexible thanks to its modular design. Learn more about the biggest player in the industry!
February 16, 2024
Study: Optimizing Cell Viability During CHO Cell Freezing
In a recent study, freezing protocols were tested with the RoSS.LN2F controlled liquid nitrogen freezer to find the optimal freezing rate for CHO-K1 cells in order to achieve maximum cell viability.
February 12, 2024
Who manufactures monoclonal antibodies? Overview of mAb companies
In this article we take a closer look at the top five companies in terms of annual revenue in the U.S., that dominate the field of antibody research, development and production. Further, we dive in the field of promising pioneers with a focus on mAb production for the use of cancer treatments.
February 8, 2024
Stressing Cells: The Role of Cryoprotectants in ATMP Cryopreservation
The objective of an optimal cryopreservation strategy is to deactivate (put on hold) degenerative cellular pathways and preserve proliferative potential by reducing the temperature below –130°C. To reduce the effects of ice crystal and osmotic injuries, cryopreservation protocols usually incorporate cryoprotective agents (CPAs).