Freezing drug substances to ultra-cold temperatures is a standard step in biopharmaceutical manufacturing. Yet, beyond simply cooling, it’s the critical quality attributes (CQA), like product safety, consistency, and process efficiency, that trul...
With the rapid advancements in biotechnology and the growing importance of protein-based therapeutics, ensuring the stability of proteins during storage has become paramount. Proper storage conditions are crucial for maintaining the structural ...
Therapeutic proteins have become indispensable tools for treating a wide range of diseases and medical conditions. These biologically derived molecules offer targeted solutions that can provide significant benefits over traditional pharmaceutic...
Protein production is a fundamental process in biotechnology, enabling the creation of essential molecules for medical, industrial, and research purposes. As demands for diagnostic and therapeutic proteins continue to rise, the implementation o...
The stability of proteins determines their ability to maintain their functional conformation under different environmental conditions, such as changes in temperature, pH, and solvent composition. It is an important aspect in pharmaceutical manu...
Khalil Essani, Product Line Manager at Single Use Support, is an expert in bioprocessing applications for single-use technologies. He provides valuable insights, advantages and solutions using cell banking in seed train intensification in the f...
Active Pharmaceutical Ingredients (APIs) are the cornerstone of pharmaceutical drugs, serving as the primary agents responsible for delivering therapeutic effects to patients. In this article, we give a definition of APIs and their significance...
Active Pharmaceutical Ingredients (APIs) are the backbone of pharmaceutical formulations, serving as the primary component responsible for the therapeutic effects of medications. However, many APIs are sensitive to environmental factors such as...
Ensuring the integrity of filtration processes is fundamental for the safety of bioprocessing. Among the array of methods available for assessing filter integrity, the bubble point test emerges as one of the most frequently used techniques. By scr...
Microbial and mammalian cell fermentation are important processes in the development of media and drug development for the production of biologics, most importantly vaccines. However, there are certain characteristics that differentiate them from ...
Filter integrity tests are essential in ensuring the reliability of biopharmaceutical processes – a stringent field governed by regulatory requirements such as those set forth by the FDA and GMP standards. These tests are critical components in up...
Annex 1 of GMP is a set of regulations guiding the manufacturing of sterile medicinal products, setting stringent regulations for biopharmaceutical processes. Within this set of regulations, PUPSIT stands out as a fundamental procedure to ensure t...
Addressing Challenges in Aseptic Filling Accurate and efficient filling of biopharmaceuticals in primary packagings, such as single-use bags and bottles, is crucial. Even the smallest deviations in the filling volume can have a huge impact on ...
