Industry Insights

  1. 5 Questions To Answer Before Starting Your CMO Search

    Finding the CMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Some companies, especially those with limited experience in the biopharmaceutical industry, may find themselves unprepared when it comes to beginning the search.

  2. Incorporate Data Integrity Into Your Pharma Quality Management System

    A viable QMS cannot be based upon anything except data and records that are attributable, legible, contemporaneous, original, accurate, complete and easily retrievable. 

  3. Ensuring The Greatest Return From Your Poorly Soluble Molecule

    Currently, about 70% of new molecular entities (NMEs) exhibit poor solubility in water and require some form of enhancement in order to achieve sufficient bioavailability, leading to tough questions about how to proceed for biopharmaceutical companies developing such compounds.

  4. Overcoming Obstacles In Final Ultra-Filtration Steps

    When preparing your pharmaceutical product for the vial, ultra-filtration is the final step in its purification process – just before final bulk filtration. Despite the importance of the end-purification steps and the great challenges that bioprocess engineers must contend with during this phase, there isn’t much literature on the topic.

  5. The Standardization Of Single-Use Components For Bioprocessing

    As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. 

  6. 6 Types Of Diseases In Humans Related To Endotoxins Of Gram-Negative Bacteria

    By entering the bloodstream, Gram-negative bacteria cause immune system reactions and lead to the activation of different chains of non-cellular reactions. One of the components of the cell wall of this family of bacteria are lipopolysaccharides, which form complexes of high molecular weight known as bacterial endotoxins, due to the toxic effect that they cause in other organisms.

  7. Bacterial Endotoxins As Contaminants Of Therapeutic Proteins

    The impurities of a therapeutic protein might be similar molecules obtained as part of the protein biosynthesis, or might come from the cellular substrate used in its production or from the production process itself.

  8. Recent Research On The Issue Of Bacterial Endotoxins

    Bacterial endotoxins are the most common pyrogens found in pharmaceutical products. These substances are found in the outer membrane of Gram-negative bacteria.

  9. The Relationship Between The Chemical Nature Of Bacterial Endotoxins And Their Toxicity And Immunogenicity

    The diseases related to Gram-negative bacteria affect humans and animals and, in many cases, are difficult to treat, which is why is important to have effective and bacteria-specific antibiotics.

  10. Evolution Of Large-Scale Chromatography Column Packing

    Chromatography has always played a crucial role in the purification of biologics. It has constantly evolved, and methods and capabilities have improved to reflect the industry requirements. This article gives an overview of how experience, innovation, and dialogue with customers led to the development of a platform that has revolutionized the economics of large-scale chromatography column packing.