Industry Insights

  1. The LAL Test: Precautions To Take When Conducting Research Into Pharmaceuticals

    For many decades, it has been found that the most effective method for determining pyrogens in pharmaceutical samples, regardless of the form of the active substance, is the LAL (Limulus Amebocyte Lysate) test. Using the LAL test, the presence of bacterial endotoxins, lipopolysaccharide molecules (LPS) that are part of the cell wall of Gram-negative bacteria, which are the most common and also the most dangerous pyrogens present in the products of the pharmaceutical industry, is determined.

  2. Drug Safety And The Importance Of ‘Last Mile Distribution’

    Inappropriate drug storage can reduce the quality of product, potentially affecting efficacy and safety, so manufacturers, patients and prescribers must be aware of these risks. World Courier looks at the importance of ‘last mile distribution’ to understand the effects it has on patient safety as well as cost for pharmaceutical companies.

  3. Good Manufacturing Practice: The DNA of Pharmaceutical Quality

    Good Manufacturing Practices or GMP's are the pharma industry’s fundamental guidance set up by regulatory authorities to describe what is necessary to manufacture safe, effective drugs. 

  4. The CAPA Detective

    Every industry has its detectives.  Mechanics and journalists hunt for leaks.  Software testers and security experts look for bugs.  Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore.  The level of intrigue may vary.

  5. One Region, A Thousand Challenges

    As the recent Economist Intelligence Unit survey showed, Asia remains an important region for biopharma, with some notable trends appearing for the next five years. We spoke about these findings with MilliporeSigma’s Julien Zhao (Biosimilar and Emerging Biotech Markets Manager, Asia) and MS Mahadevan (Head of Actives and Formulations, Asia Pacific) to hear their take on Asian market evolution, crossborder collaboration, and why countries like Indonesia might just be the future of the industry.

  6. Avoiding Collaboration Failure In Bio Pharma: Is It Possible? With The Cloud It Is.

    With the drug patent cliff continuing to cast a long shadow over biopharma, the industry is radically reinventing itself by embracing globalization and focusing on innovation and operational excellence. Most importantly, biopharma organizations are expanding externalized collaborative relationships beyond traditional boundaries and creating flexible networks of researchers — some in-house, others with industry and academic partners, research institutes and contract research organizations. These networks are increasing in size and complexity with many combining numerous partners with diverse project objectives. Externalized projects like this raise important data security and project management challenges.

  7. ULD Air Cargo Containers - Quality versus Redundancy – Where’s the Argument?

    In the engineering and manufacturing process, we think of a system failure backup as ‘redundant’.   However, in many cases, the development, installation and use of redundant systems can backfire and produce less, not more, reliability.

  8. Selecting The Optimal Resins For mAb Process Purification

    The development of monoclonal antibody (mAb) technology over the past 25 years has fundamentally changed the questions we ask and led to many innovative discoveries. These highly specific biological products have significantly influenced the direction and progress of research and therapeutics.

  9. Six Myths About Serialization

    Expect that serialization mandates will govern most of world’s drug supply. Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.

  10. Clinical Trial Opportunities In Emerging Southeast Asian Markets

    Southeast Asia is a growing pharmaceutical market with an increase in clinical trials in recent years. With a population of about 620 million and a total area of 4.5 million kilometres it contains the region’s well-recognised study destinations of Malaysia, Singapore and Thailand, who are also members of PIC/S the Pharmaceutical Inspection Co-operation Scheme. But what opportunities are there for multinational companies to embark on activity outside of these established centres?