Industry Insights

  1. Tips For Preparing Process-Scale Chromatography Columns

    caling up from laboratory-scale to process-scale purification is one of the most important manufacturing activities for the pharmaceutical industry. However, many challenges exist in this activity.

  2. Selecting The Optimal Resins For Mammalian Virus Process Purification And Clearance

    The success of biologics for use in humans depends on the ability to effectively remove any viral contaminants. Viral Clearance from biologics is critical to their performance since they can directly infect mammalian cells and cause diseases such as AIDS, mumps, measles, herpes, hepatitis, meningitis, and shingles. And, conversely, studying these disease causing viruses can aid in the development of preventive and curative therapeutics. In this article, Bio-Rad provides snapshots of the different apatite-based media that can be effectively utilized for the process-scale purification of small to mid-sized viruses.

  3. 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.

  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. Which Test Is Appropriate For Container Closure Integrity?

    Validation of container integrity must demonstrate no penetration of microbial contamination or gain or loss of any chemical or physical parameter deemed necessary to protect the product.

  6. 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.

  7. 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.

  8. 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.

  9. 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?

  10. Important Considerations For Lab Scale Protein Purification

    Protein purification at the lab scale bridges the gap between small-scale exploratory protein purification and high-throughput operations, such as industrial- scale manufacturing. At the larger end of the scale, advances in upstream processing such as improved fermentation capacities have led to increased amounts of crude sample available for input. Despite this meaning higher potential yields of target proteins, it also poses an enormous challenge for timely and cost effective sample processing further downstream. This challenge is made even more difficult as scale increases due to higher amounts of impurities — a result of prolonged fermentation times and higher cell densities in large-scale cell cultures.