1. Should Your Next Clinical Trial Use A New Supply Model?

    Clinical supply models need to provide for an adequate supply of patient kits that allow for variations in patient recruitment levels and clinical site activity. Traditional, or supply-led models, address this challenge by creating large quantities of finished patient kits upfront in order to create a cushion of static inventory to manage uneven demand. However, this cushion comes at a cost including lingering potential for stock-outs at high recruiting or new clinical sites, 30-200% drug waste and weeks or even months of lead time for packaging.

  2. Optimizing Your Clinical Supply Chain Strategy For Asia-Pacific Studies

    Widespread and diverse, the Asia-Pacific (APAC) region spans over two dozen countries where a population of over two billion and growing conduct business in more than a dozen major languages including Mandarin Chinese, English, French, Dutch, Korean, Japanese, Filipino, Vietnamese, Thai, Malay, and Khmer.

  3. Leveraging Forecasting Models To Optimize Clinical Trial Supply Management

    Explore how to drive excellence within the forecasting process and how to utilize forecasting throughout the study to plan for study clinical supply budgets and identify potential supply-related issues before they negatively impact your study.

  4. Around the World In Clinical Trials – New Regulations And Country Specific Challenges

    As certain regions of the world are added to a clinical study, the logistical and regulatory challenges associated with clinical trial supply distribution can rise exponentially. Underestimating the often complex distribution logistics necessitated by the sensitive and highly regulated nature of clinical supplies can potentially put a study’s budget and timeline—and more importantly, patients— at risk. Standards and accepted practices in one part of the world may be unacceptable in another.

  5. Maintaining Product Integrity In Biologic & Biosimilar Clinical Studies

    Specialized expertise in cold chain shipping and logistics are critical to avoid costly delays and potential for patient harm resulting from an interruption or delay in necessary clinical supply. Maintaining product integrity and reliability of supply can be especially challenging for biologic and biosimilar studies as the investigational and reference products will almost certainly require cold chain handling and may be high value, very limited in supply or require long lead times for new batches.

  6. Cleanroom Microbiology 101: Identifying & Controlling Sources Of Contamination

    Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects.

  7. Achieve Continuous Supply Of Drug Treatment For Study Requirements

    A small sized pharmaceutical company was approaching the final phases of a large phase III global multiple treatment arm oncology study that involved comparator drug. The study criteria required the client to provide study medication to patients active at the conclusion of the study until the drug would be commercially available, when it could then be prescribed to patients continuing treatment.

  8. Method For Optimizing mAb Polishing Using CMM HyperCel™ Mixed-Mode Cation Exchanger

    mAbs are produced for a number of therapeutic applications. However, mAbs are not a homogeneous family of products. Each mAb is unique, based on its isoelectric point, hydrophobicity and ability to aggregate. Additionally, the contaminant HCP content is process-dependent.

  9. Scale Up/Down Purification Study Using Mustang® XT Acrodisc® Membrane Adsorber

    Membrane chromatography is now routinely implemented in many large scale biotech processes to remove contaminating host cell proteins, DNA and viruses at high flow rate.

  10. A Disposable, Easy To Use And Effective Polishing Step In Monoclonal IgG1 Production

    Mustang Q membrane chromatography was evaluated as a polishing step following protein A affinity and cation exchange chromatography to remove residual host cell DNA during a Monoclonal antibody (MAb) purification process at 250 L cell culture production-scale.