Industry Insights

  1. What Does 'Room Temperature' Mean In Pharmaceutical Storage?

    For those products where ‘room temperature’ storage is a requirement, there is a continuous and ever-increasing demand from a wide variety of regulators for manufacturers to ensure the efficacy of products, previously thought not to need temperature control during transportation, storage and distribution. 

  2. Tips For Performing Preparative Chromatography and Protein Purification

    Separating out a protein from a complex mixture is not an easy task. Many hours are spent by bioprocessing scientists trying to purify their favorite protein to homogeneity in order to study the functional properties or to manufacture a large-scale preparation for production or potentially clinical use. Even 1% contaminant in an otherwise highly purified protein preparation, can reek havoc in a functional assay or structural protein study not to mention in the drug discovery process.

  3. Methods Of Containment For Solid Dose Blending And Manufacturing

    Two methods of containing blenders have been demonstrated. Included here are the use of flexible enclosures and separate, disposable powder transfer systems.

  4. Impact Of Incorrect Forecasts On New Drug Product Launches

    Pharmaceutical company marketing executives have become more accurate in positioning their new product in the marketplace, profiling prescribers, and understanding and responding to the reimbursement landscape. What is still a quagmire for pharma companies is predicting the actual demand for products and the timing of that demand.

  5. The Right Biomanufacturing Partner Can Improve Flexibility And Mitigate Risks From Forecasting

    While forecasts can never be 100% accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible. To reduce the impact of inaccurate forecasting over the life cycle of a product, companies need to focus on those variables that they have the most control over.

  6. Keeping The Patient At The Center Of Drug Delivery Devices

    Healthcare is increasingly moving out of the hospital and into the home as self-administration of medications becomes more cost-effective. As the population ages, and people live longer with chronic conditions, the need for safe and effective drug delivery devices will continue to increase.

  7. Designing A Biomanufacturing Facility Incorporating Single-Use Technologies

    The benefits of adopting single-use technologies in the production of biopharmaceuticals, such as lower capital investment and increased flexibility, are now well documented and widely recognized in the industry. But when building a new facility based on single-use technologies, or incorporating single-use into an existing facility, how do companies ensure they fully realize the benefits?

  8. What A Successful CMO For Diagnostic Consumables Looks Like

    The intricacy of emerging diagnostic consumables necessitates manufacturing competencies that span a wide range of disciplines. As diagnostic companies continue to develop complex consumables, the need for a strong relationship with a consumable diagnostics CMO specializing in everything from early product design to final product manufacturing will become increasingly more important.

  9. How To Avoid 5 LIMS Nightmares

    Traditional Laboratory Information Management System (LIMS) implementations are notorious for keeping people awake at night. Industry analysts like Strategic Directions and ARC Advisory Group have estimated the failure rate of commercial LIMS solutions to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.

  10. Solutions to Today’s Biomanufacturing Challenges

    With more complex molecules in development, changing capacity needs, uncertain forecasts and increased competition, the market demands flexibility and innovative approaches to address today’s new challenges.