Industry Insights

  1. Eliminate Unwanted Immune Response In Biotherapeutics

    The issue of immunogenicity is known to have a detrimental effect on both the efficacy and safety of a biopharmaceutical but is often not considered until clinical trials. To address this issue, Lonza has developed a comprehensive set of preclinical safety and immunogenicity risk assessment tools to aid lead selection and characterization.

  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. Ensuring Barcode Accuracy From Packaging To The Patient

    Barcodes have changed very little over the last 60 years. Yet for pharmaceutical companies the barcode has taken on a vital role throughout the product’s lifecycle from original packaging to in hospital unit dose identification.

  4. 4 Steps For Reducing The Risks Of Temperature Excursion

    In clinical trials, the cold chain is far from a secondary concern. When it comes to temperature-sensitive products (tissue samples, cell banks, APIs), any temperature excursion can prove detrimental to the shipment, and ultimately to the trial. Supply chains are not always predictable or easy to control, and pharma companies need to take a proactive approach to risk management. Sue Lee, technical portfolio manager at World Courier, explains how companies can determine their risks and plan a shipment strategy accordingly.

  5. Simplifying Recombinant Protein Production

    Biologic drugs have great promise, but they are complex and, as a result, are very expensive to manufacture and subject to technical pitfalls. 

  6. Tackling The Challenge Of Scalability

    Commercial production of biologics requires development of a fermentation process that is time- and cost-efficient, and highly reliable. In an early stage of development, many process parameters are evaluated at small or bench scale to find the optimal conditions.

  7. How Many FDA Premarket Applications Are Necessary For Your Combination Product?

    Often, an already-approved drug can further benefit patients when applied with a medical device. In such cases, the pharmaceutical product sponsor may utilize the 505(b)(2) pathway for regulatory approval of the combination product. But even when the regulatory pathway is known, submission strategies for regulatory approval of combination products can be challenging and confusing. The development and review of combination products in the U.S. typically requires the involvement of multiple centers within the Food and Drug Administration (FDA), under the oversight of the FDA’s Office of Combination Products (OCP).

  8. Different Environments Where Bacterial Endotoxins Can Be Found

    Bacterial endotoxins originate from Gram-negative bacteria, which, after death, are released to the environment where they encounter lipopolysaccharides. These endotoxins are considered to be the most frequently reported pyrogens. Bacterial endotoxins cause infections that can be very serious, which may even lead to the death of human beings.

  9. 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.

  10. The Right Biomanufacturing Partner Can Mitigate Forecasting Risks

    While forecasts can never be 100% accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible.