Industry Insights

  1. Making Novel Therapies A Reality Part 1

    Cell therapy, gene therapy, and RNA-based therapies. Right now, those are the classes of therapies we’re considering novel. If you look at it historically, ten years ago, recombinant proteins and monoclonal antibodies would have been novel therapies, but now they’ve become very much standardized. So now that bar has moved a little bit, and the novel therapies are really cell and gene therapies, and to a certain extent the RNA therapies.

  2. Top Five Tips For Chromatography Sample Preparation

    Chromatography comprises a group of molecular separation techniques commonly used in proteomics to isolate proteins of interest from heterogeneous samples. Despite the fact that these methods are purification strategies in their own right, it would be ill advised to introduce crude sample to your chromatography setup from the outset. The vast majority of samples encountered require some form of processing before they can be placed on the analytical instrument.

  3. The Multivariate World Is Expanding For Research And Industrial Data Analysis

    The field of chemometrics has been around for quite some time now and has played its role in both research and industrial environments. While the multivariate research toolbox is well established and ever increasing, its industrial counterpart is only beginning to see widespread use in the last decade.

  4. Biosimilars Producer, Alvotech, Finds Opportunities In Iceland

    In June 2016, Alvotech opened their new biosimilar manufacturing facility in Reykjavik, Iceland, using best of breed solutions from leading Life Science vendors.  The key directive for Alvotech was to create a flexible, agile process which could adapt and be used for any conceivable process.  The result:  A high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System. 

  5. Integrating Quality Control Tools Into Print Workflow Automation Solutions

    Artwork must be right the first time and every time. Even a simple mistake has the potential to be catastrophic, resulting in product recalls, fines, write-offs and potential lawsuits.

  6. The Standardization Of Single-Use Components For Bioprocessing

    As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization. 

  7. How Do You Inspect Packaging Of Bottles, Cans And Cylinders?

    To ensure the package is error free, progressive companies now use automated proofreading solutions throughout the design and printing of the package and label.

  8. Demand Led Supply Chain Approach Gets Medications To Clinical Sites Quickly

    An important measure of success of any clinical supply chain strategy is whether or not clinical sites have the necessary study medications at the ready when needed to avoid delays in new patient starts or continuance of therapy. Forecasting and demand simulations are useful for anticipating when and where stock is likely to be needed to formulate a kit production and distribution strategy.

  9. Consultants’ Guide To Flexible Biomanufacturing Solutions

    Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients.

  10. 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.