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. Industry 4.0: Embracing Digital Transformation In Bioprocessing

    In Industry 4.0, cyber-physical systems control and monitor activity through computer-based algorithms. In bioprocessing, there are a plethora of possibilities that could be realized over time through this revolution. 

  3. Utility Of GMP Next-Generation Sequencing (NGS) For Biosafety Assessment Of Biological Products

    By delivering significantly more data than traditional Sanger-based sequencing methods, NGS opens a range of possibilities for the analysis of diverse DNA and RNA populations.

  4. Bioburden Entry Points In Downstream Processing

    Tips to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved.

  5. Comprehensive Solutions For Aggregate Issues

    Aggregate molecules are mostly physically and chemically similar to monomers, their presence in the final purified product, especially a therapeutic mAb, is undesirable due to multiple reasons. 

  6. Pharma Liquid Filling Systems — Comparison And Selection Guide

    Having sold filling lines for all types of liquid pharmaceutical products (hundreds of lines in aggregate), Bosch Packaging Technology is in a unique position to advise on filling system selection.

  7. Choosing Your Single-Use Technology Supplier

    Choosing a supplier with a strong quality and supply track record, as well as broad technology platform and deep bioprocessing expertise, will simplify the entire process. To be a credible partner, they need to be able to provide technical and regulatory insight, understand your processing needs, be experienced in facility design, and provide advanced operator training and the right level of support to bring your capacity online faster.

  8. Modular Approaches for Diverse Molecules: Reinventing Smart Bioprocessing

    Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.

  9. How To Live With Uncertain Pharma Demand Forecasts

    The consequences of inaccurate demand forecasting can be reputational damage, market share loss, lost days of production, destruction of inventory, and layoffs.

  10. Single-Vendor CDMOs Bring Speed And Cost Savings To The Table

    As drug developers face the ever-pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help. At a CPhI North America panel on single-source CDMOs, four industry experts discussed how working with a single-source CDMO partner can accelerate time to market, add cost savings, and improve a formulation’s chances of achieving regulatory success.