Industry Insights

  1. Biosimilar Manufacturer Builds Facility Designed For Drug Cost Savings

    Alvotech facility features 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.

  2. Designing A Biomanufacturing Facility Incorporating Single-Use Technologies

    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?

  3. 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.

  4. Keeping Your Cool When Storing Purified Protein

    The study of proteins and their function is central to understanding biology, but separating and purifying single proteins from complex mixtures is hard work. After investing the time to purify your target protein using various chromatography methods, losing your protein integrity because of improper storage would be devastating. Good storage conditions are particularly important if you need your protein for several downstream studies. You might need to store your preparation for an extended period of time, and some experiments require that the protein retain its original structure, binding affinity or enzymatic activity. Here we discuss some quick and simple suggestions relating to concentration, additives, sample size and storage temperature to consider when storing your protein for future use.

  5. Autologous Cell Therapies At Crossroads With FDA: What To Do Now?

    Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?

  6. Bioburden Sources You Might Have Missed

    A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.

  7. Expanding Single-Use Biomanufacturing Into New Locations

    If you have decided to add capacity in-house, you need to consider which location enables you to meet demand. Having knowledge of the local operating environment and regulatory considerations is vital. 

  8. BPOG Extractables Testing Protocols: Working With Multiple Single-Use Components

    Understand the analytical challenges faced when implementing the BPOG protocol for four SUS components.

  9. A New Process For Reducing Glass Breakage

    Glass breakage is commonly acknowledged as a major nuisance in parenteral manufacturing. It causes a plethora of problems, such as disruption of production, particle contamination and loss of sterility.

  10. Strategies For API Solubility And Bioavailability Enhancement: Selecting Technologies And Excipients

    Bypassing conventional trial-and-error methods for solubility challenges and excipient selection can eliminate unnecessary testing, improve the efficacy of your formulation, and increase your overall speed to market.