Expert Insights On Fill/Finish

  1. 4 Key Usability Considerations For Biopharmaceutical Delivery Device Design 7/9/2019

    Often, the last thing on the minds of drug development teams working is the human factors engineering (HFE) performance of the drug delivery devices that will ultimately deliver their innovative medications to patients. Yet, such an oversight can cause major delays in delivering these new medications to market. 

  2. Mystery And Danger: Flammables And Oxidizers In Pharma Filling Operations 5/21/2019

    BPO, benzyl peroxide, a compound that has both a fuel source and oxygen (two legs of the fire triangle) built into it, can make handling of a purified version of this compound very interesting. 

  3. Training Production Operators In Aseptic Technique: Common Pitfalls And How To Avoid Them 5/2/2019

    Retraining an operator involved in a microbiological excursion is almost always part of the corrective and preventative action (CAPA), yet repeat excursions and deviations due to improper aseptic technique still routinely occur. So, why do some operators still have difficulty executing the task after completing such intensive training programs?

  4. Not Your Grandma's Aseptic Filling Line: Letting Go Of Tunnels, Washers, And Other Aseptic Vestiges 3/8/2019

    We often work with organizations adding capacity, transferring new products, and adding existing products from other sites into their “preferred” plants. In each case, the receiving site is focused on schedule and budget. These competing targets often distract personnel from embracing newer technologies, bypassing lower-cost options and faster implementation. 

  5. How Technology Will Reshape The Future Of Aseptic Processing 2/11/2019

    Using new and existing technologies to improve aseptic processing manufacturing may provide the need and opportunity for new approaches to process control and monitoring. 

  6. Overcoming The Unique Filling Challenges Of Autologous Therapies 2/5/2019

    Autologous (patient-derived) therapies represent unique challenges to processing. One-patient, single-batch is a radical change from the scale our industry is accustomed to. At this level the filling is more analogous to limited Phase 1 clinical trial materials or even preclinical applications. The logistics and required compliance of manufacturing these personalized therapies is drastically different and presents a combinatorial explosive problem. One aspect of this process where traditional methods fall apart is filling of these therapies.

  7. Reimagining Aseptic Processing: What Must Change? 1/21/2019

    This is the second in a three-part series exploring the need to achieve improvement in aseptic processing of sterile biopharma products. Part 1 presented the current state and opportunity for improvement using innovative technology. Part 2 discusses changes in strategy that might be needed as a result of technology implementations. 

  8. Single-Use For Fill-Finish: Is It Worth The Risk? 11/7/2016

    Single-use technology is a potential solution to some of the problems that have long plagued the fill-finish portion of the pharmaceutical manufacturing process. Aging facilities can contribute to some of those problems, as can capacity issues, where changeover times limit the pace of manufacture.

  9. New Biologics Create Need For Patient-Friendly Injectors 3/8/2016

    Analysts forecast that by the end of 2016, 50 percent of the top 100 drugs on the market will be biologics. Currently more than 900 biologic drugs are in development to treat a broad range of conditions, including cancers, immunologic disorders, and rare and chronic diseases. That the majority of new injectable treatments are biologics will present a new challenge in delivery of the medicines.