Guest Columns

31. 4 (More) Critical Considerations For Drug Delivery Device Development 8/12/2019

    The majority of biologic products today are launched as some form of combination product, stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

32. Asia Bioprocessing Capacity Trends: Overall Growth, But Cell Therapy Shortages Loom 8/8/2019

    Overall, the growth in Asia’s bioprocessing capacity, particularly in China, has been impressive, albeit from a low baseline. Capacity growth over the past five years has been over 20 percent annually. New facility construction and expansions reflect the demand for biologics for domestic consumption, while other facilities are beginning to develop manufacturing strategies for GMP production for major markets, with capacity involving commercial-scale stainless steel and single-use bioreactors.

33. 4 Important Things To Consider Before Developing A Drug Delivery Device 8/6/2019

    This is Part 1 of a two-part article discussing important areas to consider when developing devices for combination products — and why they need to be addressed early in development. In this installment, we will look at the areas of primary container, device development, device selection, and design control.

34. 2019 U.S. State Policy Trends Impacting Pharma Manufacturers 7/31/2019

    If the activity happening in state legislatures across the country heralds change at the federal level — and it likely does — pharmaceutical manufacturers ought to buckle their seatbelts.

35. How 2 Recent Court Cases Could Impact Follow-On Biologics Strategy 7/23/2019

    As follow-on biologics litigation expands, and the FDA provides additional information on the approval process for follow-on biologics, industry and observers are gaining clarity on how the Biologics Price Competition and Innovation Act (BPCIA) functions in practice. This article provides insight into two recent developments that will impact strategic and economic considerations for biologics developers.

36. Applications For Single-Use Systems In Biosimilar Development 7/16/2019

    Exploring the benefits, challenges, and future of disposable systems in biosimilar manufacturing.

37. IPR For Biosimilars: Examining The Benefits And Drawbacks 7/11/2019

    Whether Inter Partes Review (IPR) is the right choice for biosimilar developers will depend on the particular circumstances surrounding each drug candidate. But given the benefits of IPR proceedings, they must at least be considered as a potential tool for challenging patents.

38. 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. 

39. Bio/Pharma Maintenance 4.0: How To Get Started 7/5/2019

    Part 1 of this two-part series looked at the core aspects of Maintenance 4.0 and outlined a comprehensive maintenance process flow. In this second part, we will discuss how to get started with Maintenance 4.0, along with how to develop benchmark metrics that allow assessment of the gap between the current and desired states.

40. Maintenance 4.0: The Next Revolution In Bio/Pharma Manufacturing 6/21/2019

    The next stage in maintenance management, Maintenance 4.0, is to go beyond predictive to the initial stage of an asset — commissioning the assets and deploying the same tools and techniques to set the measures within the design specification from the beginning onward, and using indicative measures to keep the asset in its original design specification.