White Papers

  1. When Clean Is Critical—The Importance Of Understanding The Parameters And Definitions Of Clean
    11/15/2019

    Working within a critical environment such as a clean room necessitates high-quality materials and equipment. To provide products that meet the needs of the applications, materials and consumables must conform to a variety of specified standards. This white paper explains how clean parameters are defined and validated.

  2. Benefits Of Pharmaceutical Quality By Design (QbD): Considerations For Drug-Device Combination Products And Partnerships
    11/11/2019

    Quality by Design (QbD) achieves quality through understanding of all components and processes, with a detailed understanding of risks and how they can be mitigated. This article considers how West Pharmaceutical Services, Inc. (West) employs QbD for elastomer components – in particular NovaPure® plungers for prefilled syringes.

  3. The Importance Of An Analytical Testing Strategy For Combination Products
    11/8/2019

    As combination products evolve and a preference for self-administration systems such as prefilled syringes, auto-injectors, and pen injectors commercialize, there is a need to ensure proper testing of both the primary and secondary components in compliance with regulatory guidelines. The combination product development process to focus on the user-friendliness, or human factors, of self-administration systems, very often involves new and innovative drug products. One crucial aspect of this process focuses on regulatory submission. A foundational point that tends to be overlooked, and required for regulatory submission, is the analytical testing strategy that supports the combination product development process, whether at the stages of concept, feasibility, development, or product release.

  4. Responding To Market Trends In Prefilled Delivery: A Review Of Component Assessment And Selection
    11/8/2019

    As the industry continues to see significant growth for drug products developed in prefilled syringe (PFS) technologies, there is a trend for pharmaceutical companies to evaluate more complex drug molecules that require delivery systems. The biologics are typically intended for self-administration by the patient and integrate a PFS with an auto-injector to optimize safety, dose accuracy, and ease of use. However, existing plunger technology for PFS was developed for manual injection and does not meet the evolving requirements for drug delivery especially for consistency of injection rate.

  5. Lentiviral Vector Scale-Up Workflow In Single-Use Bioreactors Enables GMP Compliance
    11/8/2019

    As gene transfer vehicles, lentiviruses exhibit many desirable properties, such as high transduction efficiencies, ability to infect both dividing and nondividing cells, and stable integration into the host cell genome. These properties make them well-suited for in vivo and ex vivo gene and cell therapies. However, cost-effective manufacturing of lentiviral vectors (LV) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.

  6. Can You Afford Not To Outsource Buffer Preparation?
    11/4/2019

    The decision whether or not to outsource buffer preparation is not clear-cut, but provides an opportunity to balance risk with reward.

  7. Single-Use Platforms Accelerate Viral Vaccine Development And Manufacturing
    10/31/2019

    Analyses of the biopharmaceutical industry predict that the market for vaccines could grow at a compound annual growth rate of as much as 10.3% between 2013 and 2024. The vaccine industry requires new tools to help bring its pipeline of new products to the market quickly, safely, and economically. Read how Sartorius Stedim Biotech (SSB) is exploring the best ways of implementing single-use platforms for next-generation vaccines that avoid reinventing the wheel for each candidate, thereby reducing time to market, lowering production costs, lowering risks, and increasing flexibility.

  8. Single-Use Systems For Vaccine Manufacturing
    10/29/2019

    To meet global demand, it is predicted that next generation vaccines will be based on recombinant approaches and be produced in intensified single-use systems (SUS) to increase capacity at reduced costs. However, despite their benefits, SUS for vaccine manufacturing face a number of key regulatory challenges, which require greater reliance by the biopharmaceutical industry on SUS suppliers. This article details how Sartorius Stedim Biotech (SSB) is leveraging its quality strategy to address these issues by partnering with polymer and film suppliers to combine material science, film extrusion and bag making expertise, allowing in-depth characterization and process control of extractables/leachables substances and particles profiles of its SUS.

  9. Integrated Tools For Upstream Process Intensification: Part II
    10/27/2019

    Changes to bioprocessing methodologies in the biopharmaceutical industry are being driven by the need for increased speed, a lower cost of goods (COGs) and greater flexibility. Faster development times are required to progress biologics and vaccines more rapidly into clinical development and then to market to improve worldwide accessibility. Continue reading in part 2 of this series how in order for intensified and continuous bioprocessing to deliver on these quality and productivity promises, there is a requirement for intelligently designed products.

  10. Integrated Tools For Upstream Process Intensification: Part I
    10/27/2019

    Changes to bioprocessing methodologies in the biopharmaceutical industry are being driven by the need for increased speed, a lower cost of goods (COGs) and greater flexibility. Faster development times are required to progress biologics and vaccines more rapidly into clinical development and then to market to improve worldwide accessibility. For intensified and continuous bioprocessing to deliver on these quality and productivity promises, there is a requirement for intelligently designed products.