White Papers

  1. Human Factors Considerations For Combination Products

    For medical devices, the use of human factors and usability engineering (e.g., applying the knowledge of human behavior, abilities, and limitations to the design of a medical device) plays a key role.

  2. Containment: Top Industry Methods And Challenges

    Which methods are most prominent in the pharmaceutical containment industry today and what key challenges are pharmaceutical businesses facing.

  3. Considerations In HPAPI Containment Testing

    The global HPAPI market was valued at US$14.4 billion in 2016 and is expected to grow at a CAGR of 10.3 per cent, reaching US$34.8 billion by 2025.

  4. Viscous Products No Match For New Container Closure Integrity Technology

    New product types and packaging configurations, such as highly viscous formulations, pose a threat to traditional leak-testing methods, challenging current practices for container closure integrity testing. 

  5. Sustainability By Design

    Sustainability means a balancing act and the ability to maintain a certain regulatory standard and the approach of in-built sustainability is essential when designing biopharmaceutical facilities.

  6. Engineering For Sterile Product Manufacturing Facilities

    This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.

  7. Container Closure Integrity Testing Of Intravenous Bags

    A non-invasive, non-subjective solution that is capable of detecting package leaks and invisible defects using a differential pressure transducer leak test system.

  8. Performance Validation: HPAPI Containment Testing in A Risk-Based Era

    Key considerations linked to containment performance testing, data collection methods and the interpretation of results.

  9. Overview Of A Scale-Up Of A Cell-Based Influenza Virus Production Process Using Single-Use Bioprocessing Equipment

    This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.

  10. Platform Approach To Purification Of Bacterial Capsular Polysaccharides For Vaccine Production

    Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.