Bioprocessing White Papers

  1. Minimizing Sterile Filtration Risk Through Quality By Design

    Steps to ensure products are free from microbial contamination and achieve a sufficient level of risk mitigation against potential bioburden issues for these applications.

  2. Utilizing External Collaboration To Accelerate Vaccine Development

    Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.

  3. Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins

    This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

  4. The Evolution Of Anti-Body-Drug Manufacturing

    How ADC chemistry and manufacturing have evolved over the years, present the challenges this growth has created and describe how CDMOs are adapting to these changes to meet customer needs.

  5. Biosimilars: Regulatory Trends And Manufacturing Considerations

    Regulatory approval of a biosimilar requires comprehensive knowledge of both the process and the molecule while process development with the end goal in mind will help to achieve a robust manufacturing process.

  6. The Evolution Of Biopharmaceutical Facility Designs

    In the lifecycle of pharmaceutical and biopharmaceutical commercial manufacturing, the one constant has been change. With the advent of modern therapeutics, large scale commercial manufacturing became common place.

  7. 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.

  8. 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.

  9. Polyvinyl Alcohol: Revival Of A Long Lost Polymer

    Additional applications of PVA for sustained release and solubility enhancement that address specific challenges in pharmaceutical formulations.

  10. Qualification And Validation Of Isolator Systems

    Successful qualification and documentation processes start in the planning phase of a project, follow through manufacturing and lifecycle of the equipment.