Bioprocessing White Papers

  1. Smoke Signals – One Plant’s Secret For Assuring Aseptic Control

    Airflow visualization testing, conducted as part of a routine review program, can help assure that aseptic filling areas remain under a state of proper control.

  2. Selecting Filters To Address Your Bioburden Challenges

    Sterile filtration of liquids is vital to minimizing microbial contamination and ensuring product safety and integrity. Understanding the criteria for optimum filtering helps streamline product selection.

  3. De-Mystifying And De-Risking Process Development Through Early Engagement With A CDMO

    An overview of how CDMOs can help companies get started in the world of CGT manufacturing, with considerations around timing of engagement to maximize commercial and clinical success.

  4. Maximizing The Performance And Efficiency Of Your Sterilizing-Grade Filtration

    Selecting the right filter is the first step in reaping the benefits of today’s filters; optimizing their performance efficiency is key to maximizing the benefits for the lifetime of your process.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.