Outsourced Pharma White Papers

  1. The Medicines Of Tomorrow: A Primer On The Gene Editing Landscape 8/8/2023

    Learn about the distinction between gene therapy and gene editing, as well as the therapeutic potential of CRISPR treatments and the challenges associated with clinical trials and commercialization.

  2. Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs 8/14/2023

    Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.

  3. 5 Steps To Design A Microbiological Performance Qualification For Facilities 4/21/2025
    Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
  4. CGMP-Validated RCL Assay Used For Release Testing Of Manufactured Viruses, Gene Mediated Cell Therapy Products 3/5/2025

    Ensure the safety and efficacy of lentiviral-based therapies by addressing the risks of replication-competent lentiviruses (RCLs) through advanced monitoring and control strategies.

  5. Building Local Biomanufacturing Capacity In South Africa 2/11/2025

    Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.

  6. Enabling Digital Twins With Computational Fluid Dynamics Modeling 1/16/2025

    Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.

  7. Application Of Plant And Process Models 1/22/2025

    Explore innovative process and facility models that optimize efficiency, sustainability, and cost-effectiveness in biopharmaceutical manufacturing.

  8. White Paper: Spray Drying Biologics: An Alternative To Freeze Drying 10/16/2024

    Explore how innovative drying technologies can enhance the stability and efficacy of biologics, ensuring successful outcomes in this rapidly growing sector of the pharmaceutical industry.

  9. Small Molecule API Production: Unveiling The Impact Of Fermentation 5/16/2024

    Technological developments have led to growth in the suitability of fermentation for a myriad of applications. Explore the impact of the evolution of synthetic biology and supporting technologies on modern fermentation practice.

  10. Quality By Design: The Importance Of Reference Standards In Drug Development 8/1/2024

    Learn more about the comprehensive lifecycle management of reference standards, encompassing qualification, characterization, and storage procedures.