Outsourced Pharma White Papers

  1. The Growth Of Sterile Injectables 6/1/2023

    Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.

  2. Can Yeast Be The Future Of Efficient Subunit Vaccine Manufacturing? 9/11/2023

    To aid in the manufacturing of new vaccines, Pichia pastoris yeast, a promising protein expression system, could be the perfect solution.

  3. The Role Of The Technical Transfer Executive Sponsor 10/30/2023

    Explore the importance of understanding a CDMO’s flexibility and culture, models and scale of equipment, technical capabilities, regulatory support, quality system, and executive sponsorship model.

  4. 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.

  5. Intro To USP <1062> - What It Is And Why You Should Use It 7/20/2023

    Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.

  6. Extractables And Leachables: Risk Management And Analytical Solutions 10/11/2023

    Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.

  7. How Can The Industry Drive Down The Cost Of Viral Gene Therapies? 4/5/2023

    This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.

  8. Switching To Direct-To-Patient Rapidly In The EU 10/4/2022

    Explore the logistical risk management factors to consider when deciding to switch to direct-to-patient shipments in the EU.

  9. Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars 2/9/2024

    The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.

  10. Match Your Development And Manufacturing Path To Your IND Milestones 2/17/2023

    The drug development journey is long, expensive, resource straining, and risky. Discover how to maximize the value of early phase material and match your development path to your IND milestones.