Outsourced Pharma App Notes & Case Studies

  1. Targeted Therapies Drive Need For Flexible, Small-Volume Manufacturing
    5/2/2018

    Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies.

  2. Industry 4.0 Connects Machines And Data
    10/26/2018

    By applying remote monitoring, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers process reliability and product quality through connecting machines and data.

  3. Capacity And Performance Of MabSelect™ PrismA Protein A Chromatography Resin
    10/2/2018

    This application note demonstrates the binding capacity of MabSelect PrismA in comparison with its predecessor products for both polyclonal and monoclonal antibodies.

  4. 3 Steps To Better Extractables And Leachables Studies
    1/22/2019

    This summary just scratches the surface of the complexity involved in extractables and leachables studies, but it shows the value of aligning different recommendations to form a coherent strategy.

  5. End-To-End Process For Oncolytic Adenovirus Production
    3/20/2019

    Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.

  6. Scaling The Advanced Therapy Supply Chain
    2/13/2019

    Treating castration resistant prostate cancer means that failure within the advanced therapy supply chain has a catastrophic impact on patients. This case study describes the use of dispersed storage and cold chain logistics, around a central manufacturing facility to create a cost efficient and robust supply chain.

  7. Managing Risks To Time Critical Product Imports At Clinical Supply Depots
    6/11/2019

    Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.

  8. The Importance Of Proactive Clinical Returns Planning
    3/6/2018

    Accurate and timely delivery of clinical trial supplies helps to ensure that a study’s timeline stays on track. Sponsors often focus on upfront planning to ensure sites are prepared to reach clinical milestones but ignore the logistical challenges of reconciling and destroying clinical returns. This article breaks down how to effectively manage the clinical supply returns process and how to design a more holistic strategy.

  9. Improved Method for Determination of Adenovirus Concentration Using Surface Plasmon Resonance
    9/10/2018

    The performance of two assays for determination of adenovirus concentration based on surface plasmon resonance (SPR) is demonstrated in this application note.

  10. Bioburden Entry Points In Downstream Processing
    1/29/2018

    Tips to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved.