Biosimilar White Papers

  1. Addressing The Evolving Needs Of Variable Drug Delivery Regimens 9/14/2020

    Pharmaceutical companies now have a wearable solution designed to enable new delivery formats in alternate settings and for customization to support adjustments to existing formulations and variations in treatment regimens.

  2. Standardizing Vein-To-Vein Logistics To Reach More Patients 2/24/2020

    Collaboration is  key to solving data management and process variability challenges as stakeholders work towards a common goal—getting life-saving treatments to those who need them.

  3. Considerations For Upstream Biologic Development 11/12/2019

    A biologic candidate's path from DNA to drug-in-vial is long and complex. These considerations might simplify and improve the economics of the process, helping molecules get to market as quickly as possible.

  4. Not Everyone Loves Surprises: Know Your ADC’s Critical Quality Attributes 2/21/2020

    Combatting the challenges of developing and manufacturing ADCs requires robust product characterization throughout all phases of development.

  5. Seed Train Intensification Using High Cell Density Cryopreservation 5/14/2020

    High cell density cryopreservation and the use of a perfused seed train and specially-designed expansion medium can create shorter lead times, reduce plant footprint, increase flexibility and reduce COGs.

  6. Addressing The Evolving Information And Automation Needs Of Biopharma 10/26/2020

    A dramatic increase in the information available, in parallel with a reduction in the cost of obtaining, processing, and transmitting information, is changing the way biopharma manufacturers operate. 

  7. Rapid Biosafety Testing Enables The Future Of Manufacturing 7/15/2020

    This whitepaper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing that are more aligned with manufacturing trends.

  8. Alternatives To In Vivo Assays For Biosafety Testing Of Biologics 3/31/2020

    Even as alternative methods such as PCR and NGS have emerged, in vivo tests have stubbornly remained a central part of testing. Here we examine current in vivo methods and explore modern alternatives.

  9. Strategies To Address The Viral Vector Manufacturing Shortage 3/5/2020

    Accelerating the production of your viral-vector based therapy requires understanding the strategies and cost-efficiencies available to address the viral vector manufacturing shortage.

  10. Accelerate Process Intensification For Viral Vaccine Manufacturing 7/23/2020

    This article details an integrated portfolio of technologies to facilitate process intensification of viral-based vaccines including SARS-CoV-2 vaccine candidates.