Outsourced Pharma White Papers

  1. Scalable Strategies For Parenteral Dosage Form Selection
    12/29/2017

    Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.

     

  2. Digital Manufacturing Of Biologics
    2/19/2019

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. 

  3. Efficient Cleaning-In-Place Methods For Protein-Based Antibody Affinity Chromatography Resins
    10/2/2018

    This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.

  4. Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process
    5/30/2019

    This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.

  5. Flow Chemistry: Scale-Up Solution For Modern API Manufacturing
    2/20/2019

    Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.

  6. 6 Regulatory Changes Affecting Bioprocessing In China
    4/2/2019

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  7. Virus Safety For Continuous Processing
    9/5/2019

    Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.

  8. A Plasma Problem: Dwindling Supply In The Face Of A Growing Demand
    5/30/2019

    An outlook on the market shows plasma fractionators will have to look to innovation and other opportunities for supply, in order to meet the needs of patients.

  9. Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics
    9/11/2019

    Learn what challenges exist when developing biologic drugs to be efficacious but safe and how novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.

  10. Optimizing Process Efficiency In Upstream Manufacturing
    2/8/2019

    Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.