Outsourced Pharma White Papers

  1. 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. 

  2. Standardizing Biosample Management - Why Use Collection Kits? 2/11/2019

    Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. Following are some basics to help with planning sample collection and to help make the process as cost-effective as possible.

  3. CMC Strategies For A Bispecific Antibody Platform For Cancer Immunotherapy 5/31/2019

    Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process. 

  4. Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective 6/11/2019

    There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

  5. Component Selection: The Key To Your Program Success 10/1/2019

    The increasing global adoption of injectable medicines creates demand for pre-filled syringes and vials. CDMOs that provide aseptic fill and finish services are actively responding to this increased demand.

  6. Critical Considerations About The Future Of Global Cell Culture Bioprocessing 4/2/2019

    In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

  7. 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.

  8. Choosing The Best Sterile Dosage Form For Your Phase 1 Needs 5/2/2018

    When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices — choices that can be conflicting or present differing advantages.

  9. Continuous Flow Manufacturing Of Pharmaceutical Ingredients 11/25/2019

    Strong growth is anticipated for continuous flow manufacturing of APIs as it offers important advantages over traditional batch manufacturing in terms of quality, safety, and sustainability of the overall process.

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

    Challenges exist when developing biologic drugs to be efficacious but safe. Novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.