Bioprocessing White Papers

  1. Shaping The Future Of Formulation Development With Melt-Based 3D Printing Technologies 7/9/2021

    In this white paper, the use of 3D printing to overcome challenges during formulation development is explored, with a focus on enhancement of bioavailability of active pharmaceutical ingredients (APIs) in solid dispersions. It is estimated that 60–70% of drug substances currently in clinical pipelines are categorized as Class II in the Biopharmaceuticals Classification System (BCS) which indicates low solubility. For an oral formulation, the proper API solubility is critical for absorption in the gastrointestinal tract. If solubility issues cannot be overcome during formulation development, an otherwise promising therapeutic candidate may have to be abandoned.

  2. Preparing For The Green Light: Considerations For Post-Approval Biologics Manufacturing 7/6/2021

    Following clinical development and in preparation for approval, it is essential to plan for the commercial manufacturing of your cell culture media. Read about considerations before, during, and after clinical trials that can help you maintain the biologic drug approval status you have spent years working to achieve.

  3. From Meeting Demand To The New Normal: How Biologics Production Is Shifting In Response To SARS-CoV-2 7/6/2021

    Following the emergence of the novel coronavirus SARS-CoV-2, trends began to emerge in the industry during a period of rapid adaptation. What can we learn from the global crisis and which changes are likely here to stay?

  4. The Importance Of Compliance In R&D 6/29/2021

    Regardless of the industry an organization operates in, remaining compliant with ever-changing legislation is an important aspect of corporate operations. For businesses that focus on research and development (R&D) however, it’s essential. This is because of the frequently high-risk nature of the products being developed, and the potential for harm if there is an oversight during the testing process.

  5. Managing Frozen Transport Logistics In The Biopharmaceutical Cold Chain 6/28/2021

    As biopharmaceutical manufacturing grows increasingly global, the production and transport networks required to keep operations running smoothly become more complex.  This paper provides a framework for making challenging decisions linked to cold chain management before outlining potential solutions that could solve many of the issues surrounding the frozen transfer of biopharmaceuticals.

  6. Organoids: Ideal Model Systems For Disease And Drug Screening? 6/22/2021

    Successful organoid formation is dependent on many factors, all of which are crucial in fulfilling the potential of this powerful new tool for personalized medicine.

  7. Understanding Perfusion Terminology 6/7/2021

    Over the past several years, perfusion has become an increasingly attractive process for development in the biopharmaceutical industry. To fully evaluate whether a perfusion application will work in a production process, it is critical to have standardized terminology. This white paper explains key terms that are essential for understanding the process.

  8. How Successful CDMO Collaboration Sets The Foundation For Sterile Injectable Product Success 6/1/2021

    In the realm of Sterile Injectables, sponsors come in a variety of sizes and with a range of experience levels. The same is true for CDMOs, and the dynamics of these outsourcing relationships have a huge influence on project success. Explore how a small or medium size biotech or pharma company can benefit from the experience and assistance provided by a CDMO.

  9. Setting The Stage For Electronic Data Exchange 5/26/2021

    Digitization and automation, key elements of Bioprocessing 4.0, will be essential for this transformation, in which the industry will leave behind paper-based procedures, data silos, manual process control and equipment that cannot communicate with each other. Adoption of an electronic format for the exchange of data (referred to as eData) from suppliers of raw materials to biopharmaceutical manufacturers is an important step towards making Bioprocessing 4.0 a reality.

  10. Explore Protein Function Using Surface Plasmon Resonance (SPR) 5/20/2021

    We’ve collected a few examples of how an academic research group used Biacore™ X100 SPR system in their research to investigate protein-RNA, protein-protein interactions, and how researchers have used SPR to measure antibody specificity. Download the white paper A year of interaction with Biacore™ X100.