Biosimilar Development insights

  1. Autologous Cell Therapies At A Crossroads With The FDA: What Can You Do to Help?

    Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies onsite. What does the pharmaceutical industry need to know — and, more importantly, do — to overcome it?

  2. Best Practices In Formulation And Lyophilization Development

    The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary structure, without unintended chemical modifications, and free of extrinsic and intrinsic particles. In many cases, a lyophilized formulation can provide the highest probability of technical success. A well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.

  3. 5 Key Considerations For Successfully Creating cGMP Single-Use Biomanufacturing Capacity

    Single-use technologies are being seen as the solution to flexibly and cost-effectively address many of the challenges around creating biologics manufacturing capacity.

  4. The Biggest Mistake You Can Make With Continuous Manufacturing And The FDA

    To allay fears about manufacturing changes, valuable tools are now in places by the FDA to facilitate these transitions. By not understanding the availability and value of these resources, manufacturers are making a sizeable mistake that could potentially impede the industry’s passage into the next phase of modernized manufacturing.

  5. 5 Key Considerations To Future-Proof Your Single-Use Biomanufacturing Capacity

    The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But beyond the flexibility of the single-use platform, you need to consider a range of other factors to ensure your capacity can will meet your long-term needs.

  6. 5 Key Considerations When Choosing A Single-Use Technology Supplier

    Choosing a supplier with a strong quality and supply track record, as well as broad technology platform and deep bioprocessing expertise, will simplify the entire process. To be a credible partner, they need to be able to provide technical and regulatory insight, understand your processing needs, be experienced in facility design, and provide advanced operator training and the right level of support to bring your capacity online faster.

  7. 5 Key Considerations When Choosing A Single-Use Bioreactor Platform

    In deciding which single-use platform to choose, reliability and robustness are fundamental requirements. Beyond process performance, it is important to consider how control systems and automation come into play, how easy it is to implement the platform, and if the design is flexible enough to support varying production volumes.

  8. 5 Key Considerations When Expanding Single-Use Biomanufacturing Into New Locations

    If you have decided to add capacity in-house, you need to consider which location enables you to most efficiently and effectively meet demand. Having knowledge of the local operating environment as well as regulatory considerations is vital. Where you don’t have this knowledge in-house, finding a supplier with first-hand experience of operating in a region can help fast track your project.

  9. 4 Key Considerations When Determining The Right Type Of Biomanufacturing Capacity

    In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.

  10. Biosimilar Analytical Similarity Assessments: Are You Testing Sufficient Innovator Lots?

    Analytical biosimilarity testing can be a controversial, complicated and uncertain topic. At BioOutsource, we recommend our clients take a stepwise orthogonal approach to aspects of analytical characterization.