Bioprocessing White Papers

  1. How To Overcome Validation Challenges In A Single-Use World

    How can end users ensure the expected level of compliance in this new world of single-use systems? The secret: shared responsibility for validation with your supply chain.

  2. Insights And Tips When Addressing Bioburden Challenges

    This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

  3. Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing

    A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.

  4. Manufacturing Process Scale-Up For Phase III

    The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.

  5. Managing Demand Uncertainty In Biologics Production

    How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.

  6. Improving Compliance And Manufacturing Efficiency In Life Sciences

    Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. 

  7. Low Particulate Carboys Can Help Improve Biopharma And Vaccine Production

    Some products cannot be filtered prior to final fill, requiring a process which limits particulate-contributing factors wherever possible throughout manufacturing. Pre-cleaned, sterile, ready-to-use containers ease this burden.

  8. Leverage The Internet Of Things Within The Laboratory

    As science-based organizations look to leverage the internet of things (IoT) within the laboratory, careful consideration must be given to available technologies, data formats, and platforms. 

  9. Pharma Production Tech Transfers: Reaping Rewards, Reducing Risks

    Transferring production — and the technologies that undergird it — can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.

  10. 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.