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WHITE PAPERS AND CASE STUDIES

• Warehouse Logistics Challenges? UWB Says, "Hold My Beer"

  Struggling with outdated RFID systems, see how Budweiser Budvar Brewery turned to Ultra-Wideband (UWB) technology to tackle its complex logistics challenge.

• Is Sustainability The Key To Agile Biopharma Manufacturing?

  In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.

• Mastering Technology Transfers: Our Blueprint For Success

  Uncover how this expert approach to process transfer supports reliable, scalable commercial manufacturing in the rapidly growing biopharmaceutical market.

• A Risk Assessment Study Of SARS-Cov-2 Propagation

  Explore the multicellular tropism of SARS-CoV-2 and the corresponding challenges for the manufacturing of cell therapies, where the material could potentially get infected at the source or during cell processing.

• Evaluating And Improving Apheresis Material Cryopreservation Processes

  Cryopreservation of apheresis offers many advantages but still presents manufacturing challenges such as cell clumping. The process requires attention in future studies as autologous cell therapies mature.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Deriving Reliable Clinical Outcome Scores From Continuous DHT Data

  DHT-derived endpoints, especially percentile-based metrics, hold promise for robust, scalable measurement in clinical trials—provided they're chosen statistically and with adherence in mind.

• Enabling Seamless Study Management Across Clinical Trial Phases

  Choosing the right eClinical solution can be difficult. Consider a platform’s various capabilities when deciding on a solution that performs and supports clinical trials at every study phase.

• Buffers And Process Liquids For Biopharmaceutical Production: Considerations For Scale-Up And Outsourcing

  For small and midsize biopharmaceutical organizations, outsourcing buffer and process liquid preparation, quality testing, and storage could significantly streamline operations and reduce regulatory risk.

• The 5 Ws Of A Human Factors Strategy

  A human factors strategy ensures medical products are safe, effective, and compliant by integrating user-focused design early, reducing risks, and optimizing regulatory approval processes.

• Bioconjugates – An Increasing Diversity, A Blossoming Of Therapeutic Applications

  Harness the power of bioconjugation to revolutionize targeted therapies, enhance drug efficacy, and reduce side effects, paving the way for more precise and effective treatments across a range of diseases.

• Navigating The Complexities Of CGTs With Regulatory And CMC Expertise

  Review the submission process and CMC expertise which helped a biopharmaceutical company targeting a rare-disease tumor type avoid a clinical hold and advance to phase 1 clinical trials.