Business Process Outsourcing

WHITE PAPERS AND CASE STUDIES

• 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.

• Earning RMAT Designation - What Developers Need To Know

  Explore a high-level overview of the Regenerative Medicine Advanced Therapy designation and how to ensure success and accelerate advanced therapy products toward commercialization.

• Optimized Stability Storage

  A healthcare manufacturer facing space constraints and regulatory pressures outsourced their stability storage needs to another company, resulting in reduced costs and focus on core competencies.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• An Experienced CDMO Can Be A Differentiator In The Rapidly Growing Biologics Market

  Discover how an experienced CDMO offering a purpose-built facility with flexible capacity can help biopharmaceutical companies bring their products to market quickly and efficiently.

• How Community Oncologists View CAR T-Cell Therapy Possibilities And Challenges

  Learn how a partner with innovative solutions aimed at overcoming the barriers that limit the real-world impact of CAR T-cell therapy can make these advanced therapies more accessible and affordable.

• 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.

• A New Approach To Characterizing Crystalline Structure

  Learn how the accuracy (melting temperature and heat of fusion) and utility of Differential Scanning Calorimetry data is greatly diminished for materials that undergo Apparent Melting and much more.

• Targeting Macular Degeneration With Stem Cell Therapy

  A novel stem-cell therapy based upon iPSC-derived RPE cell transplantation was conceptualized as a promising new treatment for AMD and other retinal diseases.

• IT Changes Implemented To Overcome Future Manufacturing Challenges

  Learn how Pfizer and Ferring improved their reporting and batch information management with Rockwell’s technology.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Patient Diversity: Identifying Challenges, Opportunities, And Best Practices

  By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.