RFICs

WHITE PAPERS AND CASE STUDIES

• Navigate The Complexities Of CGTs With Regulatory And CMC Expertise

  Explore how strategic regulatory and CMC expertise helped guide a biopharmaceutical company’s regulatory and development strategy for a cell and gene therapy product.

• Improving Pre-Clinical Study Efficiency With mRNA-LNP Technology

  Uncover how Repair Biotechnologies, in collaboration with Vernal Biosciences, helped to pave the way for the next generation of breakthrough treatments for cholesterol and aging-related diseases.

• Improving Patient Health And Safety

  Engage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.

• Accelerating Early Phase Oncology Study Development

  Explore a close collaboration to co-develop a comprehensive, adaptive protocol designed to support key decisions across multiple trial phases for an innovative cancer therapy.

• Metropolitan Sewer District Of Greater Cincinnati

  The Lower Mill Creek Partial Remedy (LMCPR) in Hamilton County, Ohio, is a large, complex effort to remove about 1.78 billion gallons of combined sewer overflows (CSOs) annually from the Mill Creek, an Ohio River tributary. When complete, LMCPR will improve water quality and serve as a catalyst to improve local neighborhoods.

• End-To-End Inventory Control Supports Biotech's Expanding Portfolio

  Many organizations struggle with siloed operations, but this modern GxP inventory solution solves these challenges by providing a centralized, cloud-based platform for end-to-end visibility.

• Changing The Clinical Feasibility Game With AI

  AI is only as good as the data it’s built upon. Our customized AI platforms are constructed on a foundation of trustworthy, carefully curated data to produce detailed, expert-driven responses.

• Cell Line Development For High-Titer Lentivirus Vector Production

  Explore a groundbreaking method to significantly enhance LV vector yield using engineered HEK293T cells. This approach paves the way for more efficient and large-scale production of LV vectors.

• Secondary Packaging: Inspection, Brite Stock Bottle Labeling, And Cartoning

  Gain insight into a coordinated, around-the-clock approach that demonstrates how packaging efficiency can keep pace with urgent pharmaceutical launches and tight commercialization timelines.

• Drinking Water Disinfection At Lunenberg, Massachusetts, USA Local Community

  In this case study, read how the Lunenburg Water District improved their water disinfection system with the installation of an Atlantium RZ300-11 HOD UV system. The system effectively disinfects water, meets future demands, and eliminates chlorine taste and odor.

• Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research

  By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.

• Reducing The Burden Of Patient Retention And Improving Continuity

  Immunology trials often place a sustained burden on participants. However, integrating Home Trial Support (HTS) into a Phase 3 immunology trial can help improve the overall study experience.