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WHITE PAPERS AND CASE STUDIES

• Development And Regulation Of Veterinary Monoclonals

  Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.

• 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.

• Guide To Seeding, Expanding, And Harvesting Stem Cells

  Investigate important considerations for working with three different stem cell types: mesenchymal stem/stromal cells, induced pluripotent stem cells, and neural stem cells.

• TOC Reduction For Solar Photovoltaic Plant

  Atlantium Technologies installed UV systems in an Indian solar photovoltaic manufacturing plant to remove impurities from ultrapure water, effectively reducing TOC levels and providing high microbial reduction. Their HOD UV technology has been proven effective in water treatment.

• 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.

• Expanding Translational Research Concepts With Genedata Profiler

  The biopharma industry leverages Genedata Profiler to integrate, curate, and analyze diverse R&D data, enabling collaborative, compliant, and AI-driven translational research to optimize drug development.

• Custom Orthodontic Aligner Manufacturer Ensures Compliance With Tulip

  A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.

• Trial Rescue: Leadership Approach To Propel Clinical Development

  Learn how Halloran's assistance was able to improve a rare disease biotechnology company’s development and operations, communication workflow, and avoid the delay of a gene therapy trial.

• Seamless Onshoring From China-Based CDMO

  Successfully mitigate geopolitical risk and maintain supply continuity. Learn how a large-scale manufacturing process was rapidly requalified in eight months to secure a clinical-stage biologic program.

• Leveraging Single-Use Solutions To Solve Working Cell Bank Challenges

  Discover how custom manifolds enhance allogeneic therapy development from formulation to commercialization by improving process control, scalability, and efficiency.

• Mobile App And Wearable Integration Collects Longitudinal Data

  Get an overview of SISCAPA's utilization of eTechnologies, specifically ePRO, and how their partnership with CDS accurately demonstrates the improvement of data collection and analysis in the biotechnology industry.

• The Role Of Hexapods In High-Precision Machining

  A custom hexapod was introduced at ILA Berlin 2024, enhancing precision in aircraft construction. This 6-DOF system improves contour machining of CFRP components, reducing manufacturing times and costs.