Regulatory Affairs White Papers & Case Studies

1. Cell Line Development For High-Titer Lentivirus Vector Production 3/21/2024

   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.

2. How Vanguard Clinical Harnesses CDMS/EDC For Faster Results 2/6/2024

   Uncover how this CRO was able to stay agile by choosing a CDMS/EDC partner that prioritized sponsor needs and streamlined operations to achieve top-tier results swiftly.

3. Transferring From Microfluidics To A Turbulent Mixer 4/18/2024

   What solutions did the client featured in this case study find when they sought help in transferring their formulation process to a turbulent Impinged Jet Mixing (IJM)?

4. Manufacturing Transfers: Delivering 140+ Precision Medical Devices Without Missing A Deadline 7/11/2024

   Go inside a successful manufacturing transfer of over 140 Class-III silicone medical devices and on-time delivery for a top-30 OEM through expert project management and rigorous validation processes.

5. Innovative Measurement Technology Enables Next Level Industrial AM 10/15/2024

   Reichenbacher Hamuel uses Ophir’s BeamPeek system to enhance laser quality in additive manufacturing, ensuring optimal beam performance and reliability across development, maintenance, and troubleshooting stages.

6. Enhancing Water Quality For Mountaire Farms 5/28/2024

   Mountaire Farms resolved their wastewater facility issues by replacing mechanical surface aerators with SDOX technology, saving $38 million and improving treatment.

7. Improving Patient Health And Safety: SOPs And Process Mapping 10/21/2024

   In this study, a biotech company faced compliance challenges due to inadequate SOPs that lacked detailed process maps. Propharma stepped in to provide a strategy and project plan.

8. Bringing A Device From Concept To Market 8/2/2024

   Within three years, see how this company was able to achieve FDA approval and CE Marking, facilitating its entry into the U.S. and EU markets.

9. Keeping The Lights On With Wolfspeed SiC 10/9/2024

   Introducing the “M” inverter, a modular, silicon carbide-based solution that optimizes utility-scale energy storage with higher efficiency, reliability, and scalability.

10. Leveraging High-Pressure Sterile Filtration For Highly Viscous Solutions 8/26/2024

    This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.