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WHITE PAPERS AND CASE STUDIES

• Mobile Advanced Therapies Facility

  Discover NIH's innovative solution to clinical-stage viral vector production: See how two mobile cGMP facilities deliver adaptability and compliance to Bethesda's National Institute of Health.

• Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT

  This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.

• Rapid Results In A High-Stakes Dry Eye Disease Trial

  This time-sensitive Phase 3 trial in dry eye disease required precision project management leveraging strong site relationships, ophthalmology-specific expertise, and data-driven site selection.

• How Early-Stage Planning Strategies Are Optimizing Drug Development

  Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.

• A Scalable Single-Use Two-Step pDNA Purification Process

  Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.

• Revolutionizing Pharmaceutical Quality Control

  Learn about a South Korean pharmaceutical company's QC laboratory and how the operation of its chromatography systems has been transformed by implementing a real-time monitoring system.

• Office Of Naval Research Contract Leads To New Chlorine Sensor Technology

  Developed from U.S. Office of Naval Research requirements, this multiparameter chlorine sensor offers extended maintenance-free operation, flow-independence, and automatic compensation for reliable, in-pipe monitoring.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• Expand Bandwidth With A Trusted Regulatory Writing Partner

  Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

• Achieve Higher Targeted Concentrations

  Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.

• 82 Million Gallons In. Zero PFAS Out.

  Ion exchange resin is a reliable, high-capacity solution for municipal PFAS treatment, demonstrating zero detectable PFAS after processing 82 million gallons of water. The technology offers a significantly smaller footprint and superior volumetric capacity compared to GAC. Read the full case study to review performance data and strategic impacts.