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WHITE PAPERS AND CASE STUDIES

• Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals

  VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

• Disinfection For Purified Water Loop For Kamada Pharmaceuticals, Israel

  An Atlantium HOD™ (Hydro-Optic Disinfection) UV system was installed at the outlet of a PW tank to serve as the primary disinfection barrier, with water circulating through the system at 6m³/hr before reaching the points of use.

• Successful Cell-Based ADA Collaboration In mRNA Gene Replacement Therapy

  A biotech firm developed a rapid, sensitive, cell-based ADA assay through collaborative innovation, reducing variability and turnaround time while improving performance for mRNA gene therapy.

• Collaborative Variability Reduction In Cell Culture Media

  Variability reduction programs improve biomanufacturing by controlling raw‑material complexity, optimizing critical attributes, and boosting productivity through data‑driven partnerships.

• Writing An IND Module 3 For Cell And Gene Therapy Products

  This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.

• 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.

• What Made The Becancour Water Treatment Plant A Model For Clean Water Solutions?

  Learn how Quebec’s Becancour Water Treatment Plant improved ozone efficiency, reduced maintenance, and enhanced scalability by upgrading to a modular Pinnacle Summit ozone system.

• How To Get Products To Patients Faster With A Connected QMS

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• Life Sciences Corporation Implements eLogbooks Across 15 Sites

  New regulations challenged how surgical kits were tracked and processed across 15 U.S. sites. Discover how one team balanced compliance and efficiency to keep life-saving procedures on schedule.

• 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.

• RO Membranes' Protection At SWRO Facility, Asia

  Atlantium HOD UV systems provide effective RO membrane protection by combining ultraviolet water disinfection technology with hydraulic and optic principles.

• Physiologix™ Serum Replacement Performance On Mesenchymal Stem Cells

  Learn about the effectiveness of a xeno-free serum replacement in mesenchymal stem cell (MSC) culture and its potential to enhance cell growth and reduce variability compared to fetal bovine serum.