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WHITE PAPERS AND CASE STUDIES

• CRO Collaboration That Fuels Innovation For Specialty Biotechs

  Delve into the advantages of specialty CRO collaborations and the strategic opportunities that lie ahead as the life sciences field continues to embrace innovation and collaboration.

• 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.

• Streamlining Study Start-Up For Accelerated Drug Development

  What is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.

• 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.

• 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.

• 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.

• 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.

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• 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.

• Pasteurized Equivalent Water Treatment At Tnuva Ba'Emek, Israel

  In the heart of Israel’s Jezreel Valley, Ba’emek Advanced Technologies—part of the Tnuva Group—faced a critical challenge: how to sustainably reuse water extracted from whey during dairy processing without compromising safety or quality.

• Symmetry Surgical Uses Software To Enhance Quality

  Symmetry Surgical enhances operations and quality management using software to improve efficiency, compliance, and data-driven decisions while producing over 2 million surgical devices annually.

• Keeping The Lights On With Wolfspeed SiC

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