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WHITE PAPERS AND CASE STUDIES

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• Live Biotherapeutic Products: Unique Quality, Manufacturing, And Nonclinical Considerations For Clinical Trial Entry

  Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease.

• Sensing Beyond Limits: Transforming User Experience With UWB Radar

  Ultra-Wideband radar sensing enables low-power, high-precision presence, motion, and vital-sign detection, unlocking smarter automotive, smart-home, and healthcare applications beyond traditional ranging.

• Evaluating Milling Conditions For Scaling Up A Nanosuspension Drug Product

  Aiming to obtain a target particle size to support Phase 3 clinical trials, uncover how this study contributed insights on nanosuspension drug product production at escalated scales.

• 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.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Random And Semi-Targeted Integration In Cell Line Development

  While semi-targeted approaches may offer precision, uncover how they may fall short in overall efficiency and productivity, especially in late-stage manufacturing.

• Methods For Determining Equipment Capability Of Freeze-Dryers

  Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.

• Elevating Diverse Patient Voices To Inspire Clinical Trial Participation

  Explore the innovative approach taken during this clinical trial partnership to address the underrepresentation of minority communities in clinical trials through digital storytelling.

• Scalable Production Of High-Purity Nanobodies Using Yeast Expression System

  Leverage scalable K. pastoris expression systems to produce high-quality nanobodies for cutting-edge therapeutic, diagnostic, and research applications.

• 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.

• Optimizing Upstream Process Development To Increase mAb Titers

  Uncover how we were able to help a client develop an efficient upstream process for a novel monoclonal antibody (mAb), resulting in a more than 100% increase in titers.