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WHITE PAPERS AND CASE STUDIES

• Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy

  Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

• Lean Six Sigma Methodology Drives Cost Savings: 2 Success Stories

  Unlock significant lab efficiency and financial gains. See how focused optimization of workflows and asset management led to substantial cost savings and reclaimed six-figure value in consumables.

• Alerion Microbubble Cell Separation System Used For T Cell Negative Selection

  Discover how the Alerion™ Microbubble Cell Separation System outperformed standard magnetic methods in T cell recovery, speed, and scalability — achieving higher cell quality with Akadeum’s innovative microbubble technology.

• 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.

• Generation Of A Contamination Control Strategy

  An unaddressed compliance issue related to contamination control can pose a significant risk to a life sciences organization. This case study details a company's journey toward sustainable compliance.

• Progressing A Cystic Fibrosis Treatment With A Strong Culture Match

  Collaborate with an experienced CMO that combines transparency, expertise, and a shared commitment to help advance complex biologics from preclinical research to clinical success.

• Achieving Excellence In Clinical Research And Quality Management

  Lotus Clinical Research, founded in 2001, leverages regulatory expertise and digitalization to enhance quality, automate processes, and improve compliance in biopharmaceutical clinical trials.

• 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.

• Vibration Compensated OCXOs: Advantages, Disadvantages, And Market Applications

  Electronically compensated and mechanically isolated OCXOs each offer unique benefits for vibration-sensitive applications; choosing the right design depends on size, power, and performance requirements.

• Effective Recruitment Capabilities And Outstanding Customer Service

  Hear from many customers who commend OpenClinica's effective recruitment capabilities, outstanding customer service, and adept problem resolution.

• 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.

• Vial Fogging: Practical Considerations For Vial Selection

  Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.