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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.

• OEE And Product Inspection

  Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.

• Organizational Assessment For A Large MedTech Company

  Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.

• 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.

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• 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.

• 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.

• 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.

• 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.

• 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.

• Process Development For Lyophilized Products

  Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data.

• 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.