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WHITE PAPERS AND CASE STUDIES

• AAV-Based Gene Editing For Huntington's Disease

  LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• Breaking Barriers In Malaria Prevention With A Mobile Cleanroom

  The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

• MBR Solutions For Modern Industries

  This white paper will explore advanced, sustainable wastewater management systems that align with your business's growth trajectories and emergent needs. 

• 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.

• 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.

• Tailored Approach Supports Bladder Cancer Breakthrough

  Discover how a flexible operational strategy and expert site management help bladder cancer programs overcome complex logistical hurdles and achieve critical regulatory milestones.

• Membrane Adsorber Chromatography In Oligo-mAb Conjugation

  Discover how the team was able to expedite the conjugation of an oligonucleotide-monoclonal antibody (oligo-mAb) program leveraging experience in chromatography.

• Support Digital Transformation And Enable Collaboration Between Teams

  Discover the solution PharmaEssentia, a Taiwanese pharmaceutical company, chose to help teams capture, structure, and interrogate data from a single source, making their collaboration more efficient.

• 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.

• Bringing Clinical Testing To New Heights In New Jersey

  Explore how clinical testing was transformed with a pioneering BSL-2 mobile laboratory on a Sprinter Van platform to enhance safety and portability for advanced biosafety requirements.

• Bispecific Antibodies Unleashed

  Explore how leveraging expert CDMO partnerships can streamline the development process and enhance the efficacy of your bispecific antibody therapies.