Document Migration

WHITE PAPERS AND CASE STUDIES

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• Insights And Effective Strategies For A Successful Technology Transfer

  Discover key strategies for seamless pharmaceutical technology transfers that accelerate time to market, ensure product quality, and meet regulatory standards across the drug lifecycle.

• Validation Provider Shortens The Path To Equipment Qualification

  Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

• Study Start-Up Challenges: Hard Realities, Effective Strategies

  Launching a study is complex, and the time between protocol approval and the first patient visit has increased dramatically. How can companies reverse this trend and accelerate study start-ups?

• A Toolbox For An Effective Tech Transfer

  As drug development costs rise, companies are embracing digital-first strategies and Pharma 4.0 principles to streamline operations, enhance tech transfer, and accelerate time-to-market through innovation.

• Forge Boosts Efficiency And Compliance During External Collaboration

  Streamlined collaboration and unified quality systems are helping CDMOs cut review times. Discover how connected workflows improve compliance and efficiency for faster delivery of life-changing treatments.

• Streamlining ADC Development: Advantage Of An All-In-One Solution

  Antibody-drug conjugate (ADC) development requires tightly integrated manufacturing. Streamlined, end-to-end solutions reduce complexity, improve quality, and accelerate time-to-market.

• Challenges And Solutions In Lyophilization Development For ADCs

  Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.

• Maximize Output From Full-Time Employees

  Learn about project-based insourcing solutions designed to give clients laboratory services support with flexible timeframes, and eliminate worries about co-employment and other regulatory concerns.

• 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.

• A Risk-Based Approach To Plasmid DNA And mRNA Process Development

  Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

• Preparing For Disease X: Effective Vaccine Development In The Face Of A Future Pandemic

  CDMOs are playing a critical role in the global effort to prepare for future pandemics. Learn how innovative strategies and flexible platforms are helping to ensure a swift and effective response plan.