Document Migration

WHITE PAPERS AND CASE STUDIES

• Understanding And Implementing USP <665> For Single-Use Systems

  New expectations for single-use systems require structured risk assessment and extractables testing. As compliance deadlines near, practical guidance aligns science, knowledge, regulatory readiness.

• How The Accelerator™ Drug Development Model Enhances eNPV

  Discover how an integrated CDMO and CRO model can accelerate development timelines, add up to $62.9 million in value, and help you maximize long-term pipeline success with a single, streamlined partner.

• Accelerate Drug Development With Master Protocols

  Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.

• Advancements In Microbial Manufacturing Of Biopharmaceuticals

  Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

• 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.

• Reducing Risk And Timelines In Cell Line Development

  Accelerate your biologic development by adopting faster, more reliable clone selection methods that reduce time and resources while improving the likelihood of identifying stable, high-producing cell lines.

• Viral Disinfectant Efficacy Studies: Key Guiding Factors And Design Elements

  Achieving compliance and safety through Disinfectant Efficacy Studies (DES) is about adhering to regulations and committing to high standards of safety and quality of manufacturing operations.

• Raise The Bar: Setting New Standards For The eCOA Industry

  A paradigm shift may be necessary to increase the adoption of Electronic Clinical Outcome Assessments (eCOA) in clinical research. Explore six pivotal areas where eCOA standards can be improved.

• Make Your Production Sites Adaptable And More Efficient

  Pharma faces mounting complexity and tighter margins, demanding agile, future-ready production. Discover how smart manufacturing enables faster adaptation and continuous therapy availability.

• Scaling With The Client In Mind: A Customer-Centric Approach To Project Scale-Up

  In today’s fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise. See how collaboration can transform scale-up and drive confident progress

• How Digitized Protocols Are Accelerating Clinical Research

  Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.

• PV Solutions Optimizing End-To-End Safety In Clinical Development

  Explore what the future of PV services and technology in the life sciences industry could look like if innovation, regulatory vigilance, and collaboration with regulatory bodies were prioritized.