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WHITE PAPERS AND CASE STUDIES

• Scale Up Strategy For Oncolytic HSV-1 Vector Manufacturing

  Discover how a novel, large-scale production method for herpes simplex virus type-1 vectors has the potential to accelerate the progress of gene therapy and bring it closer to widespread application.

• RO Membranes' Protection At Pinghu Power Plant, China

  A power plant in Pinghu, Zhejiang Province in China needed to replace the use of chemical biocides and protect boiler feed make-up water from anaerobic and aerobic bacterial growth and associated biofouling.

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• How A Global Pharma Manufacturer Reduced Line Stops And Increased OEE

  Gain insight into how a leading pharmaceutical company identified the root cause of long-standing inefficiencies, optimized performance, and productivity with unprecedented speed and accuracy.

• How To Unlock The Secret To Repeatable, Scalable Low Turnover

  Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.

• 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.

• Extractables And Leachables Assessment For Single-Use Systems

  Efforts to enhance biopharmaceutical manufacturing focus on boosting production capacity sustainably and economically. Explore how optimizing processes with single-use solutions and monitoring leachables ensures product quality.

• Leveraging High-Pressure Sterile Filtration For Highly Viscous Solutions

  This research demonstrates the potential of high-pressure sterile filtration to enhance efficiency, reduce waste, and accelerate the development of innovative therapies.

• Facility-Fit-Driven Process Development For A Monoclonal Antibody

  See how proactively designing around plant constraints, using high-capacity resins, and leveraging parallel workstreams resulted in a 50% reduction in processing hours and 25% lower costs.

• Advancing Multiomics Through Intelligent Automation

  Modern automation tackles hidden pipetting errors and boosts reproducibility. Discover how your lab can scale confidently, reduce rework, and accelerate multiomic workflows with built-in traceability.

• Accelerating Approval Pathway For Phase III Ovarian Cancer Trial

  A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.

• Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes

  The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.