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WHITE PAPERS AND CASE STUDIES

• Comprehensive Pathway To Seamless Scale-Up Of mRNA DP Manufacturing

  An integrated approach to mRNA drug product manufacturing helps to accelerate drug development, mitigate risks, and ultimately deliver life-changing therapies to patients.

• Development And Optimization Of Suspension-Adapted 293T Cell Line

  Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.

• Achieving Licensing For A Healthcare Solution

  Facing strict regulations and tricky powders, a healthcare client sought an advanced filling solution. Learn how an expert collaboration led to licensed product, boosting precision and productivity.

• Tackling Product Quality And Safety Issues Through Global Collaboration

  How the development and execution of a tiered support system, and its results, positively impacted this global collaboration on capacity, efficiency, and cost management.

• Expanding CDMO Advanced Therapy Manufacturing Capability With BSL-2LS cGMP Facility

  See how one manufacturer expanded its production capacity with a modular BSL-2LS cGMP facility built to meet evolving CDMO needs while ensuring robust engineering controls and flexible design.

• Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap

  As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.

• How Sharp Packaging's Clinical Packaging Process Is 30% Faster

  Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.

• Disinfection For Pseudomonas spp. Elimination At Galbani Dairy, Italy

  At Galbani, one of Italy’s premier dairy producers known for its fresh mozzarella, controlling microbial contamination is essential to preserving product quality and shelf life. Pseudomonas spp., notorious for thriving in moist environments and resisting chlorine, posed a persistent threat across their production lines in Corteolona and Casale Cremasco.

• 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.

• Compliance Auditing: Diving Into Common Critical Findings

  Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.

• Leading European CDMO For Drug Product Manufacturing

  As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.

• 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.