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WHITE PAPERS AND CASE STUDIES

• Digital Standardization: Accelerating Gene Therapy Tech Transfer With Confidence And Compliance

  Fragmented, manual data practices slow tech transfer and increase risk; centralized digital CMC systems standardize workflows, improve transparency, and accelerate onboarding while maintaining compliance.

• Can Your Biopharma Team Keep Unplanned Downtime At Bay?

  Learn how teams reduce downtime, strengthen compliance, and respond quickly to equipment issues through proactive maintenance, smart spare parts planning, and digital troubleshooting tools.

• OEE And Product Inspection

  Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.

• Modular Automation: The Plug-And-Produce Opportunity For Life Sciences

  Explore how the advantages of modular automation in life sciences emphasize flexibility, efficiency, and cost savings through plug-and-produce systems that enhance production adaptability and speed.

• 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.

• From CLD To CDMO: Demonstrating A Successful Cell Line Technology Transfer

  Explore critical considerations for biopharmaceutical developers and CDMOs during technology transfer as well as a successful transfer and scale-up of a cell line from a CLD platform to a global CDMO.

• Futureproofing Post-Approval Compliance

  In the post-approval stage, a synergistic operating model brings PV and regulatory functions under one umbrella: a single governance structure with shared decision cycles, templates, and evidence.

• Sustainable Solutions For Medical Devices

  Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.

• Biometric Services For Large Pharmaceutical Company

  This case exemplifies the effectiveness of flexible staffing solutions in meeting the dynamic needs of the biopharmaceutical industry while maintaining control over project deliverables and timelines.

• Food Safety Digital Maturity In The Supply Chain

  Look at how connected data and automated processes strengthen safety, improve traceability, and streamline compliance across the supply chain—offering a clear roadmap for progression.

• 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.

• Patented Process For Intermediates Useful For Etrasimod Arginine

  Explore how rethinking the synthetic strategy for Etrasimod can overcome the limitations of legacy routes, enabling more efficient chirality control, improved scalability, and more practical industrial API production.