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WHITE PAPERS AND CASE STUDIES

• Operational Success By Strategic Investment

  Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.

• Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing

  Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.

• The Future Of Regulatory Operations

  The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.

• Sickle Cell Cure Within Reach, But At A Steep Cost

  Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.

• 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 Synergy Of Excellence: Partnership During Unprecedented Times

  Learn how a partner with the right experience and capabilities is crucial to support accelerated GMP manufacturing and ensure novel vaccines and therapeutics receive regulatory approval.

• 2024 Global Biopharma Sustainability Review

  What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• Choosing The Right Platform: A Comparison For Regulated Industries

  Regulated industries depend on tightly controlled review workflows, yet common tools rarely meet those demands. Explore how purpose‑built solutions strengthen compliance and help streamline timelines.

• Supplier Quality And The True Cost Of Recalls

  Recalls can cost millions (or even billions) and threaten a company’s public perception. Discover how to minimize recall costs and enhance compliance with effective quality management strategies.

• AI Implementation To Enhance Quality

  Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.

• Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities

  Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.