CELL & GENE ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Understanding Immunogenicity In AAV Gene Therapy

  As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.

• De-Risk Nucleic Acid Therapeutics Through Strategic Outsourcing

  Bringing a nucleic acid therapy to market requires specialized formulation and development knowledge. Innovators need rigorous analytical and formulation strategies to achieve stability and quality.

• Filling Syringes With Spray-Dried Powders - The How, The Why And The Benefits

  Discover how filling spray-dried powders directly into syringes improves stability, minimizes cold chain reliance, and accelerates administration speeds for critical therapies.

• Delivering Specialist Neurology Support

  Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.

• Advancing Dose Escalation Strategies With Bayesian Modeling

  A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.

• Successful Partnership Advances AML Program To Phase II/III

  See how strong collaboration rescued a stalled AML study, proved a safer approach to a proven drug class, and turned a Phase I/II partnership into a global Phase II/III trial.

• Delivering Critical Therapies With Speed And Safety

  Faster approvals depend on treating regulation as part of development, not the finish line. See how early quality planning and strong agency communication can move therapies toward patients sooner.

• Scale-Up Of AAV Production In Fixed-Bed Bioreactors

  Consistent AAV production is critical for manufacturing. See how aligned strategies deliver comparable cell growth, metabolic trends, and rAAV5 titers from development through production.

• Confirming Structural Consistency With HDX-MS

  To support regulatory confidence, a biopharma company evaluated whether manufacturing changes affected its monoclonal antibody's higher-order structure.

• Where Speed Meets Complexity In Bioprocess Development

  Bioprocessing faces mounting pressure to compress timelines, especially for mAbs, while complex modalities like bispecifics and gene therapies introduce technical challenges. Process intensification, scale-up translation, and comparability risks remain critical hurdles.