Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• AOC GMP Manufacture For A FIH Study

  Successful development of AOCs for FIH studies requires robust GMP processes and efficient scale-up. A key step is careful management of a multi-day conjugation process with vital in-process checks.

• Compliance with Annex 1: Sterile Fill/Finish for Early Phase Clinical Supplies

  Grasp the strategies for Annex 1 compliance, focusing on Contamination Control Strategy, Pre-Use Post Sterilization Integrity Testing, and critical zone controls to secure aseptic manufacturing processes.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• Optimizing Generative AI In Clinical Operations

  Crafting a thoughtful strategy to determine the optimal utilization of Generative AI in advancing medical research and enhancing patient well-being.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• AqueoUS Vets Named A Manufacturing Partner For A Southern CA Water Treatment Facility

  In August 2018, Aqueous Vets was selected over existing industry incumbents to supply the Granular Activated Carbon Systems (GACS) for a Southern California Water Treatment Plant.

• Designing More Representative Trials Through Strategic Planning

  Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.

• Breaking Barriers In Malaria Prevention With A Mobile Cleanroom

  The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

• The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

  Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

• Bringing Clinical Testing To New Heights In New Jersey

  Explore how clinical testing was transformed with a pioneering BSL-2 mobile laboratory on a Sprinter Van platform to enhance safety and portability for advanced biosafety requirements.

• Advancing In Silico Predictions In Early Drug Discovery

  Examine a high-throughput approach that streamlines LogD measurements, offering faster and more accurate insight into compound lipophilicity to support better decision-making in early drug discovery.

• How A CDMO Gained 40%+ Efficiency By Generating Automated APQRs

  Discover how a CDMO's mounting challenges with manual product quality review (PQR) processes were resolved through the implementation of a next-generation cloud-based solution.