ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

• Quality Assured: Bringing Life-Changing Therapies To Patients

  Biopharmaceutical drug development remains a key trend, demanding specific expertise and capabilities when it comes to quality assurance. Explore four trends that matter in biologics for clinical trial supply.

• Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

  The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

• Leveraging A Demand-Led Clinical Supply Model For Program-Level Product Pooling

  See how a global biopharmaceutical company was able to address inefficiencies and reduce waste within the clinical supply chain for a high-value therapy that faced strong demand but limited supply.

• Case Management Accelerates Shipment For SCN1A+ Dravet Syndrome Gene Therapy

  Consider this streamlined, end-to-end solution that helped safeguard study timelines and ensured that patients with urgent medical needs could receive treatment without delay.

• Understanding Injectable Drug Container Closure Systems

  Choosing the right container closure system (CCS) format is crucial, so understanding the different parts involved, their functions, storage requirements, and how they impact administering the drug is essential.

• Creating Accurate, Efficient, And Effective CDMO Project Proposals

  To receive the most comprehensive project proposal possible, it is important to fill out any questionnaire as accurately and completely as possible.

• A Supply Chain Management Solution Designed for Clinical Research

  In this use case, follow along the clinical supplies management journey to learn how GxP Inventory replaces fragmented, spreadsheet-based processes to optimize visibility, traceability, and compliance.

• Bringing A Biosimilar For Oncology To Market: Injectable Packaging From Early Development To Commercialization

  While in their early-stage development of a mAb biosimilar for oncology treatment, a large biopharmaceuticals company sought a packaging recommendation: a stopper to maintain high-quality standards.

• Writing Effective Clinical Regulatory Documents For Therapy Trials

  Clinical medical writing for gene therapy regulatory documents is a demanding, detail-oriented task that diverges significantly from medical writing for more traditional therapies.

• The Dual Sourcing Approach

  Having a secondary supplier in place for the manufacturing and packaging of life-saving critical medicines should be an essential part of your strategy in terms of patient health.