Clinical Supply Manufacturing Recources

31. Addressing Rare Disease Drug Product Manufacturing Challenges 2/22/2023

    Handling development and manufacturing challenges for orphan drugs requires experience, expertise and scalable technologies, along with a flexible and agile supply chain.

32. A Supply Chain Management Solution Designed for Clinical Research 8/4/2023

    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.

33. Optimizing Autologous Cell Therapy Clinical Trials 11/6/2023

    Delve into four articles regarding dissecting the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.

34. De-Risking Your Bioconjugate's Path To Clinical Manufacturing 9/30/2022

    Explore the challenges when moving a bioconjugate candidate from early development to clinic, along with integrated solutions for navigating this growing area of the biopharmaceutical industry.

35. Delivering Apheresis Treatment From The USA To The UK Within 24 Hours 3/21/2023

    The goal was to perform next-day collection of temperature-sensitive tumor material for an urgent patient treatment. A flexible mitigation strategy was essential to manage short turnaround.

36. Overcoming Challenges In Cell And Gene Therapy Containment

    Review the hurdles that can slow your time to market, including the challenges in packaging high-value therapies and solutions to help you mitigate risk and simplify the journey.

37. Functional Testing Summary Of Daikyo Crystal Zenith Nested Vials 5/24/2024

    The Daikyo Crystal Zenith nested vials meet the exterior dimensions of the glass standard ISO 8362-1. The vials maintain CCI for up to 6 months and can withstand ultra-cold temperatures and drop conditions.

38. Developing Injectable Drug Placebo Formulations For Clinical Trials 1/9/2024

    Developing a placebo for an injectable drug requires consideration of the formulation’s impact in trials, chemistry and physical details, ethical concerns, and regulatory compliance.

39. Speed To Market – API Large-Scale Commercial Manufacturing 1/20/2022

    Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

40. Integrating Early-Phase Clinical Supply Manufacturing & Distribution 5/10/2022

    A tablet formulation was a solution when developing a new class of anti-infective medicine, allowing the integration of formulation development, clinical trial material (CTM) manufacturing, and supply and distribution to patients.