Industry Insights

31. Understanding The FDA's Current Focus On Risk Evaluation And Mitigation Strategies 9/21/2023

    The FDA recently asked for comments about how the government handles vendor change requests from drug sponsors with risk evaluation and mitigation strategies. So, we asked a REMS expert to help us understand why the agency is focusing on the broad-reaching program and what it could mean for drug manufacturers with REMS products in their portfolios.

32. How To Overcome Bioprocess Development Challenges 4/12/2022

    We explain how to successfully address common process development challenges to achieve an efficient journey to market and maximize the biotherapeutic’s potential impact.

33. Agile Software Development In Bio/Pharma & Medical Devices, Part 2 7/11/2023

    Part 1 of this article series dived into the use of Agile methodology with a focus on the planning phase of a software development plan. This article dives further and discusses the phases of team structure and collaboration, defining requirements and product definition, software architecture, and more.

34. Calculating Process Capability Of Cleaning Processes With Completely Censored Data 10/31/2022

    Data below the detection limit (DL) are known as left-censored data. Quite often, 100% of the results of the cleaning samples fall below the DL. How can cleaning process capability be calculated in such situations? This article explores several approaches.

35. Developing An Effective Lipid Nanoparticle Formulation Process For Small Molecule And Biologicals Delivery 3/1/2022

    Lipid nanoparticles (LNPs) are a versatile formulation technology used by drug development teams to deliver a variety of small/large molecules, peptides, and biologicals.

36. From Setup To Sign-Off: Managing Simultaneous Reviews In Veeva Vault 7/9/2025

    Collaborate on complex documents with ease with an integrative platform that empowers high-volume teams to streamline workflows, boost compliance, and accelerate reviews within a secure environment.

37. Applying Automation To The Manufacture Of Drug Delivery Devices 7/12/2023

    Automated manufacturing is a powerful but often misunderstood tool available to produce drug delivery and other pharmaceutical devices — whether established designs or innovative new ideas.

38. 25 Years Of VST Therapies: The Journey Behind The Technology And Innovation 10/19/2021

    This article explains the major stepping stones to preventing and treating serious viral infections in high-risk populations with T cell deficiencies.

39. Key Considerations For Selecting Flexible Fillers

    Flexible fillers are beneficial to drug developers looking for lifecycle management of their drug products. Explore key considerations for selecting flexible fill/finish manufacturing technologies.

40. Aseptic Extrusion: Preventing Contamination And Ensuring Product Sterility 6/12/2025

    Discover the critical process considerations and custom engineering required to handle temperature-sensitive and high-viscosity pharmaceutical materials.