Clinical Supply Manufacturing Articles

51. Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots 10/31/2025

    The terms “confirmatory" and "conformance" batches are inconsistently used in the industry. Since process validation is essential for maintaining compliance and detecting variability, we must work toward harmonization of the terms to avoid confusion.

52. Scaling RNA Production From The Lab To The Clinic 8/9/2024

    Nutcracker's unique approach to scaling up to clinical manufacturing — which brings unique challenges compared to traditional biologics — relies on microfluidics.

53. New DSCSA Compliance Blueprint Includes FDA & Industry Input 4/12/2023

    Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.

54. A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches 11/6/2025

    The transition from 2D to 3D cell culture requires a combination of advanced analytical techniques, but aligning new methods with established principles can be challenging.

55. Digitizing CMC Knowledge Management 4/8/2024

    Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.

56. 10 Ways To Speed Up CMC In Early-Stage Drug Product Development 2/21/2025

    The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies.

57. 7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies 7/3/2025

    The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.

58. ICH Revises Q1 Guideline, Advancing Stability Testing Standards 4/24/2025

    In April 2025, the International Council for Harmonisation (ICH) released draft ICH Q1: Stability Testing of Drug Substances and Drug Products for public consultation. This new draft guideline represents the first major overhaul of global stability testing standards in over two decades.

59. Process Mapping For More Effective Knowledge Management 2/26/2024

    It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.

60. Moving From Clinical Stage To Commercial? 4 Steps For An Outsourcing Strategy 9/18/2023

    If you're a pre-commercial bio/pharma looking ahead to commercial stage, evaluating partnerships are faced with making key decisions around which capabilities to outsource, the degree of data access and ownership, and which external partners are the right fit. Here are four key actions to consider.