Clinical Supply Manufacturing Articles

1. Boosting Pipeline Acceleration With A Strategic Pharma/CDMO Relationship 3/25/2022

   Pharma portfolio managers and CDMOs should seek more strategic modes of working together. By coordinating with each other to change all your development and capacity "red lights" to green, and balancing operational efficiency and flexibility, you can accelerate your pipeline. Here's how.

2. 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.

3. Counting The Steps To Decentralized Personalized Therapy Manufacturing 3/21/2025

   AltruBio's CEO has a rough map of the steps to distributed cell therapy manufacturing. She discusses the path and some of the obstacles we'll need to clear first.

4. Survey Findings: How Are IDMP Readiness Efforts Progressing? 12/13/2024

   ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

5. Deciphering FDA's 7-Step Framework For AI-Driven Decision-Making 2/27/2025

   The draft framework, published in January, aims to ensure that AI systems used in drug development are robust, reliable, and aligned with regulatory expectations.

6. Cell & Gene Therapy Manufacturing: Considerations For Early-Stage Companies 1/17/2025

   Key considerations for early-stage cell and gene therapy companies include whether to develop and manufacture internally vs. externally, locally vs. not, and how to choose a CDMO.

7. The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials 5/12/2025

   Syner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.

8. 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.

9. Designing Highly Agile Bio/Pharma Manufacturing Facilities 4/5/2024

   In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules. 

10. 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.