GUEST COLUMNISTS

• July 2025 — CDMO Opportunities And Threats Report

  Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

• AI Meets CDMO: Smarter Outsourcing For Biologics And Cell And Gene Therapies

  Vadim Klyushnichenko, Outsourced Pharma Board member and VP at California Institute for Biomedical Research (Calibr), continues his detailed discussion of utilizing AI at CDMOs to improve the outcomes for both sponsors and external service providers.

• Inside Arbor Biotech's In Vivo Gene Therapy Approach

  Following recent news about first-in-human testing, two executives discuss the science and manufacturing strategy for the company's lead candidate, ABO-101.

• EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance

  The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

• Minimizing The Impact Of Human Errors Using Relational Risk Analysis

  This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.

• Trends And Benefits Of Lean Manufacturing In Pharmaceutical Injectable Facilities

  The pharmaceutical injectable manufacturing sector is experiencing unprecedented transformation through lean manufacturing adoption. This analysis examines current implementation trends, productivity impacts, and quality integration strategies based on data from leading pharmaceutical organizations.

• The Building Blocks Of A Robust Analytical Assay

  Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

• Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities

  In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.