Guest Columns

1. AI Meets CDMO: Smarter Outsourcing For Biologics And Cell And Gene Therapies 8/8/2025

   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.

2. Inside Arbor Biotech's In Vivo Gene Therapy Approach 8/6/2025

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

3. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

   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.

4. Minimizing The Impact Of Human Errors Using Relational Risk Analysis 8/4/2025

   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.

5. Trends And Benefits Of Lean Manufacturing In Pharmaceutical Injectable Facilities 8/4/2025

   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.

6. The Building Blocks Of A Robust Analytical Assay 8/1/2025

   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.

7. Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities 8/1/2025

   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.

8. FDA Priority Voucher Program Submissions Window Opens On New Website 7/29/2025

   The Commissioner's National Priority Voucher program is accepting applications. Experts predict brisk competition since the agency is only awarding five vouchers for now.

9. Outsourced, In-House, Or A Combo: An Agile Recruiting Strategy Fuels Growth In Pharmas And Biotechs 7/28/2025

   There are different staffing options for building an agile and scalable team that can quickly react to shifting needs, resources, and funding.

10. 5 Best Practices For Improving AI Literacy In A GxP Environment 7/25/2025

    ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.