Featured Editorial
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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.
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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.
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How Lumen Is Putting The "Farm" In Biopharma
7/31/2025
Lumen Bioscience's SVP of production and development, Craig Behnke, Ph.D., explains how the company is cutting costs and rethinking upstream manufacturing with its algae-based production platform.
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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.
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5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution
7/29/2025
Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.
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The Safety Potential Of Conditionally Active Biologics
7/28/2025
Conditionally active biologics (CABs) are an emerging class of therapies that can reduce off-target toxicity in the clinic, and they were a topic of conversation at the 2025 BIO International Convention.
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CDMOs Should Stop Stringing Biotechs Along
7/28/2025
Biotechs, first working closely with a CDMO’s sales manager, experience subsequent and sudden rejections of their projects. Did some of you just wince? If so, that might be because we are again hearing of a problem with sudden rejections after protracted discussions and even site visits. Part two on what is one of the biggest problems for outsourcing today.
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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.
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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.
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AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies
7/23/2025
A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.