Contributing Editors
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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.
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April 2025 — CDMO Opportunities And Threats Report
5/8/2025
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.
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A Road Map For PAT Monitoring And Control
5/8/2025
Process analytic technology monitoring and control is rapidly progressing. BioPhorum shares new best practices on how to move from concept through life cycle management and/or regulatory approval of the PAT application.
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From Preparation To Compliance: DSCSA Implementation Takes Big Steps In 2025
5/7/2025
The phased exemption periods of the Drug Supply Chain Security Act (DSCSA) expire on different dates throughout 2025 (including one quickly approaching in May), marking a series of milestones for implementation.
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Addressing Human "Error" In Pharma Manufacturing
5/7/2025
Why is it that managers at pharma manufacturing sites continue to be frustrated by what could be labeled as “avoidable” human errors, and what can companies do about it? Let's investigate.
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Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis
5/6/2025
Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.
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Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis
5/5/2025
Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.
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8 Ways To Drive Resilience In Oncology Drug Supply Chains
5/2/2025
From traditional chemotherapy to advanced immunotherapies and nanotechnology, pharma/biotech companies must overcome logistical hurdles that affect their oncology products' availability and quality.
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Using Virtual Reality To Enhance Aseptic Contamination Control
5/1/2025
Technologies such as virtual reality (VR), augmented reality (AR), or mixed reality can help alleviate some of the long-standing issues in aseptic contamination control. Here's how.
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Lean Thinking For Pharma — Flow Without Facility Upheaval
4/28/2025
Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.