Guest Columns
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UK To Implement Novel Framework For Point-Of-Care Manufacturing
11/14/2024
It will be the first country to introduce a tailored framework for innovative medicine manufacturers at or close to where patients receive care.
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Considerations For Potency Assurance Of CGT Products
11/12/2024
Confused about FDA's draft guidance on potency assays for cell and gene therapy products? Let's clarify a few things and discuss some key considerations.
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3 Focus Areas To Transition From Clinical To Commercial Readiness
11/12/2024
Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas.
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October 2024 — CDMO Opportunities And Threats Report
11/11/2024
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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CDMO Selection: 7 Steps To Find Your Best Fit
11/11/2024
Selecting the right CDMO for your project is essential. Here is a practical 7-step process, along with key considerations and pitfalls to avoid along the way.
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A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS
11/8/2024
How do the principles of filter integrity testing described in EudraLex Annex 1 apply to low bioburden drug substance manufacturing? And how can using a risk-based approach help?
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The Complex Regulatory Landscape Of Flow Cytometry For Cell Therapy
11/8/2024
Flow experiments must be controlled to produce consistent data. With a gush of new technology, regulators have put more scrutiny on flow cytometry-based approaches.
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Commissioning & Qualifying: Facility Considerations For Tissue Engineering
11/7/2024
This article provides an overview of the facility considerations for tissue engineering. It includes a comparison of a bulk biologics facility, which aids the discussion.
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Biopharmaceutical Fermentation Systems' Growing Role In Modern Medicine
11/6/2024
Bioreactors, culture media, growth factors, and sensors are essential to foster microbial or cell growth in optimal conditions.
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How Ring's Single-Capsid Protein Approach Optimizes Viral Delivery
11/5/2024
Complexity and manufacturability have an inverse relationship. Ring’s platform seeks to simplify highly complex gene therapy production by making the most of biology.