Featured Bioprocessing Editorial
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Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies
11/25/2024
The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.
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Is The BIOSECURE Act The First Real Step Toward Reshoring?
11/22/2024
The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?
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Research Explores Alternative To EU-Banned Triton X-100
11/20/2024
One of the best-known viral inactivation agents is now banned in the EU. A group of scientists explored Virodex TXR-1 as a suitable alternative. Here's what they found.
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Defining When To Implement Technologies To Support Commercial Growth
11/20/2024
Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.
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Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
11/19/2024
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides
11/18/2024
Developing a practical chemistry, manufacturing, and controls (CMC) strategy for oligonucleotides and peptides demands a shift in approach in terms of the way you collaborate with your CDMO.
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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Confused about FDA's draft guidance on potency assays for cell and gene therapy products?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.