Outsourced Pharma Newsletter | December 22, 2025 | View web version here. |
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Meeting Annex 1: A Proactive Approach To Regulatory Compliance | Case Study | By Victoria Morgan, West Pharmaceutical Services, Inc. | It was imperative for a large European CMO producing multiple biologics to select the right product quality and value for each customer to comply with the August 2023 EU GMP Annex 1 revision. |
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By Jeffrey S. Buguliskis, Ph.D., deputy chief editor, Outsourced Pharma | By replacing trial-and-error with virtual simulations and predictive analytics, AI is giving even small biotechs the process development capabilities once reserved for Big Pharma — and slashing tech transfer timelines in the process. | |
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The Promise And Paradox Of QbD | By Irwin Hirsh, Q-Specialists AB | The difference between QbD as burden and QbD as advantage lies in critical thinking supported by structure — a hierarchy of metrics, toolsets, and tailored platforms. |
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INDUSTRY INSIGHTS CONTINUED |
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High-Throughput Formulation Development For High-Concentration mAbs | Poster | By Jessica Ripley, Shyamal Choudhari, Lun Xin, Spencer Beard, Victor Vinci, and Yunsong Li | See how a high-throughput microwell plate platform economically screens a model IgG1 mAb at 120 mg/ml across 96 formulations while minimizing protein use and maximizing data output. |
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Partners For The Planet: Sustainability Review | e-book | FUJIFILM Biotechnologies | In this report, we review concrete examples of projects across a global network that are contributing to the successful achievement of sustainability goals and aspirations. |
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How Does A CMO Define Legacies? | Infographic | Pfizer CentreOne | Partner with a CMO that combines expertise, innovation, and trusted global capabilities to bring life-changing therapies to patients faster and more reliably. |
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Factors Which Impact mAb Process Scale-Up | Cytiva | Thinking about your mAb scale-up processes early on can help avoid common pitfalls. Cytiva’s Fast Trak scientists discuss factors that can influence a successful scale-up outcome. |
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Leveraging Advanced Technology And Proven Expertise | Catalent | By leveraging our proprietary non-viral gene insertion technology, GPEx® Lightning ensures rapid development timelines and high-yield production, making it an ideal solution for complex biologics. |
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Capabilities Update October 2025: Analytical Services | Mabion | We offer an end-to-end solution, covering every stage of biologic drug development, from early clone selection and small-scale manufacturing to process scale-up, large-scale production, and quality control. |
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Self-Administered Disposable Autoinjector | BD Medical - Pharmaceutical Systems | BD Physioject Disposable Autoinjector offers a proven, user-friendly platform for self-injection, enhancing patient comfort, safety, and adherence across multiple chronic disease treatments globally. |
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OUTSOURCED PHARMA CAPABILITIES UPDATE |
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CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs. |
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