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| Overcome Early Development Challenges Before They Impact Your Program | The transition from lead candidate selection to clinical development presents risks, including poor manufacturability, low expression, product quality inconsistencies, and immunogenicity. These challenges can cause costly delays, process re-engineering, and reduced investor confidence. Proactively assessing developability, cell line and vector design, expression, product quality, and immunosafety helps identify vulnerabilities early. Targeted characterization supports informed candidate selection, resolves technical concerns before IND-enabling studies, reduces development risks, and facilitates a smoother, more efficient transition into clinical trials. Learn more. |
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| Getting Bispecific Antibody Release Testing Right | Article | By Dr. Fabio Rossi, Dr. Camila Ortega, and Dr. Erika Kovacs, Abzena | Stable linkers and controlled payload loading reduce clearance risks and support scalable antibody-nucleic acid therapies. |
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| Beyond Compliance: A Strategic Approach To Annex 1 | Article | By Robert Keem, August Bioservices | To align with Annex 1 expectations, sponsors should focus on three key steps: understanding the guidelines, selecting the right partners, and futureproofing their manufacturing strategies. |
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| A Novel Valve Component For Use With Standard Syringe Systems | Article | By Marc Flippe and Sophie Lelias, BD Medical - Pharmaceutical Systems | A novel valve provides dual‑chamber functionality within standard syringes, keeping two liquid drugs separated until injection while reducing development risk through advanced modeling. |
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By Louis Garguilo, Chief Editor, Outsourced Pharma | A CDMO employs accomplished professionals, operates modern facilities, and still frustrates the heck out of you. Accumulated talent and capabilities are impressive, but closer examination reveals the problem lies between the lines of the CDMO’s work demarcations. Instead, you need your CDMO to operate as a constellation of unified skills. Chief Editor Louis Garguilo explores this "holistic pattern of work that forms an interconnected organization, and presents a clear picture of management and culture." | |
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The EU Overhauls Pharma Laws: What You Need To Know | By Maarten Meulenbelt, Sidley Austin LLP | On Sept. 18, the Council of the EU published the almost-final text of a major overhaul of the EU pharmaceutical laws. The final binding text is expected to be published very soon. |
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INDUSTRY INSIGHTS CONTINUED |
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| Excipients For Respiratory Delivery Of Biologics | Article | By Kimberly Shepard, Ph.D., Lonza | With only 105 FDA-approved excipients for nasal and inhalation routes, formulating biologics for respiratory delivery demands precise excipient selection across both liquid and solid dosage forms. |
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| An Approach To Lipase Risk Management In Biologics Development | White Paper | By Kyeyeon Hur, Jimin Kim, Minjeong Lee, et al., Samsung Biologics | Conventional HCP testing cannot confirm whether residual lipases remain enzymatically active. Examine why functional activity data are essential for managing polysorbate-related stability risk. |
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| Raising The Bar For Patient Safety And Product Quality | Article | By Haley Johnson, West Pharmaceutical Services, Inc. | Strengthen patient safety and regulatory compliance with comprehensive endotoxin control strategies designed to support the evolving demands of injectable and advanced pharmaceutical products. |
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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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| Connect With Outsourced Pharma: |
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