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| It’s estimated the global market for ADCs could reach over $20 billion by 2030. Around 70% of ADC projects are outsourced to CDMOs and this trend is likely to continue. With increases in commercial drugs entering the market, CDMOs with plans to support commercial-scale ADC manufacturing should invest in facilities and create processes to handle complex supply chains and ensure efficiency, quality, and safety. This whitepaper addresses the challenges of establishing commercial-scale ADC manufacturing capabilities. |
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By Kieran Falvey, Pharmalliance Consulting Ltd. | It is no longer sufficient to just meet compliance requirements; a proactive, risk-based approach to contamination control is now a differentiating factor that enhances operational efficiency and more. For biotech companies evaluating CDMOs, this shift is critical. | |
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| One Family’s 14-Month Journey To Gene Replacement Therapy | Article | Andelyn Biosciences | One family managed to combine resources and people to get an investigational gene replacement therapy manufactured and approved by the FDA so their daughter could be dosed just 14 months from her diagnosis. |
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| 3 Keys To Success When Planning With Your CMO Partner | Article | Argonaut Manufacturing Services | Once you've identified a CMO partner, how do you ensure success? The secret: planning as early as possible – while your product is still in preclinical or clinical development. |
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| Process Development For Lyophilized Products | White Paper | By Jayasree M. Srinivasan, Ph.D., Simtra BioPharma Solutions | Learn to identify potential product failure points and design robust formulations and processes for lyophilized products backed by solid data. |
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| Delivering Excellence In Every Sterile Injectable | Application Note | Pfizer CentreOne | Learn how partnering with a trusted CMO to navigate the complexities of sterile injectable manufacturing can ensure your life-changing therapies reach patients safely, efficiently, and at the highest quality. |
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| Webinar: Leveraging Integrated DS/DP Manufacturing to Mitigate CMC Risks and Simplify Commercial Supply | Discover how Lonza’s integrated CDMO model unites drug substance and drug product manufacturing to drive efficiency and quality. In this webinar, experts share real-world lessons from complex biologics programs, highlighting streamlined tech transfers, shared quality systems, and cross-functional collaboration. Learn how early alignment and proactive problem-solving accelerate timelines, ensure regulatory readiness, and deliver successful commercial outcomes. Click here to learn more. |
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