Newsletter | June 9, 2026

06.09.26 -- CDMO Capabilities for Biologics And HPAPI Manufacturing

 

 

As therapeutic modalities become increasingly complex, development and manufacturing success depend on access to specialized expertise, advanced technologies, and purpose-built facilities. Whether producing mammalian cell culture–derived biologics or highly potent active pharmaceutical ingredients (HPAPIs), sponsors face unique challenges related to process development, scale-up, quality, containment, regulatory compliance, and commercialization.

 

This edition of the Outsourced Pharma Capabilities Update (OPCU) highlights the capabilities CDMOs bring to complex biologics and potent compound manufacturing, showcasing expertise across cell line development, upstream and downstream processing, GMP production, containment technologies, occupational safety, and process scale-up. Join us to explore the facilities, technical platforms, and manufacturing strategies that help sponsors mitigate risk, accelerate development timelines, and successfully advance innovative therapies from early development through commercial production.

 

Recent Sessions Available On-Demand        
Fill/Finish & Small Molecule – 4/21/2026 & 4/22/2026     

 

Upcoming OPCU Topics & Times

Cell Therapy | 6/16/2026, AM Session        
Cell Line Development | 6/16/2026, PM Session      
Microbial Development & Manufacturing | 6/17/2026, AM Session      
ADCs | 6/17/2026, PM Session   

 

Access more on-demand OPCU recordings and upcoming sessions here.

MAMMALIAN CELL CULTURE

KBI Biopharma

Uncover how advanced cell line development platforms, targeted integration technologies, and data-driven selection tools can accelerate biologics development from DNA to patient with greater speed, stability, and confidence.

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KBI Biopharma

AGC Biologics

Learn how the Multi-Pack system accelerates scale-up, boosts efficiency, and reduces costs. We'll share real-world case studies on streamlining development and commercialization while meeting evolving clinical and market demands.

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AGC Biologics

IDT Biologika

Discover how advanced mammalian cell culture platforms, proven process strategies, and end-to-end CDMO capabilities can accelerate biopharmaceutical development. Learn how scalable manufacturing solutions support high-quality biologics production.

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IDT Biologika

Novartis Contract Manufacturing

Explore a global contract manufacturing network with proven regulatory success, flexible partnership models, and end-to-end capabilities spanning biologics, advanced therapies, and fill-finish to support your program.

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Novartis Contract Manufacturing

FUJIFILM Biotechnologies

Advance your next biologic, vaccine, or advanced therapy with a global CDMO partner offering end-to-end development and manufacturing services. From cell line development to commercial production, we help bring innovative therapies to market.

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FUJIFILM Biotechnologies

HPAPI & API DEVELOPMENT

Curia

What is critical when choosing a CDMO partner for HPAPI development and manufacturing? Curia's Brian Haney breaks down the key questions, containment strategies, controls, and expertise every innovator should evaluate for long-term success.

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Curia

Recipharm

Overcome common high-potency development challenges, reduce API consumption, streamline tech transfer, and accelerate timelines. Discover practical strategies for building scalable, reliable manufacturing processes from day one.

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Recipharm

Ardena

Here, we explain how integrated, science-led CDMO/CRO strategies can manage the full complexity of high-potent drug development — from containment-focused manufacturing and ultra-sensitive analytics to product delivery.

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Ardena

Bend Bioscience

Take a closer look at how expanded capacity, commercial spray drying capabilities, and targeted investments support seamless progression from development to commercial manufacturing while advancing complex drug programs with confidence.

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Bend Bioscience