mAbs drug features and key challenges
Key challenges include:
Stability, potency, and safety of drugs over time
Right first time development
Reliable delivery systems to improve therapy adherence
Higher concentration and injection volume
Markets
The biologics market is projected to grow at a double-digit compound annual growth rate of 15% until 2027[1], driven by the increasing adoption of advanced therapies such as monoclonal antibodies. As mAbs and other biologics become more complex, pharmaceutical companies need solutions that help protect drug stability, support reliable delivery, and reduce development risks.
Stevanato Group supports mAbs therapies with integrated solutions across the pharma value chain, combining:
Together, these capabilities help pharmaceutical companies address the specific challenges of monoclonal antibodies, from early development to commercial manufacturing.
[1] Source: IQVIA and Stevanato Group internal analysis
Monoclonal antibody formulations can be highly sensitive and, in some cases, highly concentrated. This makes them more exposed to potential drug-container interactions and requires careful evaluation of both primary packaging performance and delivery device functionality.
Key challenges include:
Stability, potency, and safety of drugs over time
Right first time development
Reliable delivery systems to improve therapy adherence
Higher concentration and injection volume
Stevanato Group is positioned to support mAbs production processes with comprehensive solutions covering the full pharma value chain. By combining drug containment expertise, analytical testing, device know-how, and manufacturing technologies, Stevanato Group helps customers address the specific requirements of sensitive biologic drugs.
Discover Stevanato Group solutions designed to support monoclonal antibodies and other sensitive biologics, from ready-to-use containment systems to analytical testing and advanced delivery technologies.
Our Technology Excellence Centers (TEC) manages customer requests throughout the design and development process by providing phase-appropriate testing for containers and devices.
Breakthrough platform offering minimized subvisible particles and superior gliding performance throughout shelf life
A ready-to-use (RTU) platform designed to reduce complexity and increase quality in pharma fill and finish operations
Designed for optimizing the fill and finish process and the performance with drug delivery systems
2-step, single use auto-injector accommodating both 1mL and 2.25 mL prefilled glass syringes in the same base device.
A pre-filled and pre-loaded on-body delivery system platform suitable for a wide range of therapies