For biotech companies, scaling from early discovery to commercial manufacturing is a multi-step process that presents significant challenges. From process development and tech transfer to regulatory planning and large-scale production, each stage introduces its own risks and roadblocks. Having the right contract development and manufacturing (CDMO) partner can make the difference between a streamlined path to market and costly delays. This blog explores how an effective CDMO partnership supports biotech innovators at every step of this transition, combining scientific rigor, digital tools and a flexible mindset to scale production efficiently while maintaining the highest quality standards.
Building continuity and confidence into scale-up
One of the most common pain points during scale-up is the disconnect between laboratory-scale development and full GMP manufacturing. Different equipment, workflows and teams can cause inconsistencies that delay progress or compromise product integrity. This can be solved with a deliberately aligned infrastructure, using the same types of bioreactors and analytical platforms across our R&D and manufacturing facilities. Applying technical continuity smooths the transition from bench to large-scale production, reducing errors and improving reproducibility.
Involving manufacturing and quality control teams early in development is critical. These cross-functional teams work together to identify potential bottlenecks, like purification limitations or equipment compatibility, before they become issues. Collaboration between different teams ensures that the process is built with commercial readiness in mind from the start.
Another factor that can build continuity and confidence into scale-up is deep scientific engagement with each molecule. Rather than treating the process as a one-size-fits-all template, teams should work to understand the structure, behavior and potential risks of the molecule in development. This enables proactive mitigation strategies and helps preserve critical quality attributes as the process scales.
Speed and flexibility through digital and strategic integration
For emerging biotechs, speed is a competitive advantage and an integrated, agile approach helps deliver it without compromising quality. Advanced digital tools, proactive regulatory planning and adaptable infrastructure can help ensure scale-up that is both fast and strategic. Effective strategies include:
- Bioprocess modeling tailored to specific projects or platform processes
Bioprocess modeling plays a vital role in accelerating development and ensuring robust scale-up. When tailored to the unique characteristics of a molecule or process platform, bioprocess modeling supports both upstream and downstream design while reducing development cycles and enhancing predictability.
Technologies commonly used in this context include ambr® systems for optimizing lab-scale cell culture, multimodal chromatography on ÄKTA™ platforms for efficient protein purification and the Beacon Select System for high-throughput cell line development. These tools enable more informed decision-making and support seamless transitions from early development through to manufacturing.
● Early and continuous regulatory alignment to help prevent downstream bottlenecks
Involving regulatory affairs teams at the very start of each project ensures that every process is designed with compliance in mind. This early engagement enables tailored validation strategies appropriate to the project’s clinical phase, such as prioritizing only the essential qualification steps for Phase I trials. As a result, costly over-engineering is avoided and projects stay aligned with evolving regulatory expectations, reducing approval risks and keeping timelines intact.
● Right-sized manufacturing infrastructure to provide flexibility across development stages
Not all therapies require large-scale production. A diverse range of bioreactor capacities, from 50 L to 200 L, can be ideal for clinical batches, personalized therapies and targeted biologics. This scalable infrastructure enables biotechs to produce high-quality material at volumes appropriate to each development phase, avoiding unnecessary investment in oversized systems while maintaining agility as product demands evolve.
This combination of digital fluency, strategic foresight and infrastructure flexibility, enables biotechs to move quickly, pivot confidently and scale efficiently while maintaining regulatory and technical integrity.
Mabion: A true partnership for scaling efficiently
At Mabion, our team works as an extension of your team, rather than a service provider. Dedicated project managers serve as primary points of contact, while regular scientific meetings and transparent updates foster true collaboration. This relationship-first mindset helps build long-term partnerships that start small and scale strategically.
Scaling biologics from lab to market is a complex process but with the right biologics CDMO partner, it doesn’t have to be a risky one. We bring together scientific depth, operational flexibility and strategic collaboration to help biotechs confidently scale their innovations and bring them to patients faster.
