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  • GMP Manufacturing

    Right-scale GMP manufacturing with global quality standards

    From clinical to commercial, we ensure seamless scale, on-time delivery, and uncompromising quality

    Trusted quality

    Facilities with proven regulatory compliance, inspected by the FDA, EMA and other global regulators

    Seamless scale

    Single-use, mirrored facilities that support programs from clinical to commercial

    Reliable delivery

    On-time, in-full manufacturing backed by ownership, accountability, and collaboration

    “We partner with our clients to ensure their molecules are manufactured with the same care as if they were our own.”

    Anna Zamojska Drug Substance Manufacturing Director, Rezon Bio
    Without Rezon Bio

    When limits block progress

    • Scaling limitations
    • Lack of MSAT expertise
    • Weak process qualification
    • Limited regulatory support
    • Costly, high-risk tech transfers
    With Rezon Bio

    Capacity that grows with you

    • Seamless scale
    • Eliminate revalidation
    • Flexible entry points
    • Launch-ready
    • Safer launches
    Discover our Capabilities

    Lean GMP. Lower costs.
    No compromise.

    Cut COGS without trade-offs. Lean, single-use GMP workflows, smart slotting, and digital twin optimization drive faster cycles, higher yields, and reliable QA/QC.

    Efficient workflows

    Lean GMP processes optimized to minimize waste and variability, ensuring consistent reliability while keeping costs under control

    Smart slotting

    Intelligent scheduling reduces idle time and accelerates campaign starts, enabling faster throughput and better use of manufacturing capacity

    Digital optimization

    Model-based, digital twin simulations drive line efficiency, improve yields, and allow proactive adjustments before issues occur

    Single-use systems

    Flexible single-use infrastructure lowers cleaning requirements, reduces downtime, and minimizes cross-contamination risks

    Predictable pricing

    Transparent pricing models – campaign-based, gram-based or shared capacity – deliver cost clarity and support confident project planning

    Discover our Facilities

    Advanced GMP services 
and technology

    Rezon Bio provides end-to-end GMP manufacturing in mirrored, single-use facilities – enabling rapid scale-up, flexible capacity, and consistent quality

    Commercial GMP Manufacturing

    Large-scale GMP facility offering full technical development and commercial-scale manufacturing

    50L SUB
    500L SUB
    2000L SUB

    Clinical GMP Manufacturing

    Full technical development and medium-scale manufacturing center

    50L SUB
    250L SUB
    1000L SUB
    Partnership process

    Future-proof capacity,
    built around your goals

    Growing pipelines need flexible capacity, not rigid contracts that slow progress. We deliver partnerships designed to move with your needs.

    Partnership process

    We design a partnership model that matches your goals

    1. Listen and understand

    We start by understanding your product and needs

    2. Design your model

    We shape a pricing and collaboration model that fits

    3. Tailor terms

    We align contracts with growth and
    lifecycle changes

    4. Scale together

    We expand capacity in line with client needs

    Partnership process

    Where dedication delivers capabilities

    End-to-end drug substance and drug product solutions deliver “ready to fill” products faster, at lower cost, with greater efficiency

    Process development & characterization

    Scalable upstream and downstream processes built for robustness

    Read more

    Analytical capabilities

    Phase-appropriate, method-qualified testing for product quality and release

    Read more

    Quality

    Systems aligned with regulatory requirements, confirmed by successful inspections and focused on lifecycle aspects

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    Explore Benefits

    Partner with us

    We combines the scale of an established CDMO with the agility of a focused partner, backed by proven end-to-end biologics expertise.

    Integrated solutions

    From development to manufacturing, reducing delays and risks

    European facilities

    GMP sites built for seamless scale-up and reliability

    Uncompromised quality

    Manufacturing sites approved by FDA and EMA, ensuring global compliance

    Efficiency without compromise

    Lean operations deliver cost efficiency with quality

    Expert teams

    Skilled teams ensure consistent execution and stability

    Ready to get started?

    Where innovation
    meets execution

    1. Whether you’re advancing a novel biologic or planning for commercial scale, Rezon Bio is ready to help you move forward with confidence
    2. Connect with our team to explore how our expertise, integrated solutions, and dedication can accelerate your success