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

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Analytical capabilities

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

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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