CDMO Services

From gene to GMP-grade protein, ORF Biologics is a U.S.-based contract development and manufacturing organization. We design, express, purify, and scale recombinant proteins, growth factors, and antibodies — all in-house, in Tiffin, Iowa.

End-to-end CDMO services under one roof

As your CDMO partner, we manage your molecule across its entire lifecycle — from initial construct design through scalable production and delivery — without handling your program off to third parties. Our proprietary “plug-and-play” expression platforms moves from gene to finished product quickly, so you reach usable material faster.

Cell line development — Construct design, clone selection, and stable pool generation optimized for yield and batch-to-batch consistency.

Upstream / expression — Protein expression across multiple host systems, from small-scale screening to production-scale culture.

Downstream / purification — Multi-mode chromatography and purification strategies tuned to your molecule’s profile.

Analytical & QC — In-process and final-product testing for identity, purity, potency, and stability — with a Certificate of Analysis on every lot.

Bulk & delivery — Bulk production and formulation, prepared and shipped to your specifications.

Tech transfer — Structured process documentation to support your downstream development and scale-up.

Industry Leaders We Manufacture For

We partner with teams at every stage — from first prototype to scaled supply.

Protein Research Innovators

Researchers working in fields like assay development, structural biology, or exploratory science rely on stand-alone, high-purity proteins to deliver accurate and reproducible results. Their work demands uncompromised bioactivity, batch-to-batch consistency, and technical data that supports rigorous validation, ensuring confidence in every experiment, from initial tests to peer-reviewed publication.

Biotech Pioneers

Biotech startups, diagnostics developers, and academic labs advancing product pipelines often require a dependable source of proteins or biologics. They value flexible, scalable production that can adapt to project evolution, formulation tweaks, or growing demand, paired with reliable supply logistics that won’t disrupt timelines or innovation milestones.

Drug Discovery Teams

Pharmaceutical companies and therapeutic developers seek advanced protein engineering and synthetic biology tools to create differentiated biologic candidates. They rely on early-stage manufacturing insight, functional prototyping, and iterative process design to fine-tune drug candidates, turning discovery into validated, scalable therapeutics for complex clinical challenges.

A biologics CDMO built on flexible expression systems

What makes ORF a versatile biologics CDMO is breadth of expression. We produce complex proteins many providers can’t — matching each molecule to the right host system instead of forcing it into a single platform.

If your target is hard to express, that’s exactly the kind of work we take on. Get in touch with our team for a custom solution.

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Host systems

CHO

HEK

Pichia

Bacillus

E. coli

Molecule types

Growth factors

Fusion proteins

Antibodies

Recombinant & complex proteins

Biologics CDMO Services: Frequently Asked Questions

What is a biologics CDMO?

A biologics CDMO (contract development and manufacturing organization) develops and manufactures biologic molecules on behalf of another company. ORF provides end-to-end biologics CDMO services — cell line development, expression, purification, QC, and scale-up — from a single U.S. facility.

What expression systems does ORF support?

We work across CHO, HEK, Pichia, Bacillus, and E. coli, matching each molecule to the host system best suited to it.

Can you scale from research to GMP-grade?

Yes. Our pilot-scale infrastructure bridges early discovery and industrial production, letting programs scale with process continuity rather than re-starting with a new partner.

Do you support cell therapy developers?

We supply cell lines, MSCs, custom media, and ancillary materials to cell therapy developers who need consistent, well-characterized inputs for their workflows.

Areas of Interest

Biologics offer transformative potential across a broad spectrum of diseases and conditions. Produced through advanced recombinant and expression technologies, they can be tailored for use in therapeutic areas such as immunology, oncology, neuroscience, wound healing and rare diseases. These versatile molecules are paving the way for new possibilities in research and therapeutics, providing scalable solutions for conditions that currently lack effective therapies.

Neuroscience

Oncology

Wound Healing

Autoimmune Diseases

We support the neuroscience field by providing advanced biologics that enable groundbreaking research and therapies for neurodegenerative diseases, brain injuries, and spinal cord regeneration. By offering high-quality, reproducible biologic formulations and data-driven characterization, we help researchers and clinicians unlock new approaches to treating conditions like Alzheimer’s, Parkinson’s, and stroke.

We partner with oncology researchers and biopharma companies to advance cancer treatments using our high-quality biologics, including antibody drug conjugates and recombinant protein therapeutics. Our expertise in immuno-oncology—featuring next-generation antibody drug conjugates and bispecific antibody therapies—enables more targeted, effective treatments with fewer side effects. We support the development of personalized cancer therapies that have the potential to transform patient outcomes.

We partner with researchers and clinicians to advance wound healing therapies using our high-quality biologics, including recombinant growth factors, extracellular matrix proteins, and engineered peptide scaffolds. Our expertise in regenerative medicine—featuring next-generation growth factor cocktails and bioactive scaffolds—enables more targeted, effective repair with reduced scarring and infection risk. We support the development of personalized wound healing solutions that have the potential to transform patient outcomes.

We partner with researchers to explore new therapies for autoimmune diseases by offering high-quality biologics that restore immune balance and promote tissue repair. Through immune-modulating proteins—such as monoclonal antibodies and receptor agonists—we enable advancements in treating conditions like rheumatoid arthritis, lupus, and multiple sclerosis, helping to reduce inflammation and prevent tissue damage caused by overactive immune responses.

OUR COMPANY

Committed to Scientific Excellence and Service

We work closely with our partners to commercialize best-in-class human growth factors, always ensuring that our products meet the highest quality standards. From the initial concept to final delivery, we are committed to maintaining open channels and providing exceptional support, ensuring your success in biopharma development.

OUR EXPERIENCE

Amplifying Discovery Outcomes

We offer high-value licensing and partnering opportunities with industry leaders and biopharma innovators to commercialize breakthrough biologics. Our expertise in protein engineering, advanced expression systems, and scalable production ensures the successful translation of discoveries into impactful solutions.