Recombinant Therapeutic Proteins

Recombinant therapeutic proteins encompass a broad range of biologic drug candidates. They are predominantly produced using mammalian expression systems to ensure targeted therapeutic activity, replace missing or deficient proteins in the body, modulate immune responses, or serve as vaccine antigens.

Mabion supports clients in the development of recombinant therapeutic proteins by combining expertise in biologics development, scalable manufacturing, analytical characterization, and flexible collaboration models. We help innovators progress from the conceptual stage to clinical and commercial development with greater regulatory and market awareness.

Recombinant Therapeutic Proteins modalities supported

Potential recombinant therapeutic protein formats include:

• Recombinant enzymes – used as enzyme replacement therapies or therapeutic biocatalysts, where robust expression and purification are critical to activity and consistency.
• Fusion proteins – which combine functional protein domains to improve targeting, half-life, potency or manufacturability.
• Fc-fusion proteins – designed to extend serum half-life and simplify purification through Fc-based properties.
• Antibody fragments (such as Fab, scFv, dAb or single-domain antibodies) – which can offer smaller size, tissue penetration or novel binding properties.
• Peptibodies – which combine peptide or protein domains to enhance pharmacological performance.
• Cytokines and Interleukins – which modulate immune signaling and require precise control of potency, purity and biological activity.
• Growth factors – which stimulate cell growth, differentiation or tissue repair and require careful characterization of bioactivity and variants.
• Recombinant hormones – which replace or regulate physiological functions and demand high batch-to-batch consistency.
• Coagulation factors and other plasma protein analogues – which support replacement therapy and require stringent control of structure and functional activity.
• Receptor proteins and ligand traps – which bind soluble targets and can neutralize disease-driving pathways.
• Glycoproteins – where control of glycosylation, charge variants and higher-order structure is central to product quality.
• Recombinant vaccine antigens – which present defined antigenic structures and require scalable, reproducible production.

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Recombinant Protein Manufacturing Services

Mabion helps biotech and pharmaceutical companies reduce execution risk by offering drug substance manufacturing services for recombinant therapeutic proteins across development stages. By integrating upstream processing, downstream purification, process validation, Mabion gives clients a single experienced partner for transforming a recombinant protein candidate into a controlled, scalable and regulatory-ready drug substance.

Whether the project requires clinical trial material, scale-up, validation or preparation for commercial supply, Mabion’s manufacturing model is built to support quality, flexibility and compliance while helping clients protect timelines and maintain product consistency.

Analytical Services for Characterizing Recombinant Therapeutic Proteins

Successful development of recombinant therapeutic proteins depends on deep analytical understanding of it. Mabion supports customers with analytical services that help characterize critical quality attributes, confirm process performance, compare product variants and generate data packages that support development, quality control and regulatory decision-making.

As part of our analytical offering, we provide comprehensive characterization of critical product attributes, including identity, purity, potency, heterogeneity, stability, and biological activity. We also offer the development, qualification, and validation of dedicated analytical methods tailored to specific project requirements. All analytical services at Mabion are performed in strict compliance with International Council for Harmonisation (ICH) guidelines, as well as European Pharmacopoeia (Ph. Eur.) and United States Pharmacopeia (USP) standards, with a strong emphasis on a Quality by Design (QbD) approach.

For the client, robust analytics translate into better decisions earlier in development.

Process Development for Recombinant Therapeutic Proteins

Mabion’s process development services support the design and scale-up of manufacturing processes for recombinant therapeutic proteins. We can assist clients regardless of whether the starting point is an early-stage research concept, an existing laboratory-scale process, or a process requiring optimization before GMP manufacturing. Our work may include cell line development support, upstream process development, downstream purification strategy design, scale-up activities, process optimization, process characterization, and preparation for process validation.

The primary benefit for clients is a more efficient manufacturing process, resulting in lower costs at the most resource-intensive stages of development and production. By focusing on process control and robustness, Mabion’s experts help create a smoother transition from development to GMP-compliant manufacturing, enabling sponsors to accelerate program timelines without compromising quality expectations.

Mabion Co-development Model

For selected recombinant therapeutic protein projects, Mabion can act not only as a service provider but also as a strategic co-development partner. In this model, partners benefit from Mabion’s integrated biologics capabilities, while sharing selected responsibilities, risks and value-creation opportunities in a deeper collaboration.

This approach is especially valuable for companies that need more than capacity. By collaborating with Mabion in a co-development model, sponsors can gain access to specialized recombinant therapeutic protein expertise while building a partnership designed around long-term product success.