Process Development for Protein Production

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Our experts in Upstream and Downstream can develop a robust and reproducible process

Our flexible operation structure is specifically designed to adapt the process development to the characteristics of your protein and expression system, accelerating the timelines from pre-clinical concept to manufacturing and reducing risks and costs.

Upstream Development

Whether your project requires full upstream process development from scratch or only its optimisation, we will design a customized development approach. We have successfully develop processes for antibodies, biosimilars, growth factors, molecular biology reagents, virus like particles and vaccines.

Our wide experience working with different microbial and mammalian expression systems ensure the best expertise to increase productivity and growth performance for your recombinant protein. Different fermentation scales from 1 to 30L with the ability to work in parallel, with different configurations (i.e. Stirred, wave-induced motion, etc.) and different industrial solutions like glass, stainless steel, single-use bioreactors, etc. are available. Consult our facilities.

process development


Over 98% of the proteins in our hands had improved recovery performances

process development

Downstream Development

We develop customized downstream processes according to the characteristic of your protein and its intended use. Our team has extensive experience developing purification schemes enabling them to overcome purification problems for a wide variety of proteins, soluble or insoluble, whether they are produced in the periplasm, cytoplasm or into inclusion bodies.

At 53Biologics, we offer a diverse range of state-of-the-art equipment, including both disc and stack centrifuges, depth filtration systems, UF and MF units, as well as advanced techniques like tangential flow filtration (TFF). Additionally, we count with high-pressure homogenization (HPH) systems for intracellular expression and platforms such as AKTA for affinity, size exclusion and ion exchange chromatographies. This ensures the development of efficient, robust and scalable production processes to leap from pilot scale to manufacturing

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