Process Development

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Our experts in Upstream and Downstream Development provide personalized attention and ensure the most effective and innovative solutions for your complex challenges

Our flexible facility 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.

proteins

1%

higher productivity

Our team combines in-depth protein scientific knowledge with a lot of process development expertise having increased productivity in 98% of our projects

Custom 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 succesfully 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 30 liters 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.

Custom 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.

Our tailored approach, combined with our state-of-art equipment are used for developing an efficient, robust, and scalable process development to make the leap from pilot scale to manufacturing

We have the ability to solve complex problems that arise during process development and for this reason, we dare to take on protein projects that not fit into the standards

Discover more about 53Biologics protein services

Strain & Cell Line Development

We have wide experience in E. coli, P. pastoris and fungal strain development and mammalian cell line development for the manufacturing of your biologic.
cell banking

Cell Banking

We are fully capable to produce and characterize Master Cell Banks (MCB) and Working Cell Banks (WCB) in our GMP compliant suits.

Protein Manufacturing

We offer a wide range of manufacturing capacities for your enzymes, monoclonal antibodies, biosimilars or vaccines under GMP and non-GMP conditions.

Analytical Services

From early development to commercial manufacturing, we provide multiple analytical testing services to support your protein project.

Do you want to develop a robust production process for your protein?