A Team of Experts

View PDF

 

Who We Are

 

 

Based in Grenoble, France, PX’Therapeutics (formerly known as Protein’eXpert) is a contract research and manufacturing organization devoted to the development of biotherapeutics. Our 50-person staff offers custom-designed services ranging from recombinant protein and monoclonal antibody discovery and optimization up to clinical cGMP manufacturing for preclinical and clinical studies.

 

Acknowledged Scientific Expertise

 

We have demonstrated our high level of expertise in protein science and our capability to tackle complex and recalcitrant projects. We have indeed worked on more than 500 projects for 140 clients worldwide and released clinical batches for trials performed in Europe and in the United States.

 

Integrated Organization for Seamless Transfer

 

We differentiate from other CMOs by our integrated way of working from discovery stage to phases 1–2 clinical production. This original and science-driven approach ensures seamless transfers during the project’s life and therefore leads to significant reduction in R&D budget and development timelines. We also commit ourselves to ensure an optimal transfer to partner CMOs offering large-scale facilities for phase 3 and market production.

 

A Collaborative Way of Working

 

At PX’Therapeutics, we like to work collaboratively with our clients and partners. Past experience has demonstrated that our friendly style of interaction and research-based approach have allowed us to set up trusted and productive relationships.

 

Project Management

 

We assign a dedicated project director to all research or manufacturing programs. He is responsible for coordinating the development team associated to a project as well as ensuring that timelines are observed and objectives reached. He will also maintain a transparent and efficient communication with our customers through regular updates on their programs’ progress and by quickly addressing their questions or needs.

 

Quality Assurance and Regulatory Affairs

 

The whole organization works toward quality standards to ensure that its business and production processes generate maximum performances and meet customer satisfaction. PX’Therapeutics complies with ISO 9000:2000 international quality standards and all therapeutic projects are performed according to the international regulatory GMP guidelines (ICH, EMEA, and US FDA).

 

Recombinant Protein Platform

 

Expression Systems: bacterial, yeast, insect cells, and mammalian cells

  • Molecular biology
  • Protein engineering
  • Feasibility study
  • Refolding development
  • Monoclonal cell line development
  • Process development (USP, DSP)
  • Research contract

 

 

cGMP Biomanufacturing

 

  • Analytical methods development
  • Cell banking
  • Preclinical manufacturing
  • cGMP clinical manufacturing
  • Clinical batch release
  • Stability study
  • Regulatory support

 

Monoclonal Antibody Platform

 

  • Production of difficult to express immunogens
  • Flexible mouse immunization strategies (from protein, DNA, transfected cells, etc.)
  • Subtractive immunization approach for development of antibodies directed against weakly antigenic or rare epitopes
  • Generation of hybridomas and cloning
  • Production and purification of antibodies
  • Chimerization and humanization strategies