Protein Projects Integrated Development

BPI Contributor

July 1, 2008

3 Min Read

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Founded in 2000 in Grenoble, France, Protein’eXpert is an expanding contract research organization devoted to recombinant protein engineering and production. Our 50-member staff offers custom-designed services focusing on the discovery, optimization, and production of valuable target or therapeutic proteins.

Since 2004, Protein’eXpert has extended its offering to the biomanufacturing of therapeutic protein and recombinant vaccines for early clinical trials through its integrated subsidiary PX’Pharma. PX’Pharma provides dedicated contract services for process development and scale-up optimization as well as preclinical and clinical CGMP manufacturing.

Integrated Organization for Seamless Transfer

We differentiate from other protein CMOs by our integrated way of working from early stage research to phase 1 and phase 2 clinical production. This original approach ensures seamless transfers and therefore leads to significant reduction in protein development–related budget and time. Our programs are set up to ensure optimal transfer to partner CMOs offering largescale facilities for phase 3 and market production.

Acknowledged Expertise in Protein R&D

We have demonstrated our capability in tackling highly complex and recalcitrant protein projects and in taking them to production stages. We have worked on more than 500 proteinrelated projects for 120 European and American clients.

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A Collaborative Way of Working

At Protein’eXpert, we are used to working collaboratively with our clients and partners. Past experience has demonstrated that our friendly style of interaction and research-driven approach allow us to set up trusted and productive relationships.

Project Management

We assign a dedicated project manager to all research and manufacturing programs. This person is responsible for coordinating the development team associated to a project as well as ensuring that timelines are observed and objectives are reached. The project manager also maintains transparent and efficient communication with our customers through regular updates on their program progress and by quickly addressing their questions and needs.

Quality Assurance and Regulatory Support

The whole organization works toward quality standards to ensure that its business and production processes generate maximum performance and meet customer satisfaction. Protein’eXpert complies with ISO 9000:2000 international quality standards. All work at PX’Pharma is performed according to international regulatory GMP guidelines (ICH, EMEA, and FDA).

Range of Services

  • Molecular biology

  • Protein engineering

  • Feasibility studies

  • Refolding development for insoluble proteins

  • Process development (USP, DSP)

  • Analytical methods development and validation

  • Cell banking

  • Preclinical manufacturing

  • CGMP clinical manufacturing

  • Clinical batch release

  • Stability studies

Expression Systems

  • Bacterial

  • Yeast

  • Baculovirus (insect cells)

  • Mammalian cells

Projects Addressed

  • Therapeutic proteins for clinical trials

  • Recombinant antigens for vaccine development

  • Target proteins for rational drug design

  • Protein for structural studies (crystallogenesis/NMR)

  • Protein for functional studies and enzymatic assays

  • Protein variant generation and screening

  • Proteins for microarrays

New: Creation of Px’Monoclonals

Our new Px’Monoclonals subsidiary offers custom research and production services addressing the development of murine and humanized therapeutic antibodies:

  • Production of difficult to express immunogens

  • Flexible immunization strategies (from protein, DNA, transfected cells, etc.)

  • Subtractive immunization for development of antibodies directed against weakly antigenic or rare epitopes

  • Generation of hybridomas and cloning

  • Scale-up production and purification of antibodies

  • Development of chimeric or humanized antibody using molecular modeling and engineering strategies.

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