Our expertises

Expert know-how in the fields of bioproduction, anti-infectives and bacteriophages

BioMaje helps innovative biotechnology laboratories to perfect, develop and/or optimize their bioproduction tools. Through field experiences in operational, technical, pharmaceutical, and agile project coordination, BioMaje supports you in developing innovative anti-infectious approaches, particularly in the field of pharmabiotics (microbiota and bacteriophages).

Bioproduction

In the perspective of having variable-geometry tools with affordable manufacturing costs, bioproduction is undergoing radical change. Health systems can no longer afford overpriced treatments. Just as bioproduction has shifted from stainless steel reactors to disposable plastic systems and, in the future, to recyclable systems, the production of biological drugs must tend towards reducing manufacturing costs.

BioMaje helps you design and deploy agile and frugal methods and processes to manufacture small batch for a personalized medicine approach, up to millions of treatments commercial batch. The processes must be thought out as early as possible to reach an acceptable production cost; they must be designed to facilitate the transition to industrial production according to Good Manufacturing Practices (GMP), Pharmacopoeias and / or monographs. Quality control tests must be developed early to ensure quality, reproducibility, and campaigns traceability.

Antimicrobial

BioMaje experts were among the first to develop the screening, characterization, and production of bacteriophage viruses, intended to treat bacterial infections, including those resistant to antibiotics (AMR). This new therapeutic approach has been submitted to regulatory agencies in several countries, while developing original preclinical, clinical and bioproduction evaluation methods. The aim is to register it in the European Pharmacopoeia. These treatments now make it possible to treat patients who have failed antibiotic treatments.

The study and evaluation of anti-infectious diagnostics (antibiograms, phagograms, biofilm, Sars-Cov-2 serological detection test, etc.) are also part of BioMaje skills.

Our experts

BioMaje relies on a network of senior experts in activity, all trained by their significant experience in biotechnology and pharmaceutical industry, as well as agile project leadership.

Jérôme Gabard
Jérôme Gabard
(PhD in Molecular and Cellular Biology)

More than 30 years of experience in startups, innovative SME’s and large groups in R&D, bioproduction and regulatory affairs. A purple squirrel capable of having a global vision of biopharmaceutical, pharmabiotics, probiotics, development.

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Bioproduction
Strategy for developing and manufacturing new antibacterial. Development from scratch of a unit to produce bacteria and bacteriophages. Evaluation of the production capacities of CMO subcontractors. Constitution and defense of regulatory files (IMPD) with drug agencies (ANSM, EMA, Swissmedic, FAMHP).
Antimicrobial
design participation, submission (to ethic committees from different European countries) and management of international preclinical and clinical studies to test the safety and efficacy of antimicrobial treatments against bacteria including antibiotic-resistant strains. Open innovation mode including SMEs, hospitals and / or university labs. Participation in the government Committee (CSF) to define the plan for the preservation and development of innovations in the bacterial arsenal. Evaluation of different diagnostic tools (phagogram, biofilm, antibiotics, SARS-Cov-2…).
Isabelle Arnaud
Isabelle Arnaud
(PhD in industrial pharmacy)

30 years of pharmaceutical industry in Startups, and SMEs, including 8 years as Qualified Person (to guarantee that pharmaceutical product batches released on the market comply with the regulations). Expert in pharmaceutical regulations, Pharmaceutical Good Manufacturing Practices (GMP) and in quality.

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Building or consolidation of the regulatory status to become industrial pharmaceutical laboratory. Implementation of GMP and/or certification for the manufacture of drugs (bacteriophages, cell therapy; sterile products, small and medium scale). Production of cell and virus banks and quality control activities. Clean rooms: classes A, B and C, L2 and L3. Quality control department, internal quality auditor. Former member of the "Bioproduction Quality Group" of LEEM "Les Entreprises du Médicament".

David Bouyat
David Bouyat
(INSA engineer)

25 years of experience. Innovative and pragmatic troublemaker. Help customers in the agile and digital transformation of their organization.

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Transition management at the technology and data level as CTO (Chief Technology Officer) and agile coach. Within large accounts and mid-cap companies, technology transformation is escorted by opening to innovation through startups and innovation labs (Schoolab, etc.) with a transition to industrial mode via digital accelerators, frugal innovation and Design Sprint organization.

Examples of experience in the life sciences industry: evaluation and promotion of serological diagnostic tests for Sars-Cov-2 virus; industrialization of the information system dedicated to managing Air Liquide's 300,000 sleep apnea devices. Design of new industrial solutions at Saur to better manage the water cycle of industrial customers. Co-founder of a bioinformatics company (Sibio).

Dr Patrick Jault
Patrick JAULT
Dr Patrick JAULT (Md)

He is an intensive care anesthesiologist. He acquired his medicinal experience notably in the theaters of external operations within the French military health service

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He now works in a private clinic in Paris (France). Prior to that he coordinated PhagoBurn, the first multi-centric European clinical trial on phage therapy. He brings his clinical expertise to the development of the tools of tomorrow’s medicine, including for fighting infections.