BELLEROPHON Call for process development and GMP manufacture of a vaccine candidate

17 June 2015

BELLEROPHON would like to make a call for the process development and production in E. coli according to Good Manufacturing Practice (GMP) of a protein vaccine candidate to be used in toxicological and phase I studies.  The subcontracting is expected in Q4 2015.

S. aureus, including methicillin resistant S. aureus (MRSA), is one of the most important bacterial pathogens, causing skin lesions, and deep infections in both the community and in hospitals.  Treatment is difficult and expensive and may require prolonged intravenous antibiotic therapy.  Since there is no vaccine licensed by the US Food and Drug Administration (FDA) or European Medicines Agency (EMA), interception also relies heavily on antimicrobials to which antibiotic resistance is developing.  To reduce S. aureus disease burden, and antibiotic use associated with it, BELLEROPHON an EC FP7 funded project intends to design, manufacture, and assess in a phase I clinical trial a novel S. aureus vaccine candidate targeting both the cellular and humoral responses.  It is designed to protect against both MRSA and more sensitive S. aureus strains.  The pan-European BELLEROPHON project comprises four European institutions involved in vaccine development, each contributing specialist expertise and technology: Imaxio, a French biotech company focused on immunology, the Jenner Institute at University of Oxford (UOXF), UK, an academic institution with key expertise in S. aureus antigens and viral vector delivery systems, who is coordinating the overall project.  Another partner, EVI is assisting with project management tasks and advising on production and the clinical aspects of the project.  The fourth member is Preclin Biosystems, a Swiss contract research organisation with strong expertise in preclinical efficacy models for infectious diseases.

BELLEROPHON would like to make a call for the process development and production in E. coli according to Good Manufacturing Practice (GMP) of a protein vaccine candidate to be used in toxicological and phase I studies.  The subcontracting is expected in Q4 2015.

 Responsibilities:

  • To manufacture a pre-Master Cell Bank (Research Cell Bank) of ~ 50 vials with full raw materials traceability
  • To manufacture 100 vials (minimum) of a GMP Master Cell Bank with full quality control (QC) and release. To carry out the cell bank storage
  • To develop an upstream process in fermenters and adapt a purification process at small scale. A lab scale process (in Erlenmeyer flasks) already developed by IMAXIO will be transferred to the CMO
  • To scale up the process at the GMP manufacturing scale
  • To transfer / adapt analytical methods provided by IMAXIO
  • GMP manufacturing of the bulk drug substance(DS) (1 to 3g or at least 10 litres of fermenter), with QC, QA and release
  • GMP manufacturing of the drug product (DP), fill & finish, with QC, QA and release
  • DS and DP ICH stability studies

Eligibility Criteria

  • Audited facility with GMP certificate; registered at “Crédit Impôt Recherche» (French research tax credit)
  • Willing and able to develop and manufacture the cell bank, and the protein according to GMP.
  • A fully equipped Research & Development (R&D) and GMP production standard facilities
  • A willing and motivated team
  • Previous experience with development and manufacture of recombinant proteins and vaccines according to GMP

Application:

The applicants should submit a maximum ten page summary (Garamond, font size 11), including description of the subcontractor, the R&D and GMP production capabilities, previous experience with protein development and production, timelines, budget breakdown, etc. 

Timelines

  • All applications must be submitted by close of day (17:00 CET, 16:00 GMT) on 15 August 2015.  Any applications submitted after this time will not be considered. 
  • Communication on the successful applicant will be made within three months of the deadline for receipt of applications.

All requests for information and submission of applications should be made in English to:

BELLEROPHON (bellerophoninfo [at] euvaccine [dot] eu)

 BELLEROPHON Partners

University of Oxford, UK

University of Oxford is one of the most highly ranked universities in all global assessments.  Infection and Immunity is an area of particular strength in the division of medical sciences, with a particular focus on tropical infections and vaccines.  The focus of vaccine research and development activities is the Jenner Institute with clinical activities at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) and biomanufacturing at the adjacent GMP Clinical Biomanufacturing Facility (CBF).  The Jenner Institute embraces 26 principal investigators and about 300 researchers all aiming to develop better vaccines of a variety of human and veterinary infectious diseases.  The Jenner Institute is one of the largest non-profit vaccine institutes globally with vaccine candidates in clinical development in Africa for malaria, HIV/AIDS and tuberculosis.

IMAXIO

IMAXIO is an integrated biotech company focused on vaccines, and based on the combination of commercial and R&D activities.  25 employees are engaged in the R&D pipeline based on the IMX313 technology platform aiming antigen re-engineering platform to improve vaccine immunogenicity, to develop more effective vaccines & immunotherapies.  IMAXIO is producing a vaccine against human leptospirosis and an orphan drug indicated in Wilson disease, both of them marketed in France.  IMAXIO’s main objective is to develop its R&D projects up to phase I / phase II clinical trials, to be out-licensed to biopharmaceutical companies able to push forward the related vaccines & immunotherapies development up to phase III and commercialization. 

PRECLIN, Switzerland

Preclin Biosystems AG is a small and dynamic Swiss-based biotechnology company that offers an extensive range of infectious and chronic inflammatory disease models for testing the efficacy of lead candidate therapeutics and vaccines.  The scientific team behind Preclin Biosystems has well over 40 years of experience modelling infectious and inflammatory diseases in mice and identifying the cellular and molecular mechanisms that drive the disease.  The company has access to first-class infrastructure such as biosafety 2 laboratories and advanced Specific Pathogen Free (SPF) biosafety 2 animal facilities. Furthermore, Preclin Biosystems AG possesses all of the required permissions to perform animal experiments with biosafety 2 pathogens.

European Vaccine Initiative, Germany

The European Vaccine Initiative (EVI) is a non profit European Economic Interest Grouping (EEIG) that aims to provide a mechanism through which the development of vaccines for diseases of poverty (DoP) can be accelerated within Europe and in low income countries.  EVI’s scope of operation is in facilitating the transition from academic research to vaccine candidate by providing expertise and direct funding for the production of cGMP clinical batches and early clinical development.  This gap in vaccine development is both technically and legally complex and has traditionally been under financed.  As a result, EVI funding is targeted at diseases where the profit motive does not drive the development.  The EVI strategy includes: Vaccine portfolio management in close collaboration with Malaria Vaccine Funders Group, technology platforms: adjuvant, formulation, immune-assays, Innovation: antigen delivery, route of administration, optimising GMP production (yield, heat stability etc), dialogue with policy makers: EVI organises consultations through workshops or working groups on specific scientific, regulatory, societal, or ethical questions, and advocacy on control/eradication of DoP to sustain and mobilise the funds for translational research.

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