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The Italian SME is a CDMO (contract development manufacturing organisation) specialized in developing biomedical products for advanced therapies and genetic vaccines. The company offers customized solutions based on client's requirements from early development to manufacture and clinical release.
The company is seeking research and technical cooperation agreements with Pharma or Biotech companies dedicated to gene therapy or genetic vaccines that need to develop or produce viral vectors
The SME company's management and scientific teams have successfully developed genetic vaccines against several infectious diseases through a highly innovative adenovirus-based platform. These vaccines have been evaluated in thousands of healthy subjects of all ages, as well as in patients with chronic viral infections and shown to be safe and highly immunogenic. The company has R&D laboratories specialized in the isolation and genetic manipulation of wild-type viruses through vectorization and transgene engineering.
Additionally, the company has state-of-the-art technologies and expertise to evaluate the immunological responses to viral vectors in samples from preclinical models and clinical studies.
Over the last years the company has developed a unique expertise in the process development and in the large-scale GMP production of viral vectors such as MVA (Modified Vaccine AnKara), AAV (adeno-associated virus) and adenovirus. The good manufacturing practices (GMP) manufacturing facility meets the most stringent criteria to produce material to be used in human clinical studies.
The company has a well proven ability to develop for main-pharmaceutical actors clinical batches of viral vector-based medicinal products. The SME is seeking for research and technical cooperation agreements with primary pharma or biotech companies that need dedicated and specialized collaboration for gene therapy or genetic vaccines that need to develop or to be produced by mean of viral vectors.
The italian SME proposes innovative approaches to the development of novel viral platforms through isolation of novel virus strains from human and non-human species and vector engineering.
Additionally, the SME offers a state-of-the-art, fully-equipped multiproduct GMP facility service equipped with quality control laboratories, inclusive of filling suite with a fully automated aseptic filling machine.
The advantages offered by the processes are:
- Unique expertise in large-scale GMP viral cell culture, up to a 200L scale and concomitant GMP activities.
- Large capabilities to accommodate different upstream platform by using wave technologies as well as a stirrer tank bioreactor (STR- bioreactyor) for suspensions cells or different incubators for adherent cells amplification.
- Robust expertise in downstream process by applying large scale clarification by using depth filters. Molecules separation by applying chromatographic techniques on different instruments like Akta-pilot, Akta-process or fully disposable Akta-ready equipped with both resins or membranes.
-Solid experience in ultrafiltration techniques by applying tangential flow filtration on different instruments like spectrum KPM (kernel polynomial method), Cogent Millipore equipped with both hollow fibers or cassettes.
-Unique expertise in validation of the aseptic process for clinical bulk Drug Substance (DS) and clinical Drug Product (DP) manufacturing.
- Large viral vector manufacturing portfolio
The company has preclinical and clinical production capacity of these technologies
Technology secrecy is assured by confidentiality agreements with collaborating companies
The SME is seeking for research and technical cooperation agreements with primary pharma or biotech companies. the SME offers processes and capability already tested and proved that need dedicated for gene therapy or genetic vaccines. Especially for those that need to develop or to be produced by mean of viral vectors.