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Desarrollo y producción de vectores virales para vacunas genéticas y terapias avanzadas

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOIT20190916001
Publicado:
27/09/2019
Caducidad:
27/09/2020
Resumen:
Una organización de desarrollo y fabricación por contrato (CDMO) italiana especializada en desarrollar productos biomédicos para terapias avanzadas y vacunas genéticas ofrece soluciones a medida basadas en los requisitos del cliente, desde el desarrollo temprano hasta la fabricación y divulgación clínica. Sus equipos de gestión y científicos han desarrollado con éxito vacunas genéticas contra diversas enfermedades infecciosas mediante una nueva plataforma basada en adenovirus. Estas vacunas han sido analizadas en miles de individuos sanos de todas las edades y en pacientes con infecciones víricas crónicas, y han demostrado ser seguras y altamente inmunogénicas. También dispone de tecnologías vanguardistas y experiencia para evaluar las respuestas inmunológicas a vectores virales en muestras, desde modelos preclínicos hasta estudios clínicos. La empresa busca compañías farmacéuticas y biotecnológicas especializadas en terapia génica o vacunas genéticas que necesiten desarrollar o producir vectores virales. La cooperación se establecerá en el marco de un acuerdo de investigación y cooperación técnica.

Details

Tittle:
Development and manufacture of viral vectors for genetic vaccines and advanced therapies
Summary:
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
Description:
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-Y-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.
Advantages and Innovations:
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
Stage of Development:
Field tested/evaluated
IPs:
Secret Know-how
CommeR Statunts Regarding IPR Status:
Technology secrecy is assured by confidentiality agreements with collaborating companies

Partner sought

Type and Role of Partner Sought:
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.

Client

Type and Size of Client:
Industry SME 50-249
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English
Italian

Keywords

Technology Keywords:
06002002 Biología celular y molecular
06002009 Diseño molecular
06002007 Ensayos in vitro, experimentos
06002005 Ingeniería genética