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Advaxia Biologics

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Advaxia Biologics

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Lab Biography

Advaxia Biologics (formerly Advent), part of the IRBM group, is a cGMP Contract Development & Manufacturing Organisation (CDMO), located near Rome (Pomezia) Italy, compliant with the regulatory guidelines of the EMA, MHRA and FDA. Advaxia?s integrated contract services portfolio includes outstanding support in the areas of analytical method development, process development/validation, in-process assay development & qualification, GMP Manufacture, full QC product release, ICH Stability and cell banking. Advaxia is dedicated to the development and production of clinical lots of recombinant adenoviruses to support clinical trials for vaccine and gene therapy applications. The Advaxia team has built an outstanding track record in the production of clinical lots for many infectious diseases, including Ebola, HIV and supported the global effort to expedite delivery of a COVID-19 vaccine.

Qualifications

?Certificate Nø IT320710, ISO 14001-2015, 28 Dec 2022, Environment ?Certificate Nø IT320712, ISO 45001:2018, 28 Dec 2022, Safety ?Certificate Nø 62466, UNI/PdR 125:2022, 29 Dec 2023, Measures to ensure gender equality in the workplace ?Certificate Nø ISP091, UNI ISO 30415:2021, 04 Jan 2024, Gestione delle risorse umane ? Diversit e inclusione ?Certificate Nø 62419, ISO-50001:2018, 15 Dec 2023, Sistema di Gestione dell’Energia ?Certificate Nø IT327278, ISO/IEC 27001:2022, 28 Nov 2023, Information Security Management System ?BSL-2 labs accredited by Ministry of Health since 2011 ?GMP facility, accredited by AIFA since 2012 (inspected by AIFA 2011, 2014, 2017, 2019 2020): ?Pilot plant for the production of biological investigational medicinal products (prophylactic and therapeutic vaccines). Approved for the production of investigational adenovirus vaccines for infectious diseases and gene therapy applications. Authorized also for API production. ?Authorized for testing of human medicinal products (commercial AZD1222 vaccine). Certification obtained in 2021. ?Last MIA in 2023, AIFA Nø aM 130/2023, 28/09/2023. Last GMP certificate in 2023, IT/156/H/2023

Industry Types Served

  • Environmental & Waste Management
  • Oil & Gas Products

Lab Testing Types Offered

  • Analytical & Quality Control Studies
  • Biologics & Cell-Based Assays
  • Biology & Life Sciences
  • Biotechnology & Gene Editing
  • Consumer Goods Testing
  • Fluid & Fuel System Evaluations
  • Formulation & Drug Release Studies
  • Gastrointestinal & Renal Testing
  • Genetics & Genomic Testing
  • Infectious Disease & Serology Testing
  • Juvenile Products & Toy Testing
  • Medical & Clinical Testing
  • Medical & Healthcare Product Safety Testing
  • Performance & Regulatory Marks Certification
  • Performance Testing
  • Pharmacology & Drug Development
  • Pharmacology & Therapeutic Drug Monitoring (TDM)
  • Physical Testing
  • Plant & Environmental Biology
  • Protective Systems & Life Safety Testing
  • Safety Certification & Testing
  • Thermal Stability & Oxidation Resistance Testing

Location

Via Pontina km 30.600, Pomezia, Rome, IT, 00071

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