The Manufacturing Facility
Advent is a CMO with GMP certifications issued by the competent regulatory authorities, designed for the production of biological investigational medicinal products (prophylactic and therapeutic vaccines). Advent has been approved for the production of adenovirus-based vaccines for infectious diseases and gene therapy.
The Advent cGMP manufacturing facility covers a surface of approx. 750 m2 and it is comprised of five C-grade (ISO 8) classified independent production rooms, one C-grade (ISO 8) classified purification rooms and one B-grade (ISO 7) classified clean room dedicated to fill & finish.
The facility in detail:
- 2 Clean cells rooms
- 2 Virus production rooms
- 1 Virus purification by AEX room
- 1 Media preparation room
- 1 Fill and finish room
- 1 Buffer storage room
The plant also includes an integrated controlled temperature unit storage system, monitored around the clock, that includes an ultra-low freezer system, vapor phase LN2 tanks and related emergency backup devices.
Furthermore, the facility includes a manufacturing-dedicated warehouse area and a BMS (Building Management System) check point.
The range of cGMP production services and capacities include:
- cGMP Master and Working Cell Bank Production (MCB, WCB);
- cGMP Master and Working Viral Seed Stock (MVSS,WVSS);
- DS and DP Production;
- DP Fill and Finish;
- Process intermediate, and final product storage;
- Quality Control/Quality Assurance Services;
- Support Dossier Filing with different Regulatory Authorities.
Process Development Laboratories
A separate 200 m2 laboratory, equipped with all the instruments needed to perform Process Development and Engineering run trials, completes the set of tools and capabilities Advent can flexibly deploy to meet the requests of our clients..
The range of non-cGMP production services and capacities include:
- Research Cell Banks;
- Pre-GMP Viral Seed Stock generation and characterization;
- Toxicology Lot production and filling;
- Upstream and Downstream small scale process simulation;
- Process Development, Engineering runs.
When Advent defined its mission to join the pool of leading companies in adenoviral vaccine manufacturing for Ph I/II clinical trials, it became imperative that it meet the highest cGMP standards, including product quality, purity, process efficiency and robustness. As a result, the incorporation of state-of-the-art equipment was a necessary condition, but not the only one. An experienced, passionate team is a solid cornerstone and plays a fundamental role in all Advent activities.
All Advent team members feature a scientific background formed either through academic or previous pharmaceutical professional experience. Every day, they demonstrates their potential, contributing to a continuously improving process which can be seen in all Advent’s successful achievements.