Biopharmaceuticals Drug Substance
We take pride in our extensive expertise and capability in the engineering of drug substance and drug products manufacturing bio-pharmaceutical plants. Aevitas has executed several projects in India and abroad for bulk vaccine manufacturing and fill-finish facilities. Aevitas’s bio-pharma specialists are familiar with containment requirements and handling of products based on their bio-safety levels and have successfully engineered facilities up to BSL 3 requirements.
Aevitas possesses large database and in-depth understanding of process equipment including bio-reactor, fermenter, autoclave, manufacturing vessels, lyophilizer, centrifuges, tangential flow filters, high-pressure liquid chromatography columns, cold rooms, filling line machines, packing lines, isolators and RABS.
Our HVAC and process team has in-depth knowledge to meet the requirement of bio-pharmaceutical projects with all bio-safety containment levels and stringent cGMP needs.
Projects
Fill-Finish and Bulk Vaccine Facilities in Western Europe
A large vaccine manufacturer in Europe engaged Aevitas’s services for setting up new BSL 3 IPV bulk vaccine manufacturing and BCG vaccine fill and finish facility. The mandate included basic and detailed engineering of all disciplines, process integration, cost estimate, procurement assistance. Both projects are EU and WHO compliant.
Multiple Bulk Vaccine and Fill-Finish Projects for a Vaccine Major in Maharashtra
Aevitas collaborated with the client for multiple bulk vaccine and fill-finish projects from 2007 up to 2017. The mandates involved process layout, detailed engineering of utility design, piping, HVAC, electrical and instrumentation for human vaccines facilities. All state-of-the-art facilities are compliant with the standards laid down by MHRA, USFDA, EUGMP and WHO.
Vaccines and Fill-Finish Project in Far-East Asia
Aevitas was engaged to provide process, HVAC, project engineering and coordination support for a large vaccine multinational in Far-East Asia. The greenfield complex had a manufacturing block with drug substance and drug product areas, quality control (QC), quality assurance (QA), administrative building, raw material warehouse, intermediate and finished goods cold storage, and utilities. Other areas in the complex include R&D centre, cafeteria, wastewater treatment, security block and a pump house.
Animal House in Maharashtra
Aevitas has partnered with a large vaccine manufacturer for the engineering of an animal housing facility spread over two floors at the existing facility in SEZ in Maharashtra. It houses guinea pigs, rabbits, mice and rats under controlled environment conditions. The facility provides an ecosystem for day/night cycles through automation of HVAC and lighting etc.
Human Vaccine Manufacturing Facility in Telangana
Aevitas did basic engineering for the G+3 manufacturing block designed for the production of 5 different antigens. The facility was designed to comply with WHO, USFDA and other local regulatory norms. The major process equipment included fermenters, Dyno Mill, Tangential Flow Filtration skid, continuous and batch centrifuges and chromatography skids. The support and utility equipment included autoclaves, dry heat sterilizers, multi-column distillation plants, pure steam generator and kill tanks.
Sterile Product Manufacturing Facility in Maharashtra
Aevitas was involved in basic engineering of a bio-pharma facility comprising of drug substance and drug product for protein-based parentals manufacturing. Aevitas’s scope comprised of conceptualization of manufacturing, clean & black utility and QC/R&D/microbiology blocks. Key process equipment included Lyophilizer, vial filling line, Autoclave, manufacturing vessel, inspection machines, cold rooms, deep freezer, LAF, labelling and packing machine.
Clients
