UNIGEN
Contract development and manufacturing organization focused on large-scale production of recombinant biologics and vaccines. Operates a commercial biomanufacturing facility with Baculovirus Expression Vector System (BEVS)-based production using insect cells, and provides end-to-end services from process development and pilot studies through GMP drug substance and drug product manufacturing, analytical characterization, and regulatory support for domestic and international supply.
Industries
Products
Baculovirus Expression Vector System (BEVS)
A system for producing recombinant proteins using baculovirus vectors in insect cells.
Baculovirus Expression Vector System (BEVS)
A system for producing recombinant proteins using baculovirus vectors in insect cells.
Services
Process development services
Cell line/vector construction, culture method optimization, small-to-pilot scale process development, purification method evaluation, and analytical method development for biologic products.
GMP drug substance manufacturing
Contract GMP manufacture of biologic drug substance including cell bank/virus bank management, clinical and commercial production up to 21,000 L primary culture scale, and associated upstream/downstream operations.
GMP drug product manufacturing and clinical supply
Formulation studies, clinical trial material production, vial filling and primary packaging services with capacity for clinical supply; industrialization of formulation is provided via affiliated formulation manufacturers.
Analytical testing and characterization services
Quality and stability testing, bioactivity and protein assays, mass spectrometry, structural analysis, particle measurement, and sequencing-based assays to support release and characterization.
Process development services
Cell line/vector construction, culture method optimization, small-to-pilot scale process development, purification method evaluation, and analytical method development for biologic products.
GMP drug substance manufacturing
Contract GMP manufacture of biologic drug substance including cell bank/virus bank management, clinical and commercial production up to 21,000 L primary culture scale, and associated upstream/downstream operations.
GMP drug product manufacturing and clinical supply
Formulation studies, clinical trial material production, vial filling and primary packaging services with capacity for clinical supply; industrialization of formulation is provided via affiliated formulation manufacturers.
Analytical testing and characterization services
Quality and stability testing, bioactivity and protein assays, mass spectrometry, structural analysis, particle measurement, and sequencing-based assays to support release and characterization.
Expertise Areas
- GMP biologics manufacturing
- Vaccine production (recombinant, BEVS-based)
- Process development and scale-up
- Analytical characterization and QC for biologics
Key Technologies
- Baculovirus Expression Vector System (BEVS)
- Large-scale stirred-tank bioreactors (up to 21,000 L)
- Fed-batch and perfusion cell culture
- Microcarrier culture