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
Nr. of Employees
small (1-50)
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
Cell line/vector construction, culture method optimization, small-to-pilot scale process development, purification method evaluation, and analytical method development for biologic products.
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.
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.
Quality and stability testing, bioactivity and protein assays, mass spectrometry, structural analysis, particle measurement, and sequencing-based assays to support release and characterization.
Cell line/vector construction, culture method optimization, small-to-pilot scale process development, purification method evaluation, and analytical method development for biologic products.
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.
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.
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
News & Updates
Manufacturing agreement signed with a vaccine developer for recombinant influenza vaccine drug substance to supply product for the U.S. market; manufacturing activities initiated under the contract.
The manufacturing facility received U.S. FDA approval as a drug substance manufacturing site for an influenza vaccine, enabling production for the U.S. market.
Acquisition of national pharmaceutical manufacturing license for biological products for the Gifu plant, authorizing biologic drug manufacturing under national law.
Completion of Performance Qualification for BEVS-based seasonal influenza vaccine drug substance manufacturing at commercial scale, generating data required for regulatory submissions.
Trial manufacture of seasonal influenza vaccine drug substance using a 21,000 L primary culture vessel at the Gifu facility.
Completion ceremony and commissioning of a large-scale biologics manufacturing plant designed for BEVS- and mammalian-cell-based recombinant protein production.
Manufacturing agreement signed with a vaccine developer for recombinant influenza vaccine drug substance to supply product for the U.S. market; manufacturing activities initiated under the contract.
The manufacturing facility received U.S. FDA approval as a drug substance manufacturing site for an influenza vaccine, enabling production for the U.S. market.
Acquisition of national pharmaceutical manufacturing license for biological products for the Gifu plant, authorizing biologic drug manufacturing under national law.
Completion of Performance Qualification for BEVS-based seasonal influenza vaccine drug substance manufacturing at commercial scale, generating data required for regulatory submissions.
Trial manufacture of seasonal influenza vaccine drug substance using a 21,000 L primary culture vessel at the Gifu facility.
Completion ceremony and commissioning of a large-scale biologics manufacturing plant designed for BEVS- and mammalian-cell-based recombinant protein production.