Jubilant HollisterStier Contract Manufacturing & Services is an integrated contract manufacturer of sterile injectables, ophthalmics, otics and sterile and non-sterile topicals and liquids. Our facilities in North America provide specialized manufacturing services for the pharmaceutical and biopharmaceutical industries. We provide a full-range of support and services to streamline the manufacturing process such as on-site assistance from process qualifications through product release. Experienced Project Managers work with our clients and our expert staff throughout the manufacturing process to ensure that projects are processed efficiently and safely. A Jubilant Pharma Company.
VITAL STATISTICS
Year Founded: 1921
Number of Employees: 800+
Key Personnel: Spokane, WA; Montreal, Quebec
WHO WE ARE
Jubilant HollisterStier is an integrated contract manufacturer of sterile injectables, ophthalmics, otics and sterile and non-sterile topicals and liquids. Our facilities in North America provide specialized manufacturing services for the pharmaceutical and biopharmaceutical industries. We provide a full-range of support and services to streamline the manufacturing process such as on-site assistance from process qualifications through product release.
FACILITIES
Sterile Fill/Finish - Spokane
Phase 1 through commercial sterile injectables and lyophilization
Sterile and Non-Sterile Fill/Finish - Montreal
Commercial sterile injectables, lyophilization, ophthalmics and otics Non-sterile topicals and liquids
SERVICES OFFERED
Fill/Finishing
- Process Development
- Inspection
- Compounding Aseptic Compounding
- Labeling
- Filling
- Packaging
- Lyophilization
- Multiple Storage Conditions
- Terminal Sterilization
- Vendor Qualification
Analytical and Microbiological
- Ultra High Performance Liquid Chromatography (HPLC)
- Stability Storage and Testing (ICH Standards)
- Method Validation
- Qualification of analytical methods
- Finished Product and Raw Materials Testing
- Technical transfer of methods
- Sterility Testing
- Biological Assays
Validation
- Process Validation
- Project Master Plans
- Operational Qualification
- Performance Qualification
- Protocol Writing and Summary Reports
- Component Evaluation
- Project Management
- Installation Qualification
Regulatory
- Formula Regulatory Strategy
- Facilitate Effective Interaction with Regulatory Authorities
- Drug Master File
- Electronic Submissions (eCTD)
- Prepare and Supply a Complete Range of Regulatory Documents
- FDA (CDER, CBER), EMA, PMDA, ANVISA, Health Canada
- Provide Guidance and Expert Review of Regulatory Submissions.
