U.S. Based Pharmaceutical Manufacturing Campus
$2 Billion investment in additional manufacturing capabilities.
HANS Scientific™ is moving quickly to meet the growing demand for US-based pharmaceutical manufacturing. With on-staff design, build, and regulatory experts, we can build, and secure approval for, new facilities without delay. As a result, HANS Scientific offers a unique combination of speed-to-market and a variety of partnership models that deliver a reliable domestic supply chain as demand for US-based manufacturing grows.
Operational CMO Services
Plant Capabilities
- Integrated, closed loop WFI suite producing high purity (14-18 megohm) water. No holding tanks to clean and risk introduction
of contamination. - High shear, closed loop compounding
- Fully automated line, including Wash, Depyrogenation, Fill, Lyophilization and Capping.
- Automated nitrogen vial purge before fill.
- Automatic loading & unloading (ALUS) system for Lyo chamber increases production efficiency and maintains aseptic conditions. ALUS also protects from high potency substances and accommodates low temperature loading (as required).
- Automated particle scanner for 100% lot inspection of O2 headspace %, closures, defects, particles and other items. Significant time savings versus manual inspection.
- Integrated CIP (clean in place) and SIP (sterilize in place) systems
- Nitrogen generation system onsite to assure purity and supply
- Stability chamber for shelf-life validation
- Biological and material testing labs onsite to expedite lot validation testing
- QA and RA experts on-site
- On-site warehousing and labeling available.
On-Campus support and consulting for:
Engineering
- Planning
- Process design
- Equipment Specifications
- Building Specifications
- Full Print packages
Construction
- Program Management
- Electrical Install
- Plumbing Install
- Infrastructure work
- Equipment install
- Equipment Validation
- Procedures and Processes
- FDA Documentation
- Our facility is ISO 13485:2016 & cGMP compliant as well as FDA & State Registered
Plant Capacities
| Line | Fill Suite / Terminal Sterilization Products | Vials/8hr Shift | 24/7 Operation |
|---|---|---|---|
| Line 1* | Filling WFI or compounded injectables in 2/6/10/15/20/25R Vials | 41,000 | 41,820,000 |
| Line 2* | Filling WFI or compounded injectables in 2/6/10/15/20/25R Vials | 41,000 | 41,820,000 |
* Lines can be operated simultaneously
Versatile Partnership Options for US Based Pharmaceutical Manufacturing
Near Term
- Open production capacity
- On-staff QA & RA experts
- On-site biological lab for validation testing
- Warehousing of finished inventory
Strategic
- JV options on Generics
- Out-License Partnerships
- Private labeling
- On-Staff Design/Build/RA experts for accelerated build