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

Aseptic Fill Suite	Vials/8hr Shift	24/7 Operation
Aseptic fill of Compounded Injectables in 10/15/20/25R Vials	34,000	34,680,000

Lyophilization Capacity	Vials/Cycle	Annual @ 2 Cycles/Day
25R Vials	12,000	8,160,000
20R Vials	12,000	8,160,000
15R Vials	18,000	12,240,000
10R Vials	18,000	12,240,000

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