State of the Art
Advanced, Nimble, Efficient
- Located on a 37+ acre land in Cranbury, New Jersey.
- Meets and exceeds cGMP.
- Equipped to produce Class A air, Class 0 water.
- Full stack of process capabilities and knowhow.
- Fully equipped analytical laboratory.
- Facility design and controls optimized for probiotics manufacturing.
- Temperature and humidity-controlled warehouse.
- Redundant infrastructure for continuity of operations.
- Drive-in refrigerated vault
- Entire manufacturing facility is HEPA-equipped.
- Laminar air flow in all process suites, a cleanroom design consideration.
- State-of-the-art HVAC design allows each process suite to be independently temperature and humidity-controlled.
- Comprehensive, facility-wide dust mitigation measures.
- Discrete air handling systems for maintenance and wash areas.
- Continuous, automated environmental monitoring of the entire facility, Total integration into facility BMS.
Total Quality Management
- Deep expertise in method development.
- Standardized laboratory practices.
- Ability to perform stability studies in-house.
- Comprehensive product specification, testing and stability protocols.
- Equipment to handle large and small runs and varying material characteristics.
- Hallmark production flexibility.
- Vendor qualification process.
- Raw material quality and vendor selection as the foundational underpinning of product quality.
- Personnel training.
- Quality processes developed and honed in-house.
- Quality systems and trained personnel to achieve consistent quality.
- Trusted by some of the top brands in the industry for our unsparing focus on product quality.
- Rigorous material qualification, in-process and finished goods tests and checks.
- In-house QC reputed to be one of the toughest.
- Our capacity and hallmark flexibility allows us to react and respond to varying market demand with great agility.
- Capability to keep large raw material and component inventories on hand.
- Continuous automated environmental monitoring.
- Cleanliness and cleanability.
- Global sourcing with our hallmark stringent qualification process.
- Relationships with reputed, trusted vendors.
- Sourcing transparency.
- SOPs, document controls.
From formulation to fulfillment, our comprehensive facility, knowledgeable staff and rigorous process ensure your business has a strong manufacturing foundation and agility to navigate any market conditions.
Thinking ahead and investing in our future is what we do. We have the vision, expertise, resources and commitment to continue to stay ahead of the curve and optimize our value with expansions to our capabilities and facility.