Bio-Concept

Aseptic Fill and Finish

Bio-Concept’s aseptic manufacturing facility meets FDA (Food and Drug Administration) cGMP (current Good Manufacturing Practices) and EU (European Union) requirements for Phase 1 and 2 clinical trial product manufacture. The aseptic fill facility is monitored, controlled and recorded in real-time and serviced with our own WFI (Water for Injection) system. The HVAC (heating, ventilation, and air conditioning) system uses 99.99% efficiency HEPA (High-Efficiency Particulate Absorption) filters and is housed in an easily serviced mezzanine above the fill suite and below our roof, eliminating weather related malfunctions that can be prevalent in the New England region.

The flow of personnel and materials (raw material, in-process and final products and equipment) through our facility has been carefully designed, minimizing contamination and mix-ups, and follows cGMPs (current Good Manufacturing Practices).

With more than 20 years of experience in pharmaceutical research and manufacturing, Bio-Concept Laboratories understands the specific challenges aseptic fill-finish and manufacture presents.

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Locations


United States
Bio-Concept Laboratories, Inc.
13 Industrial Way
Salem, NH  03079
United States, North America

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Production Lines

Bio-Concept Laboratories, Inc.   Aseptic Fill and Finish
Location: Salem, NH, United States
Main Details
Specialization:  Drug Product (Fill/Finish)Drug Product (Fill/Finish)
Dosage Form:  LiquidLiquid
Batch Size:  1-5,0001-5,000
Supported Vial Size:  2 ml2 ml
Supported Vial Size:  5 ml5 ml
Supported Vial Size:  10 ml10 ml
Supported Vial Size:  20 ml20 ml
GMP Level:  Phase I/IIPhase I/II
Biosafety Level:  Not SpecifiedNot Specified
Additional Services
Analytical Services are Not AvailableAnalytical Services
Formulation Development is Not AvailableFormulation Development
Preclinical Manufacturing is Not AvailablePreclinical Manufacturing
Stability Studies are Not AvailableStability Studies
Prefilled Syringes are Not AvailablePrefilled Syringes
Viral Manufacturing is Not AvailableViral Manufacturing
Availability: Contact CMO

Last Update: 18JUN14

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