Post on 09-Jan-2017
The Choice in Contract Manufacturing
From Concept to Product www.genvion.ca
January, 2015
} Reliable partner and full service provider of product development and contract pharmaceutical manufacturing.
} 45 experienced, highly skilled, professional employees. } Licenced by Health Canada. } Brand new state-of-the-art 80,000 sq.ft cGMP manufacturing and testing
facility. } Located in Winnipeg, Manitoba, Canada.
From Concept to Product www.genvion.ca
} Brand New Facility Built and Completed in 2010
} cGMP Facility that meets FDA, TPD, and EMEA Standards
} Product Development } Manufacturing and Packaging } Quality Control Laboratory } Climate Controlled Warehouse } Shipping and Receiving } Engineering and Administration
From Concept to Product www.genvion.ca
} Product Protection � HVAC optimised environment � Single-pass HEPA air filtration � Closed operation system � CIP system
} Personnel Protection � Use of Isolator as the primary
protection � Isolators designed to achieve 0.1 mcg/
m3 for 8 hours working � Use of Gown as the secondary
protection � Handling of potent materials within
Isolator � Restricted access
} Environmental Protection � HVAC System with HEPA in return � Differential pressure for containment � Decontamination of waste � Isolator exhaust connected with HEP
} Formulation development / optimization (Tablet/Capsules)
} Manufacturing of Feasibility, Registration & Validation Batches
From Concept to Product www.genvion.ca
} Manufacturing of Clinical Trial Material
} Development and/or Technical Transfer Reporting
From Concept to Product www.genvion.ca
From Concept to Product
From Concept to Product www.genvion.ca
} Comprehensive Laboratory Testing
} Method Development and Validation
} Analysis and Profiling Impurities } Dissolution and Drug Release
Profiling } Compendial Method Qualification } Clinical Trial Material Testing } Technology Transferrable to QC
Laboratory } Stability Program Management
From Concept to Product www.genvion.ca
} Rx and OTC solid dosage } Containment dispensing booths } IBC Blenders for dry mixing
From Concept to Product www.genvion.ca
} High shear granulation } Fluid bed granulation/drying } Pilot to commercial scale
From Concept to Product www.genvion.ca
} Tablet compression § Product Development to Pilot Scale
Batches. § Commercial Batches § Bi-layer Capability
From Concept to Product www.genvion.ca
} Encapsulation § Two piece hard gelatin capsules § Fully automated, high speed
encapsulators
From Concept to Product www.genvion.ca
} Tablet coating § Aqueous and solvent based film
coating § Functional coating § Pilot scale to commercial batches
From Concept to Product www.genvion.ca
} Bottle Packaging: § Fully automated packaging line
(80 bottles/min) § Capable of various sizes and
shape format § Equipped with vision system
} Blister Packaging & Cartoning: § Fully automated to
accommodate customers requirements.
§ Equipped with vision system
From Concept to Product www.genvion.ca
From Concept to Product www.genvion.ca
Integrated Vision System for Packages and Components
} Quality control mechanism includes: § Analytical, dissolution and
assay testing § Microbiological testing § Preservative effectiveness
testing § Stability program management
and testing § Validation
From Concept to Product www.genvion.ca
*Annual Volume is based on 2 shifts a day, 5 days a week and 50 weeks a year.
} Current warehouse can hold up to 1000 skids with room for expansion to 5000 skids
} Manufacturing suites currently available to accommodate new equipments on common or dedicated basis.
From Concept to Product www.genvion.ca
Process *Annual Volume (000’s) High Shear Granulation/Fluid-Bed Granulation/Drying
432 Kg
Blending (Dry Powder) 1,152 Kg
Tablet Compression 1,905,120 Tablets
Tablet Coating 422,400 Tablets
Bottle Packaging 12,096 Bottles
Blister Packaging 20,160 Blisters
} High quality, cost effective, reliable and experienced service provider } Formulation and manufacturing services optimized to early clinical stage } Client focused, flexibility and transparency } Scientific expertise and problem solving ability } Dedicated project managers to deliver client projects. } Privately owned, financially secure
From Concept to Product www.genvion.ca
From Concept to Product www.genvion.ca
Quality Control Laboratory Quality Control Laboratory
From Concept to Product www.genvion.ca
Dispensing Booth Blending Suite
From Concept to Product www.genvion.ca
Fully Automated Manufacturing Integrated with HMI System
From Concept to Product www.genvion.ca
Bottle Packaging Line Bin Washing Station
From Concept to Product www.genvion.ca
Air Handling and Humidification Units Water Purification System
Warehouse Vault and Cage in the Warehouse
From Concept to Product www.genvion.ca
GENVION CORPORATION FROM CONCEPT TO PRODUCT
WWW.GENVION.CA