CORPORATE OVERVIEW
WHO WE ARE
• Small Scale Development
• Scale-up and Technology Transfer
• Clinical Manufacturing and Packaging
• Commercial Manufacturing and Packaging
• Quality Control and Stability Testing
We are a full-service, cGMP-compliant manufacturing and packaging services company serving the pharmaceutical industry in the areas of:
OUR PHILOSOPHY
We seek to maximize our production capacity and our customer’s market share.
We will provide flexible cost-effective
manufacturing services.
We will seek to maximize growth opportunities and profitability for both companies
OUR HERITAGE
Constructed by G.D. Searle (1971 – 1997)
• 101,000 ft2 facility
• 40 Products, 80 SKU’s manufactured at Oakville Site
• Transferred 3 ANDA powder and semisolid products
• Segregated suite produced ¾ billion tablets
• Designated as world-wide clinical supply site
Roberts/Shire (1997 – 2001)
• 20 products, 75 SKU's transferred in 8 months
• Transferred 3 complete manufacturing and packaging work centers
• Designated as outsourcing partner for all North American operations
WellSpring Pharmaceutical/Pharma Services (2001 – Present)
• Establish Contract Manufacturing Services
• 26 products - NDA/ANDA’s /OTC’s
• Solid and Semisolid Development Projects Executed
EXPANDED BUSINESS FOCUS
• Expanded directly scalable capabilities in smaller development scale equipment
• Expertise (Process Development and Clinical Manufacture Phase I & Phase II) that complement our larger scale commercial manufacturing
• Expanded capabilities into specialized dosage forms such as bilayer tablets or “tablet within a tablet”
• Support potential high potency compound manufacturing
• Expand capabilities into larger scale commercial manufacturing
Recent Equipment Acquisition Provide For:
MAJOR CAPITAL EXPANSION PROGRAM
3- Year Capital Investments Include: • Alexanderwerk Roller Compactor
• IMA Precisa Capsule Weight Checker
• 400 kg O’Hara Tray Drying Oven
• Korsch XL400 Tablet Press with Bilayer Module
• Glatt GPCG 2/5 Fluid Bed Processor
• O’Hara Aqueous Film Coating with 18” and 30” Interchangeable Pans
• 5L Becomix Counter Sweep Vessel
Future Initiatives: • Manesty Novapress Tablet Press
• Explosion Resistant Manufacturing Upgrades
• 30-50L Counter Sweep Vessel
• Large 2000-4000 L Counter Sweep Vessel
OUR DEEP EXPERIENCE
• Designated as exclusive North American supply site for major product lines
• Experience with a wide range of products
• cGMP compliant facility FDA & HC approved, EMA accepted
Over 80 client audits since 2001
Extensive experience in providing manufacturing outsourcing services for major product lines to large pharmaceutical companies
2014 Health Canada Inspection
2014 Saudi Arabia Health Authority Inspection
2014 FDA General Inspection
2012 Health Canada Inspection
2010 Health Canada Inspection
2009 FDA General Inspection and PAI
2009 Health Canada Inspection
2007 FDA General Inspection and PAI
2006 Health Canada Inspection
2004 Health Canada Inspection
2002 FDA Systems Based Inspection
OUTSTANDING COMPLIANCE HISTORY
OUR PEOPLE
Total of 122 Employees
Manager, IT Peter Lunde
Chief Financial Officer
Matthew Griffiths
Controller, Pharma Services
Darren Jolley
Director, Quality & Regulatory Affairs
Charles Chee
Manager, Laboratory Services
Dragan Pupovac
Director, Plant Operations
Aaron Polesky
Manager, Maintenance
Pierre Pitre
Manager, Materials Management Mike Rowland
Manager, Manufacturing
Trevor Curry
President, Pharma Services David Mayers
Vice President, Business Development
Sam Ricchezza
Manager, Human Resources Sarah Roth
Executive Director, Business
Development Lonnie Barish
Technical Director, Pharma Services
David Watt
Director, Program Management Dara Caratao
CEO Wendy Shusko
MANUFACTURING STRUCTURE
Processing Operator Basil Bilal
Joel Firmin Winston Malabre
Jose Jessie Dela Cruz Rene Molina
Uldarico Maramo Danta Mangilaya Narendra Pandit Daljeet Panesar
Nesan Nagaretnam Leo Sia
Sunny Joseph Waran Arasaratnam
Dennis Baja Branislav Sesum (c) Leonardo Jocson (c)
Pablo Milanes (c)
Production Mechanic Denis Guite
Kevin Marchand Shawn Cook
Director, Plant Operations
Aaron Polesky
Plant Operations Coordinator
Laurie McIntyre
Manager, Manufacturing
Trevor Curry
Group Leader Cindy McMillan
Packaging Operator Mary Latincic
Denise McDonald Louise McDonald
Claudette McKernan Antonio Omay
Wieslawa Przeracka Vijitha Sivayoganatha
Marg Sobik Astrid Szczesna
Agata Szwed Sangeeta Modgil
Manjula Patel Taruna Lad
Kalpana Vashee Rosalia Tolentino Ewa Cieslicka (c) Jennifer Davis (c) Hanna Pustul (c) Shahnaz Hadi (c) Harjeet Lall (c)
Stephen McMillan (c) Quentin Lendvoy (c)
Lall, Harjeet (c)
Manager, Maintenance Pierre Pitre
Maintenance Mechanic
Gardner Walker
Building Mechanic Stephen Thomas
Sr. Production Mechanic
Gary Knights
Production Mechanic Doug McMullen
Production & Demand Planner
Sandy Clappa
Senior Procurement Specialist
Branka McBride
Manager, Materials Management Mike Rowland
Warehouse Operator Wayne Quinlan Dan Maloney
Bronson Lendvoy (c)
James McKeating (Agency Temp)
Student (Part-Time) Michelle Mesce
Processing Operator Trainee
Nebojsa Papic Nikola Papic (c)
Group Leader Rod Dean
Christian Jimenez Sean Lendvoy Arturo Micu
Processing Operator (Senior)
Balford Grant James Small
Igor Radunovic Scott Everingham
Supervisor, Manufacturing Tanya Madill Sanjoy Datta
QUALITY SERVICES STRUCTURE
Senior Chemist Lauro Carreon
Supervisor, QC Mark Stiene
Chemist Sasha Knezev Mirjana IIic
Carol Shi Magdalena Piekarczyk Tatjana Stojanovic (c)
Hetal Bilimoria (c) Andrea Ma (c) Raajvi Tailor (c)
Microbiologist Hannah Chen
Microbiology Lab Assistant
Kim Miller (c)
Research Chemist Chris Moore
Data Reviewer Hong Zhai
Stability Program Associate
Isabelle Lambinicio
Lab Documentation Specialist
Paul Andersch (c)
Laboratory Systems Specialist
Vladimir IIic
Chemist Ronnie Lu
Nataliya Gorban Ying Zhang
Compliance Coordinator Saido Sheikh
Frances Clarke (PT) Jennifer Nguyen
QS Documentation Coordinator Laura Birch
QA Sampler Pallavi Kolekar
Manager, Laboratory Services
Dragan Pupovac
Administrative Coordinator
Natalie Baricevic
Directory, Quality & Regulatory Affairs
Charles Chee
Senior QA Associate Irene Mesce
QA Associate
Donna Mamaradlo Yasleidy Hernandez-Morales
Ottis Brown (c) Fatemeh Darvish (c)
Group Leader, Quality Assurance
Lorraine Harkness
Laboratory Assistant Lynnette Mangilaya (c)
BUSINESS DEVELOPMENT STRUCTURE
Executive Director, Business Development
Lonnie Barish
Regional Director, Business Development
VACANT
Technical Director David Watt
Director, Program Management Dara Caratao
Vice President, Business Development Sam Ricchezza
Technical Transfer Manager
Norman Fong
Project Manager Michelle Puglielli
Krystyna Chiaravalle
Technical Services Coordinator (c)
Matthew Lambinico-Tieng
Senior Validation Specialist
Barry Knox
Validation Engineer Zhan Yang
Warehouse
Utilities & Services
Topicals & Liquids Manufacturing
Topicals & Liquids Packaging
Quality Control
Solid Dose Manufacturing
Solid Dose Packaging Hall
Quality Control
Admin
Clinical Services
Narcotics Vault
OUR FACILITY
Admin
Technical Services
Algeria Australia Belarus Canada Czech Republic France Germany Mexico
New Zealand Romania Russia Spain Sweden UK USA
PRODUCT DISTRIBUTION
Distribution Countries
SMALL SCALE DEVELOPMENT
• 5L Beco-Mini Lab (manufacture of small scale semi-solids)
• Small scale kettles with mixing capabilities (solutions)
• ILC Dover Containment Hood for working with potent compounds
• T.K. Fielder SP65 High Shear Granulator (small scale high shear granulations)
• Glatt GPCG-2 Fluid Bed Granulator (6L and 12L spray granulation bowls)
• O’Hara Labcoat II Film Coater (18 and 30” interchangeable pans)
SOLID DOSE MANUFACTURING
• Pharma Matrix High Shear Granulators TK Fielder PMA250, SP400 and PMA600 Units
• Glatt Fluid Bed Processor WSG120 (220L & 525L bowls)
• Alexanderwerk WP200 Roller Compactor
• Glatt Bin Blending System 250L, 500L, 1200L and 1800L Bins
• V-Cone Blenders 1 cubic foot
3 cubic foot
10 cubic foot (with Intensifier Bar)
• Fitzmill and Comils
• Thomas Accela-Cota 48” Tablet Film Coater Aqueous Coating Only
SOLID DOSE MANUFACTURING
• O’Hara Tray Drying Oven (2)
• Manesty Tablet Presses Betapress: 16-station, "B" Tooling (2)
Unipress: 27-station, "B" Tooling
Novapress: 37-station, "D" Tooling
• Bosch H&K 1500 Capsule Filler
• IMA Precisa Capsule Weight Checker
• Capsugel Ultra II 8 Capsule Filling Machine
SOLID DOSE MANUFACTURING
• High Shear Granulation and Fluid Bed Granulation/Drying
Batch Sizes: 50 kg to 250 kg*
• Tray Drying Batch Sizes: 5 kg to 400 kg*
• Blending Batch Sizes: 5 kg to 450 kg*
• Tablet Coating Batch Sizes: 90-140 kg (48” pan)*
* Based on a 0.5 bulk density
SOLID DOSE PACKAGING
• Glass and plastic bottles
• PVC/foil and foil/foil blisters
• Induction Seal & C/R Caps
• Fully automated, validated lines
Bottle Descramblers
Slat fillers
Desiccant Placers
Cotton Inserter
Induction Sealers
Cappers
Torquers
Cartoners/Labelers/Shrink wrappers
• Flexible lines
For small scale packaging needs
SEMI-SOLIDS
• Batch size: 120 kg to 500 kg if vacuum required
• Batch Size: 2 to 500 kg if no vacuum required
• Equipment: Molto Mat Universal 500L Mixer
Jacketed Vessels equipped with Prop Mixers
SEMI-SOLIDS & LIQUIDS MANUFACTURING
NON-STERILE LIQUIDS/SUSPENSIONS
• Batch sizes: 30 L to 2,000 L (2 x 1000L)
• Equipment: 70 L – 1000L Jacketed Vessels
2,000 L Liquids Process Tank
100 & 250 L Mixing Tanks
Light Sensitive Products
SEMI-SOLIDS & LIQUIDS PACKAGING
• Tube Filling Line Romaco Unipac Tube Filler
Plastic (Laminate) and metal tubes
Fill Range: 2 g to 227 g
SEMISOLIDS & LIQUIDS PACKAGING
• Jar Filling Line
Fill Range: 25 g to 450 g
• Liquid Filling Line
Fill Range: 6 mL to 1000 mL
Bottle Filing in Glass or Plastic Bottles
Neck-banding and Induction-sealing (most formats and sizes)
QUALITY CONTROL TESTING
• Testing Capabilities
USP Compendial & Non-Compendial Chemistry Testing
Microbial Testing
BP/EP testing available
• Analytical Method Development, Validations and Transfer
• Support of Plant Activities
Cleaning Validation
Process and Packaging Validation
Environmental Monitoring Program
QUALITY CONTROL TESTING CAPABILITIES
• Equipment Capabilities
HPLC (UV / DAD & RI)
HPLC Conductivity
Infra-Red Spectrophotometry
UV / Visible Spectrophotometry
GC-FID
Dissolution Apparatus Type 1 & 2
• Chromatographic Data Software
WatersTM Empower 3
ALL MAJOR LAB EQUIPMENT FULLY PART 11 COMPLIANT
STABILITY TESTING
• ICH Compliant Stability Programs
• Room Temperature and Accelerated Chambers
25°C/60%RH
30°C/65%RH
40°C/75%RH
Validated, Alarmed and on Back-up power
• Photostability
• Protocol and Report generation
QUALITY ASSURANCE
eQMS System Change Control System
Control and Issuance of Master Documents • SOP’s, Test Methods and Specifications, Master Processing
and Packaging Records
CAPA System
GMP Training Records • SOP’s, Test Methods, MPF/P’s
Manual System Non-Conformance Reporting System
Vendor Auditing and Approval
Customer Complaints
Product Release (BPCS)
GMP Training
Quality Control
TECHNICAL TRANSFER PHILOSOPHY
• Project management oversight
• Full analysis of technical package
• Establish technical transfer team
• Create timelines with client input
• Weekly progress meetings
• Technical project plans, protocols and reports generated
• Full client approval of master documents
• Analytical testing support
• Project is considered transferred when validation is completed
CLIENTS WELCOME TO OVERSEE TRANSFER!
INDUSTRY LEADING CLIENT FOCUS
• We know the CMO business and what it takes to be successful
• Strong cGMP compliance record
• Long history of product quality
• Provide responsive personalized service
• Reliable production flexibility and capacity
• Help develop full commercial potential and value pricing
• Continuous improvement culture
WE WILL BUILD A LONG LASTING PARTNERSHIP WITH YOU!
KEY CONTACTS
LONNIE BARISH, MBA Executive Director, Business Development
130 Market Place #244 San Ramon, CA 94583 USA
Office: +1 925-803-1080 Cell: +1 510-305-8910
SAM RICCHEZZA Vice President,Business Development
400 Iroquois Shore Rd Oakville, ON L6H 1M5 CANADA
Office: +1 905-337-4518 Cell: +1 905-334-2478
DAVID WATT Technical Director 400 Iroquois Shore Rd
Oakville, ON L6H 1M5 CANADA
Office: +1 905-337-4519 Cell: +1 647-330-6415