View
1.472
Download
4
Category
Preview:
DESCRIPTION
Citation preview
“Helping make new drugs happen… at the speed of science ”
“Helping make new drugs happen… at the speed of science ”
Formatech
“Helping make new drugs happen… at the speed of science ”
About Us• Lowell: Wannalancit
• Focused on Formulation and Analytical Development for Biologics
“Helping make new drugs happen… at the speed of science ”
• Pre-Formulation/Formulation Development
• Dosage Form Development• Lyophilization Development• Analytical Development & Validations• Cell Culture Development• Purification Development
Contract Development Services
“Helping make new drugs happen… at the speed of science ”
About Us
ANDOVER• Construction of CGMP
Aseptic Fill/Finish facility began in 2000 in Andover
• CGMP Aseptic Manufacturing suite March 2001
• 35,000 ft2 Facility & ~ 75 Staff
“Helping make new drugs happen… at the speed of science ”
• CGMP Manufacture of Aseptic products for clients in US, Canada, Israel, Australia, NZ, UK, Germany, & Japan.– Materials for Toxicological
testing– Clinical Trials (Phases I, II
and III)
Contract Manufacturing Services
“Helping make new drugs happen… at the speed of science ”
Our Experience
We have assisted clients with projects in all stages of the regulatory
process:• Discovery
• Pre-clinical
• Clinical
• Post Approval
“Helping make new drugs happen… at the speed of science ”
Corporate Objective
• Customer Service, Satisfaction, and Loyalty
• Quality• Productivity/Capabilities/
Efficiency
“Helping make new drugs happen… at the speed of science ”
Our Mission
“Making a Difference”
“Helping make new drugs happen… at the speed of science ”
Our Logo
“Helping make new drugs happen… at the speed of science ”
Our Motto
Doing whatever it takes to build client relationships and ensure repeat business!!!
“Helping make new drugs happen… at the speed of science ”
Our Goal: Meeting Expectations
Corporate• Time-to-
Clinic
• Time-to-Market
Agency• Consistent
Process
• Stable Dosage Form
“Helping make new drugs happen… at the speed of science ”
Our Successes!!•FDA inspected GMP Facility May 2003, July 2005 (No 483’s)• MHRA inspected & letter of EU GMP compliance (1st in the US) (3 times)• 200+ manufacturing clients globally•Synagis® and Humira® Development• High antibody concentration formulations• Orally Bioavailable Peptide in a capsule• Solubilization of Insoluble molecules
•IP Spun off as neuMirRx
Corp
“Helping make new drugs happen… at the speed of science ”
Our Tag line
“Helping make new drugs happen… at the speed of science”
“Helping make new drugs happen… at the speed of science ”
Our Strategic Advantage
• Management Strength and Vision• Manufacturing and Development• Proven Track Record• Strong Global Marketing & Clientele
“Helping make new drugs happen… at the speed of science ”
Contract Services
Out-License Technology
In-License Products
The Golden Key
Management: Vision
“Helping make new drugs happen… at the speed of science ”
PERFORMANCE
“Helping make new drugs happen… at the speed of science ”
Performance
“Helping make new drugs happen… at the speed of science ”
“Helping make new drugs happen… at the speed of science ”
Formatech
Recommended