Goodwin Biotechnology Inc.
Karl Pinto -  Chairman
1850 N.W, 69th Ave / Plantation
Fort Lauderdale-33313, United States

Email :dfischer@goodwinbio.com
Website :www.goodwinbio.com
Phone :800-814-8600

Fax :954-587-6378
Our Bioreactors
About

Industry
Chemicals , Pharmaceuticals, Rubber and Plastics
Manufacturer
Description :
Goodwin Biotechnology, Inc. is a fully integrated cGMP contract manufacturing organization (CMO) of monoclonal antibodies and recombinant proteins for preclinical and clinical trials. With over 15 years experience as an independent contract manufacturer, GBI has worked with companies of all sizes from small university spin-offs to major research institutes, government agencies and large established biopharmaceutical companies.
Company Profile

Goodwin Biotechnology, Inc. ("GBI"), based in Plantation, Florida, is the earliest established and one of the most experienced contract manufacturing organizations (CMOs) serving the biopharmaceutical industry.  Originally spun out of the Goodwin Institute for Cancer Research in 1992, GBI's focus has been on the manufacture of pre-clinical, clinical trial products. In the biologics CMO niche, GBI was the first to engineer the concept of "full integration", which enables us to work with our clients from the initial production step of developing the genetically engineered "production" cell line all the way through vialing of the final biopharmaceutical product and distribution to clinical trial sites.  GBI has an enviable reputation for regulatory compliance and has made dozens of clinical trial lots for more than 100 companies through its history. 

In 2004, GBI was acquired by Indian pharmaceutical company, Wallace Pharmaceuticals Pvt. Ltd. (www.wallace.co.in ) based in Goa, India. Wallace is a solid dosage formulations company with an enviable position in the Indian market. 

GBI's senior operational and quality staff have decades of experience in GMP manufacturing. This experience includes work at several leading biopharmaceutical companies. Clients have the assurance of knowing that the individuals entrusted with the manufacture of their products are seasoned industry professionals with excellent track records.

Track Record

GBI is independently listed as one of only 21 major CMOs in the world. GBI has completed over 350 projects and assisted in the filing INDs for client products. The company provides mature, proven quality systems with clinical lots made for U.S. and international clients. Our client base consists of large, mid-sized and small biotechnology companies, medical centers and federal, health and defense agencies

Facilities

GBI occupies a facility of 28,000 sq. ft. which is utilized for GMP manufacturing and process development, QA and QC labs and support services. Manufacturing equipment and its parameters are monitored 24-hour via a computer controlled alarm system. GBI is equipped with emergency backup generators in the event of a power loss. GBI has a facility staff on site to aid in monitoring and maintenance of  manufacturing equipment and its associated utilities.

Services
Employment Opportunities

Management

Karl Pinto
Chairman

Stephanie C. Finnegar
CEO

David Fischer
Executive VP of Client Operations

James Fenno
VP of Regulatory and Quality

Angel Mercado
Director of Manufacturing Operations

Muctarr Sesay
Vice President of Process Development

Mike Cox
Senior Director, Process Developement

Jay Madan
Director, Busines Development

Storm Lefelar
Director, Manufacturing operations

Ellery Mangas
Director, Regulatory and Quality
Why Us ?




Recent Press Releases
Honors

South Florida Manufacturer Association winner

For the year 2002 - awarded in April 2003 by South Florida Business Journal and the South Florida Manufacturers Association

Presence at Linkedin

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