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.