GBI Bio

About

GBI, based near Fort Lauderdale, Florida, is a fully integrated, customer-focused cGMP Contract Development Manufacturing Organization (CDMO) of Biosimilar and innovative monoclonal antibodies, recombinant proteins, vaccines, Antibody Drug Conjugates (ADCs), and other bioconjugates.

GBI offers a wide range of Single Source Solution services, including cell line development, GMP master cell banking, proof-of-concept development, cell culture, purification, and bioconjugation process development, scale-up, GLP pilot manufacturing for Tox animal studies, and cGMP manufacturing with fill & finish for human clinical trials.

These core services are complemented by full support relative to assay development and qualification, analytical and microbiological Quality Control (QC), and Quality Assurance and Regulatory Affairs (QA/RA). With over 20 years of experience as an independent contract development and manufacturing service provider, GBI has worked with organizations of all sizes, from academic research institutions and virtual biotech start-ups to large, established multinational corporations.

Keywords

biosimilars, bioconjugation, monoclonal antibodies, recombinant proteins, cell culture, vaccines, antibody drug conjugates, radioimmunoconjugates, purification, qbd, assay development, process development, gmp manufacturing, cell line development, cell banking, biologics

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