GBI

What GBI does

GBI (formerly Goodwin Biotechnology Inc., founded 1992) is a privately held, full-service biopharmaceutical Contract Development and Manufacturing Organization (CDMO) headquartered in Plantation, Florida. The company specializes in mammalian cell culture-based biologics manufacturing, providing integrated development, cGMP manufacturing, and regulatory/CMC support for clients developing complex therapeutic products including monoclonal antibodies, bispecifics, antibody-drug conjugates (ADCs), radioimmunoconjugates, exosomes, and stem cells. Its proprietary Single-Source Solution™ platform consolidates upstream cell culture development, downstream purification, bioconjugation, aseptic fill-finish, analytical method development, and regulatory support under one roof. Infrastructure includes a 40,000 sq ft facility with 200L, 500L, and 2,000L single-use bioreactors across three process trains, perfusion bioreactor systems, automated AST GENiSYS C fill-finish, ÄKTA chromatography platforms, and a DEA-licensed Schedule I/II controlled-substance manufacturing capability.

GBI operates a project-based, custom-quoted CDMO business model generating revenue primarily through contract development and cGMP manufacturing services. Pricing is tailored to project stage, scale, and scope, with multi-year contracts typical. The company serves biopharmaceutical and biotech companies (early-stage through commercial), medical and research institutions, and—newly—regenerative medicine customers under Florida's Right to Try legislation. Approximately 90% of revenue is attributed to monoclonal antibody and bioconjugation work, with stem cell manufacturing as a strategic growth line at roughly 10%. Geographic reach covers North America, Europe, the UK, China, Australia, and Canada, supported by an established FDA Drug Master File, 50+ regulatory filings, and 500+ projects completed since inception.

The company is backed by Signet Healthcare Partners following a $26 million private equity investment in 2025 and is led by a recently appointed President & COO (Jesse McCool) and Chief Business Officer (Chandra Kelley). Strategic priorities in 2025-2026 include facility expansion, scaling stem cell manufacturing from 10,000 to a planned 1 million patients per year, and converting recently installed commercial-scale capacity into sustained revenue growth.

Name

GBI

Legal name

Goodwin Biotechnology Inc.

Website

https://gbibio.com

Company type

Private

Founded year

1992

Operating status

Operating

Headcount range

51–100 employees

Short description

GBI is a Florida-based biopharmaceutical CDMO offering integrated biologics manufacturing services—from cell culture development through commercial fill-finish—for companies developing complex therapeutics including monoclonal antibodies, ADCs, and stem cells.

Ownership category

akta.pro rank

Product category

Biopharmaceutical CDMO Services

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Biological Product (except Diagnostic) Manufacturing (325414), Scientific Research and Development Services (5417)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Biologics (mAbs/Recombinant Proteins) CDMO (HLAGABAC)

akta.pro secondary industries

Clinical Trial Material (CTM) Manufacturing & Supply CDMO (HLAGABAK), Drug Substance–Drug Product Integrated CDMO (HLAGABAG), Cell Therapy CDMO (HLAGABAD)

Keywords

• Biopharmaceutical CDMO services
• CGMP biologics manufacturing
• Bioconjugation development
• Aseptic fill finish
• Cell culture process development

Headquarters

HQ city

Plantation

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Contract Development and Manufacturing Services: GBI provides full-service CDMO services for biologics development and manufacturing. Revenue is generated through project-based contracts for process development, cGMP manufacturing, and regulatory support services. Services include upstream processing, downstream purification, bioconjugation, fill-finish, and analytical testing. Pricing is project-specific based on scope, scale, and phase of development.
2. Stem Cell Manufacturing: New line of business growth following Florida's Right to Try stem cell law. GBI manufactures stem cells for regenerative medicine applications including orthopedic injuries, wound care, and pain management. Currently produces enough for approximately 10,000 patients per year, with plans to scale to 1 million patients per year.
3. cGMP Clinical and Commercial Manufacturing: Revenue from cGMP manufacturing of biologics for clinical trials and commercial supply. The company launched its first commercial products in 2023 on behalf of clients. Approximately 90% of revenue comes from monoclonal antibody side, with stem cells comprising 10%.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels7 records

Core offering

GBI is a full-service biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that provides integrated biologics manufacturing services from process development through cGMP clinical and commercial manufacturing. The company's Single-Source Solution™ covers upstream cell culture development, downstream purification, bioconjugation (including ADCs and radioimmunoconjugates), aseptic fill-finish, analytical characterization, and regulatory CMC support for complex biologic therapeutics including monoclonal antibodies, bispecifics, exosomes, and stem cells.

Product overview

GBI (formerly Goodwin Biotechnology Inc.) is a full-service biopharmaceutical CDMO offering an integrated Single-Source Solution™ platform that combines development services, cGMP manufacturing, and regulatory support for complex biologic therapeutics. The portfolio includes core manufacturing services (Upstream Processing/Cell Culture Development, cGMP Cell Banking, DSP Purification Development, cGMP Clinical & Commercial Manufacturing, Bioconjugation, Aseptic Fill & Finish, Stability Testing, and Analytical Method Development), support services (Manufacturing Strategy Development, Project Management, Regulatory & CMC Support, Quality Control & Quality Assurance, Biomanufacturing Planning), and application-focused offerings (Biosimilars/Biobetters, Complex Biologics, Exosome Manufacturing, Stem Cell Manufacturing). The company also offers collaborative services including Cell Line Development and Radiolabeled Antibody Conjugates through strategic partnerships. GBI operates from a 40,000-square-foot facility in Plantation, Florida, supporting clients from preclinical development through commercial manufacturing.

Differentiator

Problem solved

Functional benefit

Brands

• Single-Source Solution: GBI's integrated CDMO biologics services platform covering development through commercial manufacturing.

Products and services

• Upstream Processing Cell Culture Development
• cGMP Cell Banking Services
• DSP Purification Development Services
• cGMP Clinical & Commercial Manufacturing Services
• Bioconjugation Services
• Aseptic Fill & Finish Services
• Stability Testing Services
• Analytical Method Development, Assay Verification, and Characterization Services
• Regulatory & CMC Support
• Cell Line Development
• Stem Cell Manufacturing
• Single-Source Solution™

Quantifiable outcome

• More than 500 projects executed since 1992
• +4 more outcomes

Named customers9 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Seven partnerships are on record, tiered key, innovation, talent development, core and support.

• Tavra BioscienceskeyStrategic or Co-development PartnerTexas-based supplier of bone marrow-derived stem cells to physicians. Partners with GBI to manufacture stem cells. CEO Priya Chordia is working with GBI on stem cell manufacturing and FDA compliance. Tavra plans to move to Florida to be closer to GBI's manufacturing operations.
• BioXtekkeyStrategic or Co-development PartnerPompano Beach, Florida company founded by Dr. Bruce Werber. Purchases stem cells manufactured by GBI and distributes them to approximately 50 Florida doctors. Focuses on orthopedic treatments and regenerative medicine applications under Florida's Right to Try law.
• Florida International University (FIU)innovationStrategic or Co-development PartnerCollaboration with FIU's Department of Chemistry and Biochemistry to develop novel linker universal technology for Antibody Drug Conjugates (ADCs) and other bioconjugates. Based on NIH grant to enhance collaboration between industry and academia. GBI accepts graduate student internships from FIU.
• Barry Universitytalent developmentStrategic or Co-development PartnerGBI personnel sit on the external advisory committee for Barry University's Professional Science Master's Degree in Medical Biotechnology program. The industry advisory board helped design the program to meet biotechnology industry requirements. Students can participate in focused research projects under industrial mentorship.
• Cell Line Development PartnerscoreTechnology or IntegrationStrategic partners for cell line development services. Partners offer proprietary vectors to develop cell lines that can routinely produce over 7g/L in CHO cell lines for IgG1 antibodies. Supports expression of various sequences in CHO, BHK, NS0, HEK-293, or SP2/0 cells.
• Qualified Contract Testing Organizations (CTOs)supportTechnology or IntegrationPanel of qualified assays and outside vendors for biologics testing including viral spiking studies and extended characterizations (intact mass, drug/chelator-to-antibody mole ratio, peptide mapping) requiring equipment such as LC-MS. GBI works with qualified CTOs for specialized testing services.
• Radiopharmaceutical Isotope PartnerskeyStrategic or Co-development PartnerLong-standing collaboration to generate isotopes for chelator-antibody constructs for radiolabeled antibody conjugates used in radio-immunotherapy and radio-immunodiagnostics. Multiple peer-reviewed articles published on this innovative work in prestigious scientific journals.

Scale indicators8 records

Recent moves9 records

Expansion highlights5 records

Broad incumbents

• Catalent Pharma Solutions: Global, large-scale CDMO with broad biologics, cell therapy, and fill-finish capabilities across many sites. Overlaps with GBI's biologics CDMO service lines but at vastly greater scale and geographic footprint; former GBI board member Kent Payne was VP/GM at Catalent.
• Lonza Group: World's largest CDMO with extensive mammalian and microbial biologics manufacturing, cell and gene therapy, and integrated services. GBI's President Jesse McCool previously led facility operations at Lonza; comparable on biologics core but Lonza operates at global, multi-site scale.

Direct peers

• KBI Biopharma: Mammalian and microbial biologics CDMO with cell line development, process development, analytical, and cGMP manufacturing. GBI's CBO Chandra Kelley previously held senior roles at KBI, underscoring overlap in business model, client base, and technical positioning.
• Cytovance Biologics: US-based biologics CDMO offering mammalian cell culture, microbial fermentation, and fill-finish services from clinical through commercial scale. Closely comparable to GBI on service mix, customer segment (early-to-mid-stage biotech), and scale; several GBI leaders (McCool, Schmidt, Keylon) are Cytovance alumni.
• Pfanstiehl: CDMO specializing in high-purity excipients, biologics formulation, and complex carbohydrate/sugar synthesis. Overlaps with GBI on biologics development services and shares senior commercial talent lineage (Kelley was previously at Pfanstiehl).
• BioVectra: Canadian biologics and small molecule CDMO offering microbial fermentation, mammalian cell culture, and fill-finish. Comparable service breadth to GBI including complex biologics and conjugates, though with broader small-molecule capabilities.
• Avid Bioservices: Public biologics CDMO (CDMO/CDMO services) offering mammalian cell culture process development and cGMP manufacturing for mAbs and recombinant proteins. Highly comparable to GBI's mammalian biologics manufacturing focus, with a similar small-to-mid-cap footprint.

Emerging players

• Bionova Scientific: Biologics CDMO providing GMP mammalian cell culture manufacturing, process development, and analytical services. Similar early-stage CDMO profile to GBI with overlapping capabilities and a comparable customer base of small biotechs; McCool also led operations at Bionova.
• Wheeler Bio: Early-stage Oklahoma-based biologics CDMO focused on mammalian cell culture and rapid clinical supply for virtual and small biotechs. Directly comparable to GBI in target customer and emerging scale; GBI's President McCool and VP Schmidt both held senior roles there.

Regional players

• JOINN Biologics: China-based biologics CDMO providing cell line development, process development, and GMP manufacturing of antibodies and recombinant proteins. Comparable to GBI's mammalian biologics CDMO service model, though primarily serving the China/Asia market; GBI's VP of Commercial Operations Schmidt previously held leadership at JOINN Biologics US.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/gbi-bio
• Xx.com/goodwinbio

Compliance11 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles17 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about GBI