Experience.

Agility.

Speed.

Quality.

When speed, quality, and flexibility matter for every stage of your biotherapeutics project, choose GBI as your CDMO partner.

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GBI is a full-service biopharmaceutical CDMO based in Florida that aims to eliminate manufacturing risk for companies developing complex biologic therapeutics.

Our responsive teams of experts across development, manufacturing, project management, and quality can leverage our many platforms to move your project forward on time and on budget.

With an extensive offering of development services, state-of-the-art manufacturing equipment, and project support, GBI is truly a full-service CDMO biologics partner. Our approach pairs our expert knowledge base with an open mind towards scientific discovery so that together we can develop an optimal way to make our systems work for you and your biologics project, no matter how complex it may be.

End-to-End Biomanufacuring Services - All Under One Roof: USP Cell Culture Development, cGMP Cell Banking, DSK Purification Development, cGMP Clinical & Commercial Manufacuring, Bioconjugation, Aseptic Full & Finish, Stability Testing, and Analytical Method Development, Assay Verification & Characterization.
Biopharmaceutical Manufacturing

Our Single-Source Solution™

GBI’s Single-Source Solution™ offers a wide breadth of integrated CDMO biologics services that are specifically tailored to your needs during manufacturing strategy development. Regardless of your project’s stage, our slate of development and manufacturing services are available to help ensure that your project is completed efficiently and safely.

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Support Services

Manufacturing Strategy Development

GBI’s manufacturing strategy development team will walk you through what needs to be done to keep your project on time, in compliance, and within budget.

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Project Management

Stay in the loop and feel comfortable knowing GBI’s expertise is keeping your project on track with our transparent and proactive approach to project management.

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Regulatory & CMC Support

No matter where in the world you are, GBI brings expert support to help you quickly and effectively move your drug candidates through the regulatory application and review process.

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Quality Control & Quality Assurance

Every one of our departments involved in cGMP manufacturing maintains a quality program that meets that department’s specific needs.

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Biomanufacturing Planning

GBI will review your requirements and share our process development and manufacturing expertise to design the appropriate technical, quality, CMC, and regulatory strategies for your biopharmaceutical candidate.

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Three tier ring decribing GBI Bio's Quality by Design Process: Inner ring: Product Specifications and Performance, Critical Quality Attributes and Characterization,Process Design and Parameters, and Process Design and Performance. Middle ring: Product Knowledge, and Process Understanding. Outer ring: Continuous Improvement, Rsk Assessment, and Life Cyclle Management.
Applications
  • Bioconjugation

    GBI will help you face the unique challenges of producing and fully characterizing biosimilars.

  • Complex Biologics

    GBI is strongly positioned for the growing focus in biopharmaceuticals on the development of complex biologics that allow the targeted delivery of products with multiple functionalities.

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News and Resources

News From GBI

Events

BioTech Showcase: The Investor Conference for Innovators

January 9-11, 2023 San Francisco, CA
News Nov 30, 2022

Goodwin Biotechnology, Inc. Is Now GBI!

Publications & Patents Nov 16, 2022

Vaccines Present a Novel Strategy for Opioid Overdose Prevention

Publications & Patents Oct 26, 2022

Theranostic Manufacturing Solutions

Publications & Patents Oct 26, 2022

Leveraging Experience to Reduce Timelines for IND-Enabling Activities

Press Releases Feb 16, 2022

Goodwin Biotechnology Announces the Appointment of Darrin T. Schellin as Chief Executive Officer

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Careers

Join GBI’s team of dedicated scientists and other talented professionals in Florida as we expand into a larger facility and a bigger future.

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