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GBI Bio

GBI Bio

Biotechnology Research

Fort Lauderdale, Florida 5,247 followers

Your CDMO Partner for On-Time Process Development and cGMP Manufacturing.

About us

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.

Industry
Biotechnology Research
Company size
51-200 employees
Headquarters
Fort Lauderdale, Florida
Type
Privately Held
Specialties
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, and Biologics

Locations

Employees at GBI Bio

Updates

  • 🚀 New Blog Alert! 🚀 In the fast-paced world of biopharmaceutical production, efficiency is everything. From early development to large-scale manufacturing, partnering with the right Cell Line CDMO can make all the difference. John Neville, Ph.D.'s latest blog titled, "Maximizing Efficiency in Biopharmaceutical Production Through Cell Line CDMO Partnerships," explores how GBI Bio's strategic collaborations with CLD partners can benefit your program: ✅ Tailored CLD for Unique Drug Substances ✅ Flexibility and Risk Mitigation in the Bioprocessing Pipeline ✅ Access to Cutting-Edge Technologies and Expertise If you're looking to streamline your biopharma operations, this is a must-read! 🔬💡 📖 Read the full blog here: https://lnkd.in/eG3cbFCm #Biopharma #CDMO #CellLineDevelopmentPartnerships #Biomanufacturing #Efficiency

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  • View organization page for GBI Bio

    5,247 followers

    GBI Bio is heading to the 4th Annual Novel Conjugates Summit! 🏙️✨ As a leading Contract Development Manufacturing Organization (CDMO) specializing in large molecules (antibodies, recombinant proteins, etc.) & bioconjugation, we are excited to connect with industry leaders, scientists, and innovators shaping the future of conjugate therapeutics. Let’s discuss how our cutting-edge capabilities, robust quality systems, and scalable manufacturing solutions can help accelerate your next breakthrough. 📅 Date: March 25th-27th 📍 Location: Boston, MA GBI Attending Members: 🙋♂️ Muctarr Sesay 🙋♂️ Nicholas Filipancic, MBA Are you attending? Let’s set up a time to chat! Send us a message via the link below👇 🔗 https://lnkd.in/gRexfGHw #NovelConjugatesSummit #Bioconjugation #CDMO #Biotech #Pharma #Boston

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  • GBI Bio reposted this

    Many CDMOs say they are "fully integrated". In reality few truly are. Consequently the increasing number of 'complex biologics' we are seeing today often require multiple sites to build one product, each site doing its specific part within a complicated, expensive and sometimes risky supply chain. At GBI Bio we have built as much integration as is feasible at our one site in Florida. We call it our Single-Source Solution™. We do this for specific types of products (for example, antibody bioconjugates) and at an appropriate scale typically required for such products. As a world class CDMO we develop and GMP manufacture both the drug substance and the drug product for clinical trials as well as for commercial needs, right here in Florida. We are eager to work with miRecule, Inc., they are pioneers in this new, cutting edge field of RNA conjugate-based therapeutics. Under this partnership we look forward to supporting them in their groundbreaking work, helping to save lives!

    View organization page for GBI Bio

    5,247 followers

    📢 Exciting Partnership Announcement: A New Era in RNA Therapies 🧬 We are thrilled to announce a strategic partnership between GBI Bio, a leading Contract Development and Manufacturing Organization (CDMO), and miRecule, Inc., an innovator in RNA-based therapies! This collaboration marks a significant milestone in advancing the future of biotechnology. Through this partnership, GBI Bio will leverage its world-class expertise in scalable manufacturing and development of bioconjugates, including Antibody RNA Conjugates (ARCs) and Antibody Oligonucleotide Conjugates (AOCs) to support miRecule with accelerating the production of groundbreaking therapies! Together, we will be at the forefront of providing solutions that have the potential to revolutionize the treatment of serious diseases. 🌟 Key Highlights of the Partnership: - Seamless Integration: A commitment to innovation and quality, ensuring optimal development and manufacturing processes. - Accelerating Timelines: Enhancing the speed and scalability of RNA therapeutics production to meet urgent healthcare needs. - Groundbreaking Advancements: Joint efforts to pave the way for new treatments that could change lives. We are excited to see what lies ahead as we work together to bring novel RNA therapies to the world and improve patient outcomes globally. Click on the link below to read the full Press release on the start of this transformative journey! 🔬✨ 🔗 https://lnkd.in/e6rkNZfx #RNAtherapies #Biotechnology #Partnership #Innovation #Healthcare #Biotech #CDMO #LifeSciences #Pharma

  • View organization page for GBI Bio

    5,247 followers

    📢 Exciting Partnership Announcement: A New Era in RNA Therapies 🧬 We are thrilled to announce a strategic partnership between GBI Bio, a leading Contract Development and Manufacturing Organization (CDMO), and miRecule, Inc., an innovator in RNA-based therapies! This collaboration marks a significant milestone in advancing the future of biotechnology. Through this partnership, GBI Bio will leverage its world-class expertise in scalable manufacturing and development of bioconjugates, including Antibody RNA Conjugates (ARCs) and Antibody Oligonucleotide Conjugates (AOCs) to support miRecule with accelerating the production of groundbreaking therapies! Together, we will be at the forefront of providing solutions that have the potential to revolutionize the treatment of serious diseases. 🌟 Key Highlights of the Partnership: - Seamless Integration: A commitment to innovation and quality, ensuring optimal development and manufacturing processes. - Accelerating Timelines: Enhancing the speed and scalability of RNA therapeutics production to meet urgent healthcare needs. - Groundbreaking Advancements: Joint efforts to pave the way for new treatments that could change lives. We are excited to see what lies ahead as we work together to bring novel RNA therapies to the world and improve patient outcomes globally. Click on the link below to read the full Press release on the start of this transformative journey! 🔬✨ 🔗 https://lnkd.in/e6rkNZfx #RNAtherapies #Biotechnology #Partnership #Innovation #Healthcare #Biotech #CDMO #LifeSciences #Pharma

  • 🔬 New Blog Alert! 🔬 In the world of drug development and manufacturing, effective stakeholder communication can make or break a project. For project managers, it’s not just a skill—it’s the key to ensuring milestones are met and partnerships thrive. Our latest blog, "Mastering Stakeholder Communication: A Project Manager’s Key to Success", Authored by 🙋♀️ Lyndsay Hansen explores: ✔️ The critical role of stakeholder alignment in achieving project goals. ✔️ Proven strategies for fostering managing expectations, reducing risks and collaboration between clients, regulatory, and internal teams. ✔️ Examples of tools to use in order to ensure proper documentation communication for complex CDMO projects. Whether you’re navigating a clinical trial, scaling up production, or managing regulatory timelines, this guide is packed with insights to help you build stronger relationships and achieve seamless project execution. 🔗 Read the full blog via the link below: https://lnkd.in/gS7EdHnC What’s your go-to strategy for keeping stakeholders’ communication aligned and engaged? Let’s discuss in the comments! 👇 #CDMO #ProjectManagement #StakeholderCommunication #DrugDevelopment

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  • 💡 Explore the Blog 💡 “Mitigating Risks in Drug Product Manufacturing: The role of a trusted cGMP CDMO” ✍ Authored by: Aditya Gupta 🎯 In today’s fast-paced pharmaceutical industry, ensuring compliance with cGMP standards is critical to delivering safe and effective drug products. In our latest blog, we dive into the vital role a trusted cGMP Contract Development and Manufacturing Organization (CDMO) plays in mitigating risks and ensuring quality throughout the manufacturing process. 👉 Read more to uncover how strategic CDMO partnerships can enhance efficiency, scalability, and compliance in drug development. 🔗 https://lnkd.in/etj_97aK 💬 Let us know your thoughts—how do you see the role of CDMOs evolving in the pharma industry?

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  • Looking ahead to 2025, we’re excited to continue transforming challenges into opportunities and ideas into impactful solutions. Together with our amazing team and clients, we’re ready to make this year one of groundbreaking achievements in biomanufacturing. Cheers to a New Year filled with health, prosperity, and the spirit of collaboration! Here’s to building a brighter, more innovative future together in 2025!

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