We work with most cell lines used for manufacturing monoclonal antibodies and recombinant proteins, including CHO, NS/0, BHK, 293 as well as murine hybridomas, and all selection systems used with these lines.
We have also worked with several different selection systems such as dhfr / methotrexate CHO, mycophenolic acid/xanthine, and G418 systems. Our experience includes attached or surface dependent as well as suspension culture types.
While we are proud of what we do, we know we can't do it all. That's why we've selectively collaborated with companies that complement our skill sets.
Cytotoxic Antibody Drug Conjugates
GBI has established a collaboration with Coldstream Laboratories to develop and manufacture highly potent, cytotoxic antibody drug conjugates by leveraging GBI’s experience and expertise in bioconjugation. Coldstream Laboratories is a specialty manufacturer of sterile injectable drugs and operates a state-of-the-art parenteral manufacturing facility in Lexington, KY. They specialize in the development and manufacture of highly toxic compounds to produce safe and effective drug products. This is accomplished by employing state-of-the-art mobile isolator technology in their manufacturing facility to provide a physical barrier that protects their staff from toxic substances and encloses products in an ISO Class 5 Environment. Similar fixed isolators are used in their development labs to mimic manufacturing operations and enable formulation and analytical development on toxic substances. Through the use of these high containment isolators, their scientists create and maintain a controlled sterile envelope that enables safe processing of potent drug products including cytotoxic antibody drug conjugates, cytotoxins, steroids, hormones and acutely toxic substances. Coldstream’s scope of services ranges from proof-of-concept through to commercial manufacturing, including product characterization, fill & finish, and lyophilization of cytotoxic materials.
The patents and publications that have resulted from this work, click here.
For more information on the fill/finish experience from Coldstream Laboratories, click here.
Cell Line Development
Our partners in cell line development have more than 20 years of experience with biosimilars and innovative biomolecules, and many of the cell lines they have developed have been used successfully in early and late stage clinical trials.
Through our collaborative partnerships, we can take your gene sequence or cDNA for your recombinant protein, antibody, or hybridoma and engineer a highly productive, stable cell line in CHO, BHK, HEK-293, SP2/0 cells or proprietary third-party systems (GS, ACE, UCOE, PER.C6®, etc.). We also have access to CEVEC Pharmaceuticals’ CAP and CAP-T human cell lines and expression systems as well as to the NRCC pTT5 system for large-scale transient expression projects.
Typically, the cell line development activities will result in the identification of three high-producing stable clones, and 15 vials of each of three (3) cell lines will be created. Then, we evaluate the stability of the candidate cell lines in shake flask cultures for up to fifty generations, and cell growth kinetics and productivity are evaluated every five generations.
In conjunction with our client, we evaluate the data and subsequently select one clone for further development work and the creation of the Research Cell Bank (RCB).
For more information on cell line development, click here.
Radiolabeled Antibody Conjugates
For over 7 years, GBI has collaborated with The Albert Einstein College of Medicine of Yeshiva University, a premier, research-intensive medical school dedicated to innovative biomedical investigation. Projects have included studies on and development of radiolabeled antibody conjugates for radio-immunotherapy and radio-immunodiagnostics for use in pre-clinical and clinical trials. From this innovative work, several articles have been published in prestigious, peer-reviewed journals and patents are pending in the US and other countries throughout the world. For more information on:
The patents and publications that have resulted from this work, click here.
Formed in 2009 as a spin-off of Beckman Coulter, Inc., ImmunoSite Technologies, LLC (IST) offers a full range of contract research (CRO) for immune monitoring, particle testing, and process automation services for biotechnology, pharmaceutical, manufacturing and academic organizations around the world. Fully GLP compliant and based in Fort Lauderdale, Fla., ISTís team has 110 years of rigorous product development experience, has been published over 300 peer-reviewed scientific publications, has authored over 30 U.S. and international patents, and has developed and successfully commercialized over 200 diagnostic (IVD) product reagents, kits and instrument systems. IST is distinguished by its ongoing partnerships with best-in-class clinical trial organizations such as: the Immune Tolerance Network, the Immune Tolerance Institute, and the Imperial College of London-managed CD4 Initiative. This extensive immune monitoring and cell analysis R&D experience qualifies IST scientists to accelerate vaccine, biologic and drug discovery, and to comply with complex and demanding international scientific and governmental regulations.
For more information on the collaboration, please click here
As the established global leader in high performance chelating agent technologies for medicine since 1995, the team at Macrocyclics is dedicated to providing clients with innovative and customized chelating agents and being on the leading-edge of developing new chelation chemistry platforms critical for advancement of diagnostic and therapeutic medicine. Their chelating agent products and services meet the challenges of molecular imaging and nuclear medicine. From basic research to early stage clinical development, Macrocyclics combines an extensive background in chelation chemistry with expertise in medical imaging that can help to meet your goals.
As a way of giving back to the community, GBI participates on the external Advisory Committee for the Professional Science Masters degree in Medical Biotechnology offered by the College of Health Sciences at Barry University. The program was specifically designed with the assistance of an active industrial advisory board to meet specific program requirements and produce graduates that will satisfy the current and future needs of the biotechnology industry in Florida and throughout the U.S. This innovative program is a perfect fit for students who see themselves working in a collaborative environment within the biotechnology sector. The internship component allows students the opportunity to play an active role in a focused research project under the supervision of an industrial mentor in an effort to apply cutting edge principles learned in the classroom to real world problem solving in medical biotechnology.
In order to ensure product purity and integrity, extensive testing is required for each stage of the manufacturing process. GBI offers a panel of qualified assays readily available to expedite product and process development. GBI can also accommodate specific assays transferred from clients and can develop and qualify these assays in accordance with regulatory requirements. Assays that cannot be accommodated using GBI equipment or those that would not be compatible with GBI's facilities (such as viral testing) are contracted to qualified outside vendors.