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.
GBI's downstream process development group has well over 50 years of experience in developing and refining purification processes. With an extensive background in the purification of proteins from mammalian, as well as plant and animal transgenic systems, GBI can quickly develop a purification process for clients that will maximize yields for the target molecule, meet required purity levels, and be compliant with the regulatory requirements for product's development status.
GBI has a broad range of experience with the following:
Monoclonal Antibodies, Antibody Fragments (including IgG, IgA and IgM subclasses)
Recombinant Proteins
Growth Factors, Cytokines
Hormones, Enzymes
Antibody Conjugates
Radio-labeled Antibodies
GBI has experience with affinity, ion exchange, hydrophobic interaction, mixed mode, MEP chromatography, and other processes. Our experience includes UF processes using TFF technologies in both flat plate and hollow fiber formats. Viral clearance techniques employed include low pH inactivation and nanofiltration. We work closely with filtration media providers to develop a filtration process that works within the confines of your process and product requirements and provides the necessary viral removal.
To learn how we have developed purification processes to purify high quality, therapeutic grade IgMs, click here.
GMP Manufacturing
As the product proceeds through its clinical evaluation, GBI can optimize and refine the purification process including the testing and establishment of parameter limits. When the product reaches Phase III clinical testing and beyond, GBI will have developed a process that can be transferred for commercial manufacturing and ready for qualification runs with a minimum of problems.
Develop product quality, process economics, and scalability
Resin-reuse (e.g. Protein A column)
Product safety and compliant (e.g., viral inactivation and removal)
Viral clearance studies are managed by GBI using a contract biological safety testing organization. Viral Clearance Studies for early stage clinical trials require two model viruses. For late stage clinical trials, four model viruses are required.
GBI can perform the necessary scale down validation to assure that the process transferred to the testing organization is representative of the full-scale process. GBI can provide an onsite scientist at the testing organization to assure that your process is run according to its requirements to avoid comparability questions on the results. The scale down validation and viral clearance studies are assembled into one package for submission to regulatory agencies or other manufacturers.
Transgenics
Tobacco Plant Transgenics Ask us how we developed purification process for an antibody expressed in tobacco.
Avian Transgenics Ask us how we completed the purification development of a cytokine expressed in egg white.
Bob Boucher Senior Process Development Scientist (Purification)
As a Senior Process Development Scientist at GBI, Bob has been responsible and taken the lead in
process development and technology transfer into GMP manufacturing of most of the recombinant protein and monoclonal antibody projects that have come through GBI over the last 18 years. His responsibilities include transferring of clients’ existing downstream processes into the Process Development group, optimizing and the development and scale-up of new cGMP compliant purification processes, performing conjugation or other post-translational modifications processes, resolving technical problems, facilitating the transition of projects into GMP production, and monitoring of ongoing manufacturing campaigns. He also supervises and trains technicians and PD scientists, and writes Project Plans and Research Reports as well as Master Purification Batch Records. Bob earned a Bachelor of Science degree in Medical Biology at Framingham State College.
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Cheryl Oleski Manager, Downstream Manufacturing
Cheryl is the manager of Downstream manufacturing at GBI where she is responsible for cGMP protein purification, bioconjugation, and Fill & Finish operations.
Her duties include process scheduling for downstream operations, recruiting and training of staff, coordination and control of required documentation and materials, as well as the qualification and implementation of equipment. She has over 20 years of experience in GMP manufacturing monoclonal antibodies, fluorescent dyes, and whole blood control products for major multinational companies. Cheryl earned her Bachelor of Arts degree in Chemistry from Florida Atlantic University.
