Downstream Process Purification Development
GBI has decades of experience and a proven track record in bringing together our development, manufacturing, QA/QC/RA, and purification development teams to develop robust, scalable, and cost-effective protein downstream processes.
GBI’S DSP Experience and Capabilities
We have full downstream protein purification capabilities across many biologics, such as:
- Monoclonal antibodies and antibody fragments
- Complex biologics (including antibody fusion proteins, Fc Fusion proteins, and bispecific antibodies)
- Growth factors
- Antibody conjugates
- Radiolabeled antibodies
- Photo immune and vaccine conjugates
- And other recombinant proteins
We have designed and performed these processes for purification development of non-GMP materials for animal proof-of-concept studies and product characterization. We have also manufactured mammalian cell culture-derived biologics for use in toxicity and animal safety studies as well as first-in-human (FIH) through late-phase human clinical trials.
Our Downstream Process Purification Facilities and Expertise
GBI’s downstream process purification suites are segregated and customized with equipment that specifically meets the requirements of each client’s process in a campaign mode. The experts handling purification at GBI have experience in multiple chromatography and purification techniques including the use of the ÄKTA™ purification system with step and gradient function capabilities for small-scale purification development and the ÄKTA™ ready for process scale-up, large-scale processing of an operating flow rate of up to 500-600L/h of clarified harvest feed stream, tangential flow filtration, and bulk drug substance filling.
We are experts in resin screening and multiple chromatography techniques, including but not limited to affinity, ion exchange, hydrophobic interaction, mixed mode, MEP chromatography, and charged membrane among other processes. Our experience includes UFDF processes using TFF technologies in both flat plate and hollow fiber formats. GBI process development has a proven track record in and strategies for reducing impurities (e.g., HCP) and aggregates.
GBI’s Downstream Process Purification Methods
GBI will perform a Pre-Performance Qualification (PPQ) to develop and optimize processes as well as establish and test parameter limits as your product moves through its clinical evaluation.
As a result of this effort, by Phase III we will have developed a fully characterized purification process that can be transferred for commercial manufacturing and will be ready for qualification runs in our new commercial cGMP facility.
Viral Clearance and Filtration
GBI manages viral clearance studies for product safety and compliance through a contract biological safety testing organization. We work closely with viral filtration media providers to develop a filtration process that works within your process and product requirements to establish and meet or exceed virus removal targets. The viral clearance techniques used include low pH and other chemical inactivations, nanofiltration, and other chromatographic/purification techniques.
We assemble the viral clearance studies into one package with scale-down validation for submission to regulatory agencies or other manufacturers. GBI can perform the necessary scale-down validation to assure that the process that is transferred is representative of the full-scale process. GBI will provide connection to an on-site scientist at the testing organization to keep you assured that your process is run according to its requirements, keeping you from having to face comparability questions when the results are submitted.