Process Development Goodwin Biotechnology’s downstream process development group has well over 50 years of experience in developing and refining purification processes for recombinant proteins. With an extensive background in the purification of proteins from mammalian, as well as plant and animal transgenic systems, Goodwin Biotechnology 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.
Goodwin Biotechnology 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
Goodwin Biotechnology 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.
cGMP ManufacturingAs the product proceeds through its clinical evaluation, Goodwin Biotechnology 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, Goodwin Biotechnology 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 Goodwin Biotechnology 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.
Goodwin Biotechnology can perform the necessary scale-down validation to assure that the process transferred to the testing organization is representative of the full-scale process. Goodwin Biotechnology 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.
Besides being highly efficient on the technical front, Goodwin Biotechnology also offers great client support, ensuring that every client gets the personal attention of senior managers. The fact that Goodwin Biotechnology is small enough to allow this is of great comfort, as the sensitive process development requires that the client and the company keep all lines of communication open in order to achieve success. If you are in search of a company that takes competency, consistency and service delivery serious, Goodwin Technology is the company for the job. Your hand will be held through the entire process, your concerns attended to and at the end of it all, the biotechnology feat that you had hoped to accomplish will be yours to keep. Whether on an individual or corporate basis, Goodwin Technology is available to attend to you.