Reducing Clinical-Phase Manufacturing Costs
Reducing Clinical-Phase Manufacturing Costs. Pentia D, Gonzalez-Perez M, Fabiano A, Peyser JR, Vicalvi J, Sesay M, and Tingley S. BioProcess International; 2016; 14(11): 44-53
Goodwin Biotechnology Presented at the BioProcess International Meeting
Emphaze® AEX as the Utility Infielder of Your Downstream Toolbox
Garth Cole, MBA
Supervisor, Downstream Manufacturing Operations
Garth has over 25 years of experience in biopharmaceutical manufacturing focusing on managing downstream purification departments at companies such as Baxter Bioscience, Amgen, and Lonza where he has managed, trained, and coached purification teams in purifying commercial and clinical products to satisfy production objectives. Over the last 3 years, he has supervised the Downstream Manufacturing Operations at Goodwin Biotechnology. Garth earned his MBA at the Keller Graduate School of Management and a Bachelor’s degree in Technical Management at DeVry University.
As 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.
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.
For more information on our Purification cGMP Manufacturing services please fill out the form below.