A Passion for the Patient
While many CMOs entered the biotechnology CMO market as a for-profit organization, Goodwin Biotechnology
has a different heritage. Born from the Goodwin Institute for Cancer Research, one of the first manifestations was the value of blending scientific expertise with a passion for the patient. This fueled a number of promising advancements in the treatment of cancer at the benchtop level. The rigors of scaling up with therapeutics to test that promise, coupled with governmental rules and regulations, fueled an important business decision in 1992, Goodwin Biotechnology, Inc. was born. Since then, we've maintained one key attribute, a focus on the patient. That's what motivates us to do a great job on your project.
What We Do So Well
Goodwin Biotechnology offers a Single Source Solution(TM) with a full range of mammalian cell culture development and manufacturing services ranging from the creation of up and downstream processes sufficient for the manufacturing of proof of concept or toxicology product material to processes for licensed manufacturing.
An integral element of aseptic processing is the ability to monitor facilities and processes for microbial organisms. Goodwin Biotechnology has established procedures for evaluation of all GMP areas and processes to ensure continuous control. Sterility testing on all final vialed products is outsourced to a qualified independent safety testing lab to provide to our clients additional and objective assurance that their products have been manufactured and are safe in accordance with USP and CFR testing requirements. Bacteristasis and Fungistasis is determined the first time a product is analyzed to ensure valid measurement of sterility testing parameters.
Endotoxin is monitored for all buffers and equipment rinses and at defined stages for in- process and final product manufacturing. Total organic carbon (TOC) is also assessed for all water system points of use and equipment cleaning processes to ensure that the equipment and materials used are clean and free of all residues from previous products. Goodwin Biotechnology offers:
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In the biologics CMO niche, Goodwin Biotechnology
was the first to engineer the concept of "full integration", which enables us to work with our clients from Proof of Concept through the manufacture of preclinical and clinical trial products. It a process we termed "GMPnization". In other words, we begin with the end in mind. Regardless of whether you are working on a Translational Medicine project or need a partner to manufacture material for clinical studies, we employ cGMP quality from the initial production step of developing the genetically engineered "production" cell line all the way through scale up and vialing of the final biopharmaceutical product.
Goodwin Biotechnology has an enviable reputation for regulatory compliance and, throughout our history, we have provided superior service for our clients that not only meets, but exceeds their expectations. Towards that end, we have completed over 400 projects for more than 100 U.S. and international clients, and assisted in the filing INDs for client products.
Your Partner for Process Development and cGMP Manufacturing