Fort Lauderdale, Fla. – November 1, 2011 – ImmunoSite Technologies (IST), LLC, a leading provider of immune monitoring services, has entered into a strategic agreement with Goodwin Biotechnology, Inc. (GBI), a full service Contract Manufacturing Organization focused on process development and GMP manufacturing of cell culture derived biopharmaceuticals, based in Plantation, Fla.
In compliance with cGLP quality standards, IST specializes in confirming the validity of processes in assay solutions to evaluate the safety, immunogenicity and efficacy of vaccines and biologics. Conversely, GBI offers a full range of mammalian cell culture, cell culture and bioconjugation development and manufacturing services. GBI is a cGMP contract manufacturing organization (CMO) and has established robust quality systems to support the manufacturing of materials that can be injected into humans. The partnership provides expanded capabilities for both companies allowing each to outsource appropriate projects across all phases of clinical trials, offering a more streamlined process of developing pharmaceuticals.
“When it comes to developing pharmaceuticals, streamlining processes saves time, resources, and, ultimately, money,” said Wade Barton, Ph.D., president of IST. “Our goal is to help our clients bring pharmaceuticals to market with the highest quality control as quickly as possible. Our partnership with GBI has garnered a trusted name in the industry benefiting both of our client bases.”
“IST’s capabilities in developing and performing cell-based and cytotoxicity assays as well as bioanalytical testing such as flow cytometry was an incredible advantage over others in this field,” said David Cunningham, Director of Business Development for GBI. “GBI and IST can now offer more of a ‘one-stop shop’, which is extremely valuable if you’ve ever had the experience of dealing with several different vendors.”
The alliance is not an exclusive partnership. Both companies still have the ability to use other technologies when deemed more appropriate or to meet a client’s request.
For more information on IST, please visit http://immunositetechnologies.com/; follow on Twitter at http://twitter.com/ImmunoSite; or Facebook at http://www.facebook.com/immunosite. For more information on GBI, visit http://www.goodwinbio.com/.
About ImmunoSite Technologies
Formed in 2009 as a spin-off of Beckman Coulter, Inc., ImmunoSite Technologies, LLC (IST) offers a full range of contract research (CRO) for immune monitoring, particle testing, and process automation services for biotechnology, pharmaceutical, manufacturing and academic organizations around the world. Fully GLP compliant and based in Fort Lauderdale, Fla., IST’s team has 110 years of rigorous product development experience, has been published over 300 peer-reviewed scientific publications, has authored over 30 U.S. and international patents, and has developed and successfully commercialized over 200 diagnostic (IVD) product reagents, kits and instrument systems. IST is distinguished by its ongoing partnerships with best-in-class clinical trial organizations such as: the Immune Tolerance Network, the Immune Tolerance Institute, and the Imperial College of London-managed CD4 Initiative. This extensive immune monitoring and cell analysis R&D experience qualifies IST scientists to accelerate vaccine, biologic and drug discovery, and to comply with complex and demanding international scientific and governmental regulations.
About Goodwin Biotechnology, Inc.
Goodwin Biotechnology is a fully integrated cGMP contract manufacturer of monoclonal antibodies, recombinant proteins and vaccines. GBI has the expertise and experience in cell line development, process development and GMP manufacturing of recombinant proteins and antibodies, as well as conjugated therapeutic proteins (e.g., antibodies conjugated to linkers for
radioimmune therapy and diagnostics, other antibodies, proteins, chemotoxins, or plant toxins) by leveraging our proprietary conjugation technology. By working with GBI, our clients can enhance the value of their product candidates with clear development and manufacturing strategies and a road map to meet product requirements from the milligram, gram and kilogram range as the product candidates move along the clinical approval pathway. With nearly 20 years of experience as an independent contract manufacturer, GBI has worked with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established biopharmaceutical companies.