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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.

IST Press Contact:

Marketing Matters

Kyle E. Glass, Public Relations/Marketing Manager

Ph: 502-409-5953

Email: kyle@marketingmatters.net

Web: http://www.marketingmatters.net

GBI Press Contact:

Goodwin Biotechnology

Dave Cunningham, Director of Business Development

Ph: 954-327-9639

Email: DCunningham@goodwinbio.com

Web: http://www.goodwinbio.com

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Dextramers are superior reagents for the detection of antigen-specific T cells, having the ability to interact simultaneously with multiple receptors on a single T cell with unsurpassed avidity. The increased avidity of Dextramers compared to conventional MHC multimer reagents enhances resolution and signal-to-noise ratio providing a more accurate assessment of the T cell response, and clearly identifying responses previous generation technologies might miss.

In compliance with cGLP quality standards, IST specializes in incorporating antigen-specific responses in assay solutions to evaluate the safety and efficacy of vaccines and biologics.  IST offers expertise in confirming the validity of processes involved in such studies. Together with Immudex’s Dextramer™ technology, IST now offers enhanced capabilities to validate the effectiveness of potential vaccines and biologics, and thereby significantly improve the efficiency and cost-effectiveness of drug development and production.

Through the partnership, IST can refer clients that need to gauge T cell response to Immudex, and Immudex can refer clients that have other immune monitoring needs to IST. IST immune monitoring services include custom assay design, optimization, automation and validation; cell mediated immunity; functional immune monitoring and much more. This alliance adds to the capabilities of both companies while streamlining processes – providing for faster, more accurate results for customers. By accurately gauging the effect of an immunotherapy, researchers can reduce a study’s timeline by weeks or even months, and more importantly, can avoid wrong and costly decisions based on weak and inaccurate data. This can prove invaluable during all phases of clinical trials, driving significant cost savings and productivity.

“If you’ve ever been on a conference call with eight separate vendors trying to figure out if a pharmaceutical is working, then you’ll understand why this partnership is beneficial to our industry,” said Wade Bolton, Ph.D., President of IST. “Immudex offers a technology that is superior in gauging T cell responses and we’re honored to call them partners.”

“IST’s standardization, validation and automation of custom assays are the best in the industry,” said Stephen Haley, Ph.D., Vice President and Director of U.S. Operations for Immudex. “This partnership greatly increases our offering capabilities and is poised to be a great asset to our current and future clients.”

The alliance is not an exclusive partnership. IST still has the ability to use other technologies when deemed more appropriate or to meet a client’s request.

For more information on ImmunoSite Technologies, please visit http://immunositetechnologies.com/; follow IST on Twitter at http://twitter.com/ImmunoSite; or follow on Facebook at http://www.facebook.com/pages/ImmunoSite-Technologies-LLC/167604859950599. For more information on Immudex, visit http://www.immudex.com/.

About ImmunoSite Technologies

Based in Ft. Lauderdale, FL, ImmunoSite Technologies, LLC (IST) offers a full range of contract research (CRO) immune monitoring services to leading biotechnology, pharmaceutical, and academic organizations around the world to provide products and services that span all stages of drug discovery and development. IST is rapidly building a worldwide reputation for services related to qualifying, standardizing, and when appropriate, automating assays associated with cell-mediated immunity. By using qualified reagents, controls, standards and processes, IST-developed functional assays perform within tight specifications and yield reproducible results, helping pharmaceutical and biotechnology companies to accelerate drug discovery, document clinical relevance and reduce costs. The IST team has been distinguished by their 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 cell analysis R&D experience qualifies IST scientists to comply with complex and demanding international scientific and governmental regulations.

About Immudex

Based in Copenhagen, Denmark with North American operations based in Fairfax, Virginia, Immudex is the sole proprietor of the MHC Dextramer technology. Immudex develops and commercializes products for the quantitation, characterization, and generation of antigen-specific T-cell responses for life science research, in vitro diagnostics and vaccine development. Immudex has a number of Research Use Only (RUO) products on the market, two products under development for in vitro diagnostic use, as well as a vaccine candidate in development for one of the most deadly of human diseases.

Press Contact:

Marketing Matters

Kyle E. Glass, Public Relations/Marketing Manager

Ph: 502-409-5953

Email: kyle@marketingmatters.net

Web: http://www.marketingmatters.net

The entire IST organization operates with a full quality system compliant with GLP guidelines and relevant international safety regulatory requirements. IST’s “state-of-the-art” facilities for immune monitoring, cell mediated immunity, particle testing, automation, and particle characterization, meet cGLP standards, and are in the process of obtaining CLIA certification.

Key to meeting cGLP standards is IST’s error-free performance standard, based on prevention and a “right-first-time” attitude. This is achieved in numerous ways. First, IST has made a commitment to ensure compliance with all current regulatory requirements. This is accomplished by monitoring changes to regulatory requirements that might impact the various aspects of our business. Routine internal audits of IST facilities are conducted to ensure that we are operating in compliance with regulatory guidelines and our quality program. The IST Quality Management team also manages an extensive instrument qualification, calibration and maintenance program.

“At IST, we take our commitment to quality very seriously because it is central to our work and the value we deliver to our customers. From the management team to every employee and partner, a common and essential shared value is a commitment to providing the best quality management system and training to maintain the highest quality products and services.” Ileana Munoz Antoni, VP, Quality

At IST quality is a must and a pre-requisite for success. Ours is a business of precision and accuracy, reproducibility and specificity, timeliness and trust. These are our real products and services. These are what set IST apart from other contract research and particle characterization companies. These are what our clients require, demand and expect … and IST delivers.

“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” William A. Foster

IST quite literally “wrote the book” on cell analysis testing. That is, they were asked to write a chapter of a book titled Validation of Cell-Based Assays in the GLP Setting: A Practical Guide, by authors/editors Uma Prabhakar and Marian Kelley (Publisher John Wiley and Sons, 2008, ISBN 0470028769, 9780470028766). Chapter 8 of this book is titled: “Intracellular cytokine detection by flow cytometry”, and it was authored by IST scientists Julie G. Wilkinson, Carlos A. Aparicio, and Wade E. Bolton.

Highlights of the IST GLP Program

• Inspection-ready always

• Full Quality Management System

• Regular Internal and External Auditing

• CAPA Program

• Revision-Controlled Quality Documentation System

• Record Retention Program

• Electronic Data Backup/Archive Systems

• Disaster Response and Business Continuity Plan

• Vendor qualification program

• Company QA Unit

• Off-Site Record Archives, Secure and Controlled

• On-Site Record Storage, Secure and Controlled

• Environmental Control & Monitoring

• Equipment Calibration/Certification

• Back up equipment and instruments

• Generator electrical power back up system

• Instrument and equipment acceptance testing

• Instrument IQ/OQ/PQ

• Instrument Point-of-Use QC/QA

• Instrument Performance Monitoring

• 24/7 Security Controlled Access to Facilities

• Employee training

• Operator Qualifications

• EHS Programs for Fed/State/Local regulations

• Chemical and reagent identification and traceability

• Sample chain of custody from receipt to discard/return

• Data traceability to original sample

• Privacy of sample and patient identifiers