Team Members: Adam Gross, Tran Pham, Amy Jarvis, Jonathan Chen, Rachel Howden, Kathleen Wang, Nina Bordeaux, Gena Urowksy, Jeffrey Rubinstein, Sunitha Jagannathan, Rajesh Chitta
Faculty Advisors: Deb Chakravarti, Nancy Lape
Sponsor Liaisons: Bruce Eu, Bob Platz

AMGEN
Evaluation of Pre-filled Plastic Syringes as the Primary Container for Therapeutic Proteins
This joint Keck Graduate Institute-Harvey Mudd College project was continued from last year. The main goal was to evaluate the switch from glass to plastic pre-filled syringes. To support the assessment, analytical biochemistry experimental methods were developed to minimize oxygen permeation in plastic syringes. The team also tested various secondary packaging and oxygen absorber systems. The experimental results were strengthened by developing and refining a mathematical model of oxygen permeation through syringe and secondary packages. The technical evaluation was complemented by market research and financial models. Patent research to investigate licensing opportunities and potential infringement are completed.

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Team Members: Calvin Chen, Nate Freund, Luke Powers, Luella Sequeira, Chester Wong
Faculty Advisors: Matt Croughan, Brian Augderheide
Sponsor Liaison: Christine Mendoza

AMYLIN PHARMACEUTICALS
Evaluation of Process Alternatives for a Pharmaceutical Manufacturing Unit Operation
The transition between development and manufacturing for clinical and commercial purposes poses many unique challenges. Manufacturing and facility constraints and other scale-up issues need to be overcome before production can reach a scale adequate to supply clinical trials and/or commercial needs. The objective of this Team Masters Project was to work with Amylin Pharmaceuticals to perform a process investigation and development to define a large-scale and business viable manufacturing process for a new therapeutic candidate. The team focused on the replication of portions of the downstream purification process to examine the feasibility of an alternate unit operation. One challenge was the implementation of a laboratory scaleddown model of the manufacturing process. However, the group succeeded in conducting extensive laboratory experiments to support a recommendation for implementing post-IND process changes. Experimental analysis was supported by SuperPro simulation software, which was utilized to forecast the effects of changes and provide reports to conduct operational and cost analysis.

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Team Members: Asia Chang, Corwin Cole, Jeff Dock, Vincent Eng, Nathan Lee
Faculty Advisor: Jon Lasch
Sponsor Liaisons: Abizar Lakdawalla, Eric Gerber, Mary M. Jotz

APPLIED BIOSYSTEMS
EduLab: A Genomics Education Product Line
Advances in genomics are transforming society in many ways, generating educational and vocational opportunities. Utilizing its resources and building upon past successes, Applied Biosystems (AB) is in a unique position to address the way genomics is taught today and in the future.

The goal of the AB TMP is to formulate a new business model by evaluating growth opportunities in genomic education. Market research was conducted to understand the challenges associated with developing such a business model, while a thorough financial analysis assessed the attractiveness of the opportunity. In addition, product concept development has assisted in the evaluation of consumer acceptance. The results of the TMP will allow AB to critically determine the best opportunities in this sector and identify possible pathways for moving forward. The education market can provide AB with a new consumer base with the potential to improve corporate visibility, drive growth both directly and indirectly, and advance general familiarity with genomics.

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Team Members: Ivy Chen, Justin Hsiao, Helen Liu, Rachel Melman, Steven Weinstein
Faculty Advisor: Molly Schmid
Sponsor Liaison: Bernhard Speiss

BECKMAN COULTER
Business Validation for Development of Molecular Diagnostic Testing
Beckman Coulter is a leading manufacturer of biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes. A new fully automated and integrated molecular diagnostics system is currently under development for labs to perform routine tests critical for clinical decision making and to improve patient outcomes.

The goal of this TMP was to provide analysis of the molecular diagnostics market and to validate requirements of customers for use in routine molecular diagnostic testing. For the analysis of the molecular diagnostics market, the team developed and deployed its own survey among hospital laboratory personnel. This analysis provided quantitative and qualitative descriptions as well as an evaluation of the competitive landscape and market dynamics affecting adoption of new systems. Validation of requirements was conducted via direct contact by interviewing customers in the field. Recommendations were made to assist Beckman Coulter in developing a testing system with respect to identified market drivers and market acceptance.

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Team Members: Tim Friedman, Jeff Liepman, Thomas Quirk, Robert Tapella
Faculty Advisors: Jim Sterling, Animesh Ray
Sponsor Liaison: Betrand Lemieux

BIOHELIX
Commercialization of a Real-Time Compact Isothermal Fluroescence Reader
The BioHelix Team Masters Project developed an isothermal fluorometer system to serve as a platform for nucleic acid amplification technologies developed by BioHelix Corporation. The team worked closely with researchers in the KGI Bioengineering and Microfluidics laboratories to build prototype systems incorporating user requirements defined by BioHelix. These requirements included, but were not limited to:

• thermal stability
• sensitive, multicolor detection
• user-friendly software interface

The team also generated documentation necessary for the transfer of the system to a cGMP manufacturer, and business analyses of the technology and surrounding technologies generated at KGI. The team is delivering a working prototype to BioHelix at the end of the project, which will be used for in-house assay integration. Throughout the development processes, the team worked to overcome both engineering challenges, such as optical system design and thermal control, and business challenges, such as intellectual property, manufacturing compatibility, and commercial considerations.

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Team Members: Adam Miller, M. Cavanaugh-Okeefe, Bala Krishna, Josh Oklan, Parvin Rastegar, Victor Chiu
Faculty Advisor: Angelika Niemz
Sponsor Liaison: Warren Lee

DOW AGROSCIENCES
Optimization of a Testing Method for Genetrically Modified Traits in Maize
Genetic modification is widely used to improve the properties of many crop species, including 61% of the maize planted in the United States. With the prevalence of this technology, it is important to Dow Agrosciences (DAS) to verify that its seed lots are free of any unintended transgenes. DAS must be able to detect one "contaminant" seed among thousands of conventional seeds, where that contaminant seed may contain any one of many different traits. These factors, combined with the large number of lots which must be tested, require the analysis of over 1,000,000 samples per year.

KGI’s team has evaluated improvements to several aspects of the existing DAS assays. At both the DNA extraction and trait detection stages, alternative methods have been tested which improve throughput, reduce operator time, and reduce reagent costs. This assay is automated at DAS and at KGI using Beckman Coulter Biomek liquid handling platforms.

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Team Members: Manjiree Karandikar, Sandeep Lad, Prachi Shah, Andrew Hopkins, Sanket Acharya
Faculty Advisor: Robert Doebler
Sponsor Liaison: Gerard Jensen

GILEAD SCIENCES
RAMAN Wand Technology Project
For purposes of quality control, incoming identification testing of both raw materials and active drug substances typically involves confirmation of molecular identity. The KGI team explored the use of a portable device, based on RAMAN spectroscopy, for rapid identification of incoming raw materials and active drug substances at Gilead Sciences. The advantages of Raman spectroscopy lie in its ability to sample materials inside the packaging outfit, ease of use, and lack of sample preparation. Such testing can be performed by the Quality Assurance group upon receipt of the material, saving members of Quality Control time and associated costs in performing other types of assays.

The team carried out a technical evaluation of the system to assess and optimize performance characteristics, to determine testing and environmental constraints, and analyze generated spectra from given compounds. In addition, the team developed a library of relevant compounds to grade and confirm identity at the point of testing without compromising packaging. Also, the KGI team explored and developed a road-map of the compendial and regulatory requirements for implementation with Gilead commercial products. Possible avenues were discussed with FDA and USP contacts, and referenced with FDA guidance documents. Concurrently, the team developed a scheme to validate the Raman methodology, to enable use with commercial products. The final report creates a pathway for Gilead to use to "Go-live" with this technology for Gilead’s commercial products.

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Team Members: Dan Abramzon, Ravi Amin, Li Chen, Jaime Lau, Kerryann Shemeley
Faculty Advisor: Karen Moynihan
Sponsor Liaison: Terry Dahl

GILEAD SCIENCES
Technology Platforms Database, Enabling the Development of Insoluble Pharmaceutical Compounds
In an effort to maximize the likelihood of success for certain drug candidates, Gilead Sciences’ Foster City formulation group wishes to expand its capabilities for developing insoluble small molecules in oral dosage forms. To this end, the Gilead Foster City TMP team was assigned the task of creating a searchable database of drug delivery technology platforms and providers that specialize in formulating or physically manipulating insoluble therapeutic compounds into oral solid-dosage forms.

The project began with background research to develop a fundamental understanding about oral drug delivery technologies that increase solubility. Secondary industry research was used to generate a list of technologies and vendors that met the scope of the project. Through a process of experimentation, team discussions, and consultations with the team advisor and client, several key parameters were identified as pertinent to evaluating each oral drug delivery company and its technology(s). These parameters included summarizing each technology and all relevant patents and publications, and determining a company’s business development practices with regard to royalty rates and licensing fees. In conjunction with the company evaluations, performance criteria for the searchable database were developed and FileMaker Pro was selected as the database platform. The database was then scripted and developed to meet client specifications including the ability to search by multiple technologies, different physicochemical properties, and specific companies. For the final deliverable, a user-friendly, expandable, multi-search function database containing ~30 drug delivery companies and their respective technology platforms was provided to Gilead Sciences, Foster City.

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Team Members: Pradeep Babu, John McNamara, Ryan Peeler, Senthil Purushothaman, Joanna Kang
Faculty Advisor: Steve Casper
Sponsor Liaisons: Philip Topham, Jill Crussemeyer

LNX RESEARCH
Commercialization Strategies for Pharmaceutical Key
 Lnx Research analyzes scientific communities using social networks to efficiently identify opinion leaders for pharmaceutical and biotechnology companies. Having the right investigators and opinion leaders behind a product has been shown to increase revenues by 18%. Lnx Research specializes in finding key opinion leaders and boosting revenues. The Lnx Research Team Masters Project had many facets:

1. Complete a pilot mapping project
2. Provide a comprehensive technology assessment report
3. Generate pricing scenarios
4. Develop a marketing plan
5. Evaluate product suitability for expansion into underserved areas.

The entrepreneurial nature of the Lnx Research TMP provided significant insight into the workings of a startup company, and the experience will prove valuable in our careers.

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Team Members: Jack Austin, Phyllis Chan, Arun Ravi, Peter Vandeventer
Faculty Advisor: Robert Doebler
Sponsor Liaison: Chris Capaccio

NORTHROP GRUMMAN
Novel Sample Preparation Technologies for Rapid Identification of Pathological Organisms
The Northrop Grumman Team Masters Project (NG TMP) is sponsored by Chemical, Biological, and Explosives Defense Systems at Northrop Grumman’s Electronic Systems sector, located in Baltimore, Maryland. The focus of this TMP is on a subsystem of a handheld biodetection device. Currently within the biotech industry, handheld diagnostic devices for the detection of pathogens are being developed for clinical, point-of-care, and biodefense applications. In particular the NG TMP investigated new designs and methods of rapid sample preparation for the subsequent detection of biological agents. In addition, the TMP surveyed the business and intellectual property landscape of sample prep technologies.

Various milestones were set within the scope of the project in order to have defined deliverables. A preliminary analysis of the business side of sample preparation technology was performed. From market analysis and IP investigations, the NG TMP proposed novel designs to Northrop Grumman for review. Finally, the team gathered laboratory data from designs NG selected for further testing and then built and characterized the final design prototype.

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