ADRIANA E. MANZI, PhD
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`Managing Director / Technical Consulting Group
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`adriana@athelnbiomed.com
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`US Cell: 858-405-4584
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`Decisive life science leader with nearly 30 years of experience in R&D of biologics, including biosimilars
`and cell therapies. Successful track record building and managing global, market-competitive, technical
`organizations supporting multiple therapeutic areas, customer audiences, products and services. Expert on
`the structural characterization of complex biologics using physico-chemical methods (i.e. NMR, MS, HPLC,
`CE, and hyphenated techniques). Expert on glycosylation analysis and glycobiology. CMC expert with
`extensive experience on due diligence, technical strategic and operational planning, troubleshooting and
`problem solving.
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`PROFESSIONAL EXPERIENCE
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`ATHELN, INC. (Southern CA based with Global reach)
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` Feb 2010 - Present
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`Founder, President and Managing Director
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`Principal Consultant - Biologics CMC / Analytics / Glycobiology / Technical Strategic Planning
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`Atheln is an innovative biopharma Consulting and Contract Development Organization, specializing in the
`creation of product development and commercial strategies. Commercial and technical disciplines are
`integrated to maximize product value.
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`Atheln has a highly interactive network of consultants, in the US and Europe, in the areas of new product
`planning; biologics cell line, upstream and downstream process development; analytical development;
`CMC; non-clinical studies, Pharm/Tox, PK/PD; regulatory strategy; clinical; quality & compliance; project
`management; domestic and international sales & marketing; business development; and licensing. Atheln’s
`hands-on style ensures effective planning, execution and management of deliverables.
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`Examples of past and present projects include:
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` Responsible for all technical aspects of building a biosimilar portfolio fit to a EU client interest and
`capabilities including the evaluation of 56 potential candidate molecules. Designed the analytical
`comparability packages.
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` Writing CMC Section for US filing of two monoclonal antibodies, one of them biosimilar
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` Conducted analytical package due diligence in Asia for a biologic product to be licensed for the US
`market
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` Review an unfavorable EMA feedback on the glycosylation analysis of a recombinant drug
`substance, designed remediation experiments and addressed the regulatory concerns
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` Global technical due diligence for licensing three biotherapeutic products, focusing on the analytical
`package
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` Evaluation of a recombinant protein comparability after process scale up (mammalian expression)
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` Review and optimization of many physicochemical analytical methods and their validation
`packages for all stages of product development
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`Pharmacosmos A/S v. Luitpold Ex. Pharmaceuticals, Inc., IPR2015-01490
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`Luitpold Pharmaceuticals, Inc., Ex. 2057, P. 1
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` Led Analytical Development efforts, wrote CMC section of IND and continues to advice on a novel
`chimeric antibody-like molecule (fusion protein) for the treatment of angiogenesis-related diseases
`that successfully completed Phase I clinical trials and is now on Phase 2 for its use in wet AMD.
`This included the evaluation of the impact of carbohydrate changes on the in vivo biological activity.
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` Conducted and provided resolution to several OOS investigations
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` Leader development team for a novel oncolytic virus platform
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` CMC advisor for a nanoparticle delivery technology platform
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` CMC advisor for the development of an engineered FGF-1 expressed in bacteria and targeted to
`corneal dystrophies
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` CMC advisor for the Cystinosis Research Foundation for the development of a new delivery
`technology and a cell therapy suited for the treatment of this orphan metabolic disorder
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` Head of QA for a virtual company conducting Phase 2 clinical studies in wet AMD for a fusion
`protein with a novel MOA
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` Member Scientific Advisory Board for a Global Biologics CMO/CRO organization. Role: Analytical
`technologies
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`Led technical team, including CMC, non-clinical, clinical, and regulatory disciplines, in the
`preparation of a strategy and a FIH to Phase 2 development plan for one API in three forms of
`administration for four indications.
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` Evaluated LCM (Life Cycle Management) technical opportunities for immunoglobulin products
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` Advised on all CMC topics and prepared CMC Section of IND for a humanized IgG1 kappa
`immunoglobulin for treatment of PNH expressed in mammalian cells
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` CMC advisor and lead of technical team (non-clinical, clinical, regulatory disciplines) for a synthetic
`glycolipid immunotherapy for solid tumors
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` Prepared CMC section of pre-IND briefing package for an allogeneic human platelet-derived topical
`ophthalmic solution for dry eye
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` CMC due diligence of an oncology cell therapy approach on Phase 3 clinical development in
`support of investment group
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` CMC due diligence in Europe for a allogeneic cell therapy to be licensed for the US market
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` CMC due diligence for a nanoparticle delivery technology platform in support of lead investor
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` Technical due diligence on a new equipment for evaluation of protein aggregation in support of
`investment group
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` Reviewing CMC section of a biologic BLA
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` Design of a CMC strategy for a new type of monoclonal antibody-like platform
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` CMC lead investigator for a University technology transfer group assessing a 10-year development
`program of a biologic for multiple therapeutics indications which license had been canceled
`
` Led GAP analysis team (CMC, biology, non-clinical, clinical, regulatory) for the development plan
`of a novel, first-in-class, small molecule therapeutics targeting cancer stem cells (CSCs) in the
`central nervous system (CNS)
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` Led the team (CMC, non-clinical) conducting GAP analysis and writing a SBIR application for the
`development plan of small molecule thyrotropin (thy) receptor (thyr) agonist for thyroid cancer
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` Designed Quality Systems for two virtual companies in the ophthalmic area, one virtual company
`in the stem cell area and three virtual companies dedicated to small molecule oncology products
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` Advisor to two biologics CMOs with operations ranging from process development and Phase I
`clinical production to commercial production
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`Pharmacosmos A/S v. Luitpold Ex. Pharmaceuticals, Inc., IPR2015-01490
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`Luitpold Pharmaceuticals, Inc., Ex. 2057, P. 2
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` Expert witness in a case related to production of a recombinant protein in bacteria
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` Global market analysis of technical capabilities of fill & finish operations and manufacturers of state-
`of-the-art analytical technologies
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` Conducted many GAP analyses of product development and manufacturing compliance in
`preparation for filing, licensing and acquisition
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` Conducted international audits of several biologics CMOs / Contract Laboratories
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`MANZI & ASSOCIATES (San Diego, CA)
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`Jun 2006 – Feb 2010
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`President & Principal Consultant
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`Provided technical consulting services for research and development of biologics, including all aspects of
`CMC, for all stages of development.
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`Accomplishments included:
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` Acted as VP Product Development for virtual company up to successful IND filing and phase 1
`clinical trial for an autologous therapeutic dendritic cell vaccine for refractory prostate cancer
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` Built the Quality System for two virtual companies, including writing SOPs, batch records,
`specifications, etc.
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` CMC management for production of a fusion protein in BHK cells
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` Revision of the CMC section of a BLA for a transgenic protein
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` Revision of a CMC section of the IND of two gene therapy products – expressed in E. coli
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` Qualification of five CMOs and auditing of over 10 other sites in the US and EU
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` Quality aspects of the manufacturing of stem cells treatments
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` Advice on analytical methods development and validation for FDA compliance covering diverse
`recombinant and fusion proteins and cell therapies
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` Writing of seven CMC sections
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` Set up of specifications for five drug substances and drug products
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` Design of four stability studies for recombinant proteins
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` Design of comparability studies for a recombinant protein and a gene therapy after process
`changes
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`International due diligence for recombinant and transgenic proteins, including risk analyses for
`planned EMEA and FDA filings
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` Supported a regulatory group with CMC advice in formulation development of a malaria vaccine,
`new formulations for biosimilar low molecular weight heparins and antibiotics
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`BAXTER HEALTHCARE CORPORATION (San Diego, CA / Round Lake, IL)
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`1998 - 2006
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`Senior Director - Corporate Tech Resources / Member, Leadership Team
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`Senior Director, Research – Corporate Tech Resources
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`Technical Director
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`2004 – 2006
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`2003 – 2004
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`2001 – 2003
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`Acted as a global consultant to all Baxter divisions and business units.
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`Responsibilities / Accomplishments included:
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` Chemistry of small molecules and biomolecules, including support of life cycle management
`(Factor VIII, plasma derived and recombinant, Advate®) and new developments (Factor VIIa) of
`Baxter’s coagulation products, testing of polysaccharide vaccines, modernization of testing related
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`Pharmacosmos A/S v. Luitpold Ex. Pharmaceuticals, Inc., IPR2015-01490
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`Luitpold Pharmaceuticals, Inc., Ex. 2057, P. 3
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`to polysaccharides used in renal dialysis and solving an investigation related to their recall in
`Europe due to anaphylactic reactions (icodextrin/Extraneal®) and development of an analytical
`platform for LMWH (low molecular weight heparins).
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` Technical strategic planning for Baxter biosciences, renal, medication delivery, and cell therapies
`businesses, including support of discussions with regulatory authorities and preparation of CMC
`sections for submissions.
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` Analytical consulting and problem solving spun to all US (AK, CA, FL, IL, NC, NJ, Puerto Rico) and
`European Baxter large manufacturing sites as well as the plants in Singapore, Mexico and
`Colombia and smaller support operations distributed Worlwide.
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` Major accomplishments included: Solving technical problems at manufacturing sites of raw material
`suppliers that impacted Baxter products. One such endeavor resulted in $75 M savings to Baxter
`and received a Corporate Award in 2006.
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` Successfully designed and executed the CMC for two biopharmaceutical programs with
`development plans spanning 10 years. Led the analytical function for key programs such as
`Epoietin Omega (15 team members; >2M/year budget). These projects included extensive
`comparability studies of recombinant glycoproteins, including a biosimilar product.
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` Built a team dedicated to state-of-the-art analysis of biomolecules new to Baxter addressing the
`growing biopharmaceutical business. The Biotechnology Analytics team was designed based on a
`gap analysis and long-term strategic planning spanning the areas of biochemistry, bioseparations,
`bioanalytical support of PK/TK studies, mass spectrometry and NMR (60% members with PhD,
`20% MS and 20% BS degrees). The instrument park included: twelve regular, micro and Nano
`HPLC systems with UV-Vis, radioactive, fluorescence, RI, MALLS, and ELSD detectors; three CE
`units with UV and fluorescence detection, one linked to MS; three MS systems (LCQ, TSQ and
`LTQ), peptide sequencer; pressure cycler; two NMR spectrometers at 400 and 600 MHz including
`cryoprobe and MAS probe as well as robotics for sample preparation and analysis. All activities
`were conducted in compliance with GLP and cGMP practices.
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` Built a team dedicated to the analysis of PK samples by chromatography and LC-MS. These were
`all small molecule API from approved products that were reformulated for optimized sustained
`delivery. Work included the development and validation of analytical methods as well as
`transferring them to different global testing sites.
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` Deployed biotechnology analytics capabilities across Baxter divisions worldwide making significant
`contributions supporting due diligence efforts, setting-up the methods required for the analytical
`comparability of recombinant glycoproteins, analysis of complex polysaccharides for the renal and
`vaccines markets, supporting the optimization of cell-culture processes, developing and validating
`specific stability-indicating analytical methods for biomolecules, supporting preclinical studies in a
`variety of animal models as well as clinical studies, performing metabonomics by NMR and setting
`up PAT (process analytical technologies) for biologics. These efforts were rewarded with a
`Corporate Award in 2004.
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`NEXTRAN INC. (San Diego, CA)
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`Technical Director
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`Associate Director, Analytical Development/Quality Control
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`1999 - 2001
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`2000 - 2001
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`1999 - 2000
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`Nextran, an affiliate of Baxter Healthcare Corporation, was at the forefront of xenotransplantation research.
`Nextran had a GMP farm to provide transgenic pig organs for human transplant. Research and
`development was under way to suppress the immune response to such transplants. Responsibilities
`included:
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` Selected analytical platform and designed analytical methods development and validation
`protocols. Led a team of four scientists (M.S. and B.S. degrees) in protocol execution. The
`molecules being tested included:
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`Pharmacosmos A/S v. Luitpold Ex. Pharmaceuticals, Inc., IPR2015-01490
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`o Oligosaccharides and the small molecule raw materials used in their manufacturing
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`o Polymers (PEGS) used as carriers of such oligosaccharides
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` Prepared Drug Master Files
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` Supported manufacturing, troubleshooting and solving problems for the cGMP production of
`recombinant enzymes in mammalian, yeast and bacterial cell culture and for the synthetic
`chemistry operation.
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` Led the Quality Control Department of the cGMP facility: managed stability programs; set up
`specifications for raw materials and products; selected and audited contract laboratories; led in-
`house reference standard program, including design of qualification packages and CoAs.
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`CYTEL CORPORATION (San Diego, CA)
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`Associate Director, Analytical Development
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`1998 - 1999
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`Cytel was a biotechnology company in the carbohydrate field that developed a technology for chemo-
`enzymatic synthesis of complex carbohydrates. This technology allowed for the first time the cost-effective
`commercial production of carbohydrate pharmaceuticals as well as others for the food and cosmetics
`industries.
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` Optimized and modernized the analytical development department in preparation for NDA
`submission: hiring and training personnel (MS and BS degrees); equipment selection, purchasing
`and validation (i.e. HPLCs, detectors, LC-MS, preparative HPLC); establishing a program for the
`purification and testing of in-house reference standard candidates; writing departmental SOPs, etc.
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` Built the analytical component of the CMC section for Cytel’s leading drug candidate (a substituted
`octasaccharide) in a record eight months. This included the designed and supervision of the
`development of new methods for raw materials, key intermediates, bulk drug substance and final
`vialed product.
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` Set up specifications for oligosaccharide products and raw materials
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` Led the development and validation of analytical methods
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` Designed stability studies and evaluated their results
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`UNIVERSITY OF CALIFORNIA SAN DIEGO
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`Department of Medicine (San Diego, CA)
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`Assistant Adjunct Professor, Medicine
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`Director, Glycobiology Core Facility
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`Visiting Scholar, Cancer Center
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`1986-1998
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`1991 – 1998
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`1991 – 1998
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`1986 – 1989
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`Acted as Principal Investigator in projects studying complex carbohydrates of biological significance,
`collaborating with a multidisciplinary group of researchers (physicians, biologists, biochemists, etc.).
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` Developed original approaches for the characterization of carbohydrates in biomolecules
`(glycoproteins, glycolipids, polysaccharides, glycosaminoglycans in heparin and LMWH, GPI-
`anchors, etc.) by physicochemical methods, including a variety of HPLC techniques, LC-ESI-MS
`and NMR.
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` Developed a strategy for the parallel isolation of all classes of glycoconjugates from cells and
`tissues. Worked extensively with a variety of cell cultures and mammalian tissues (rat, mouse,
`human).
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` Chemistry leader in 15 different research projects in parallel. Provided strategic planning for
`successful analytical results to those multidisciplinary projects.
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`Pharmacosmos A/S v. Luitpold Ex. Pharmaceuticals, Inc., IPR2015-01490
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` Established the Glycobiology Core Facility, a unique service at UCSD providing analyses ranging
`from a simple monosaccharide composition to NMR analysis of complex carbohydrates. The
`Glycobiology Core Facility successfully served between 1993-1997 investigators at UCSD, UCI,
`UCLA, La Jolla Cancer Research Foundation (currently, The Burnham Institute), Scripps Research
`Institute, Univ. of Michigan, Purdue Univ., Albert Einstein Univ., Washington Univ., Georgetown
`Univ., Duke Univ., Univ. of Wisconsin. Services were also provided to the private sector (Cytel,
`Millipore Corporation, Corvas International, Biosource, Advanced Magnetics, Lyon & Lyon, Kanda
`Medical-Biotech Center).
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` During this period, and as member of the Carbohydrate Analysis Research Committee of the
`Association of Biomolecular Resource Facilities, participated in the design of national studies with
`the goal of standardizing the analysis of carbohydrates.
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`TEACHING EXPERIENCE
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`Invited Instructor: “Carbohydrate Chemistry: Understanding Glycan
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`2008 - 2010
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`Structures and Their Analysis”, IBC Professional Training Academy
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`(San Francisco / Boston / on-line)
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` Lecturer, “Glycobiology” Graduate Course, Department of Chemistry, SDSU
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`2000 - 2003
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`Invited instructor, “Stability-indicating analytical methods”, UCSD Extension
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`Invited instructor, “Analytical Compliance”, UCSD Extension
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`Assistant Professor, Glycobiology Program, UCSD
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`Trained eight postdoctoral fellows and four graduate students,
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` Assistant Professor, Molecular Glycobiology, UCSD
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`1999
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`1998
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`1993 - 1998
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`1993 - 1998
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` Visiting Professor, “Protein glycosylation, oligosaccharide structure, biosynthesis
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`1995
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`and signaling”. Graduate Program in Macromolecules and Cellular Structure
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`and Chemistry, Scripps Research Institute
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`Instructor. Polymer Chemistry. Department of Organic Chemistry,
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`1989 - 1990
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`FCEyN, UBA, Argentina
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`Instructor, Organic Chemistry, Analytical Organic Chemistry,
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`1982 - 1986
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`Structural Analysis of Polysaccharides and Glycoproteins, Admission Course,
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`FCEyN-UBA, Argentina
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` Teaching Assistant, Department of Organic Chemistry, FCEyN-UBA, Argentina
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`1976 - 1982
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`EDUCATION
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` Postdoctoral studies, Biochemistry & Glycobiology, Cancer Center, Dept. of Medicine, Univ. of
`California San Diego, 1986-1989
` Postdoctoral studies, NMR Spectroscopy, Univ. of Bs As / Varian Inc Palo Alto, CA, 1985
` PhD in Organic Chemistry, Suma cum laude, University of Buenos Aires, Argentina, 1984
` B.S. in Chemistry, Specialty (MS) Industrial / Food Sciences, Univ. of Buenos Aires, 1979
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`CONTINUING EDUCATION
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` Leadership Development Program (LDP), Center for Creative Leadership, Jan 2005, La Jolla, CA
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` Advancing Business Performance, Lake Forest Graduate School of Management, Illinois, 2003
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` Program on Negotiation for Senior Executives, Program on Negotiation, a Harvard University-
`MIT-Tufts University consortium, Dec 2001, Boston, MS
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` Dealing with Difficult People and Difficult Personalities, Program on Negotiation, a Harvard
`University-MIT-Tufts University consortium, Dec 2001, Boston, MS
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` Leading Change from the Frontline, Baxter, 2001
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` Resolving Conflict through Problem Solving, Baxter, 2001
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` Entrepreneurship and Innovation, UCSD Extension, Winter Quarter, 1999
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`LANGUAGES
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`English, Spanish, French (reading and writing)
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`BIBLIOGRAPHY
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` More than fifty publications regarding organic chemistry, analytical chemistry, carbohydrate
`chemistry, and glycobiology (see details under Publications below)
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` Over 50 presentations in international conferences and attendance to over 100 conferences
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` Over 15 invited lectures in the last 12 years
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`Pharmacosmos A/S v. Luitpold Ex. Pharmaceuticals, Inc., IPR2015-01490
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`Luitpold Pharmaceuticals, Inc., Ex. 2057, P. 7
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`AWARDS AND HONORS
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`ADDITIONAL INFORMATION
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`1997 - 1998
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`1996 - 1998
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` NIH PO1 HL5734501. Role: Oligosaccharide Analysis Core Director
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` Harold and Leila Mathers Foundation Award. Title of Project: "Analytical
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`technology development: A vital imperative for glycobiology". Role: Co-P.I
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` NIH 1 S10 RR10469. Purchasing of 500MHz NMR Spectrometer. Role: Co-P.I
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`1996 - 1997
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` NIH 5PO1 CA58689. Role: Glycobiology Core Director
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` NIH NCI. Cancer Center Support Grant. Role: Glycobiology Core Director
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` NIH Minority Supplement (MIS-0951) to parent grant (CA38701)
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` Academic Senate Award. Title of project: "Sulfated and Methylated Sialic
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`1993 - 1998
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`1993 - 1998
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`1993 - 1995
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`1993 - 1994
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`Acids", UCSD
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` Fellowship, State of California Program in Biosciences and Biotechnology
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`1987 – 1990
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`OTHER ACTIVITIES
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`2014 – Present
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`2013 – 2014
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`2012 - 2013
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` 
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` Member of the Scientific Advisory Board, Patheon Inc.
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` Member of the Scientific Advisory Board, Gallus Biopharmaceuticals Inc.
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` Member of the Scientific Advisory Board, Laureate Biopharmaceutical
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`Services, Inc.)
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` Member of the Advisory Board, Bioprocess International
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`2008 - Present
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` Domain expert for the Springboard Program at CONNECT
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` Co-leader, Workshop on “Emerging Technologies”, WCBP 2007
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` Member, NIH review committee, grant applications for “Centers for
`Genomics and Proteomics”
` President, Executive Committee, Southern California Section, AOAC
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`Journal Reviewer: JACS, Journal of Agricultural and Food Chemistry
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` Member, Carbohydrate Analysis Research Committee, ABRF
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` Member, Scientific Advisory Board, Department of Chemistry, San Diego
`State University
` President, Executive Committee, Southern California Section, AOAC
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` Secretary, Executive Committee, Southern California Sub-Section, AOAC
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` Member, Executive Committee, Southern California Sub-Section, AOAC
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` Chair, Carbohydrate Analysis Research Committee, ABRF
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`2007
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`2003
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`2003 - 2004
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`2003 - 2004
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`2002 - 2004
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`2001- 2003
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`2001- 2003
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`2001 - 2003
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`2000 - 2001
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`1999 - 2000
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`1998 - 2002
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` Member NIH Site Visit Team to the Complex Carbohydrate Research Center,
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`1998 & 1999
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`Athens, GA
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` Co-chair, Carbohydrate Analysis Research Committee, ABRF
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`1997 - 1998
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` Member, Organizing Committee, 18th International Carbohydrate Symposium
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`1996 - 1998
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`
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`Journal reviewer: Cancer Research; Biochemistry; Analytical Biochemistry;
`J. Lipid Research; Nature; FEBS Letters; J. of Clinical Investigation;
`J. of Immunological Methods
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`1993 - 1999
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` Member, Carbohydrate Analysis Research Committee, Association of
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`1994 - 1997
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`1995
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`1992 - 1994
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`1996
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`1992 - 1999
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`2011 – Present
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`2001 – Present
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`1986 - Present
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`Biomolecular Resource Facilities
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` Co-chair, Third International Glycobiology Symposium
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` Editorial Reviewer: Current Protocols in Molecular Biology
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` Book Reviewer: Analytical Biochemistry
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`
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`Journal Reviewer: Cancer Research, Biochemistry, Analytical Biochemistry,
`J. Lipid Research, Nature
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`MEMBERSHIP IN PROFESSIONAL ASSOCIATIONS
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` American Association of Pharmaceutical Scientists (AAPS)
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` California Separation Sciences Society (CaSSS)
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` American Chemical Society (ACS)
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`PUBLICATIONS
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`ORIGINAL RESEARCH ARTICLES
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`1. Capelleti, C.I., Navarro, D., Manzi A.E., Stortz, C.A,.and Cerezo A.S., Weak-bond linked components
`of the reserve and fibrillar cell-walls of the endosperm of Gleditsia triacanthos. (Leguminosae)
`ARKIVOK, 12: 62-75, 2005.
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`2. Stephen D. Huhn, Christina M. Szabo, Gerome H. Gass and Adriana E. Manzi, “Spatial Mapping of
`Normal and Hypertensive Rat Tissues by hrMAS-NMR Spectroscopy and Metabonomics”, Analytical
`Chemistry and Biochemistry, 2003, Anal Bioanal Chem, 378: 1511-1519, 2004.
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`3. Guerard W. Byrne, Alexander Schwarz, Joanna R. Fesi, Patrick Birch, Ivona Bakaj, Margaret A.
`Velardo, Cong Jiang, Adriana Manzi, Howard Dintzis, Lisa Diamond, and John S. Logan, “Evaluation
`of different -galactosyl glycoconjugates for use in xenotransplantation”, Bioconjugate Chemistry, 13:
`571-81, 2002.
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`4. Zhong, L.T., Manzi, A., Skowronski, E., Notterpek, L., Fluharty, A.L., Faull, K.F., Masada, I., Rabizadeh,
`S., Varsanyi-Nagy, M., Ruan, Y., Oh, J., Butcher, L.L., and Bredensen, D.E., “A monoclonal Antibody
`that Induces Neuronal Apoptosis Binds to Metastatic Marker”, Cancer Research, 61: 5741-5748, 2001.
`
`5. Srikrishna, G.,Toomre, D., Manzi, A., Paneerselvam, K., Freeze, H.H., Varki, A., and Varki, N., A novel
`anionic modification of N-glycans on mammalian endothelial cells is recognized by activated neutrophils
`and modulates acute inflammatory responses, J. Immunology, 166: 624-632, 2001.
`
`6. Norgard-Sumnicht, K., Bai, X., Esko, J., Varki, A., and Manzi, A.E. Exploring the Outcome of Genetic
`Modifications of Glycosylation in Cultured Cell Lines by Concurrent Isolation of the Major Classes of
`Vertebrate Glycans, Glycobiology, 10: 691-700, 2000.
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`7. Manzi, A. E., Norgard-Sumnicht, K., Argade, S., Marth, J. D., van Halbeek, H. and Varki, A., Exploring
`the Glycan Repertoire of Genetically Modified by Isolation and Profiling of the Major Glycan Classes
`and Nano-NMR Analysis of Glycan Mixtures, Glycobiology, 10: 669-689, 2000.
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`8. Krug, P., and Manzi, A.E., Waterborne and surface-associated carbohydrates as settlement cues for
`larvae of the specialist marine herbivore Alderia modesta, Biological Bulletin, 197: 94-103, 1999.
`
`9. Characterization of mammalian UDP-GalNAc:glucuronide 1-4-N-acetylgalactosaminyltransferase.
`Miura, Y., Ding, Y., Manzi, A.E., Hindsgaul, O., and Freeze, H.H., Glycobiology, 9: 1053-60, 1999.
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`Pharmacosmos A/S v. Luitpold Ex. Pharmaceuticals, Inc., IPR2015-01490
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`Luitpold Pharmaceuticals, Inc., Ex. 2057, P. 9
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`10. Klein A, Diaz S, Ferreira I, Lamblin G, Roussel P and Manzi AE. New sialic acids from biological
`sources identified by a comprehensive and sensitive approach: liquid chromatography-electrospray
`ionization-mass spectrometry (LC-ESI-MS) of Sia quinoxalinones. Glycobiology, 7: 421-432, 1997.
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`11. Mehta DP, Ichikawa M, Salimath PV, Etchison JR, Haak R, Manzi A, and Freeze HH A lysosomal
`cysteine proteinase from Dictiostelium Discoydeum contains N-acetylglucosamine-1-phosphate bound
`to serine, but not mannose-6-phosphate on N-linked oligosaccharides, J. Biol. Chem., 271: 10897-
`10903, 1996.
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`12. Norgard-Sumnicht K, Roux L, Toomre DK, Manzi A, Freeze HH, and Varki A. Unusual anionic N-linked
`oligosaccharides from bovine lung. J.Biol.Chem. 270: 27634-27645, 1995.
`
`13. Manzi AE, Salimath PV, Spiro RC, Keifer PA, and Freeze H. Identification of a novel glycosamino-
`glycan core-like molecule I: 500MHz NMR analysis using a Nano-NMR probe indicates the presence
`of a terminal -GalNAc residue capping 4-methylumbelliferyl--D-xylosides, J. Biol. Chem. 270: 9154-
`9163, 1995.
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`14. Manzi AE, Higa HH, Diaz S, and Varki A. Intramolecular Self-cleavage of Polysialic Acid, J. Biol. Chem.
`269: 23617-23624, 1994.
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`15. Powell LD, Paneerselvam K, Vij R, Diaz S, Manzi A, Buist N, Freeze H, and Varki A. Carbohydrate-
`deficient Glycoprotein Syndrome - Not an N-linked Oligosaccharide Processing defect, but an
`Abnormality in lipid-linked oligosaccharide biosynthesis?, J. Clin.Invest. 94: 1901-1909, 1994.
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`16. Rothenberg B, Hayes BK, Toomre D, Manzi AE, and Varki A. Biotinylated diaminopyridine (BAP): a
`novel approach to tagging oligosaccharides and exploring their biology. Proc. Natl. Acad. Sci. 90:
`11939-11943, 1993.
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`17. Sjoberg E, Manzi AE, Dell A, Khoo K-H, and Varki A. Structural and immunological characterization
`of O-acetyl GD2: evidence that GD2 is an acceptor for ganglioside O-acetyltransferase in human
`melanoma cells. J. Biol. Chem. 267: 16200-16211, 1992.
`
`18. Manzi AE, Sjoberg E, Diaz S and Varki A.: Biosynthesis and turnover of O-acetyl and N-acetyl groups
`in the gangliosides of human melanoma cells. J. Biol. Chem. 265: 13991-13103, 1990.
`
`19. Manzi AE, Diaz SL and Varki A. High pressure liquid chromatography of sialic acids on a pellicular
`resin anion-exchange column with pulsed amperometric detection: a comparison with six other
`systems. Analytical Biochem 188: 20-32, 1990.
`
`20. Manzi AE, and Cerezo AS: Cell wall carbohydrates of the endosperm of the seed ofGleditsia
`triacanthos. Plant Physiology 92: 931-938, 1990.
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`21. Manzi AE, Dell A, Azadi P and Varki A. Studies of naturally occurring modification of sialic acids by
`fast-atom bombardment-mass spectrometry. J. Biol. Chem. 265: 8094-8107, 1990.
`
`22. Higa H, Manzi A and Varki A: O-Acetylation and de-O-acetylation of sialic acids: purification,
`characterization and properties of a glycosylated rat liver esterase specific for 9-0-acetylated sialic
`acids. J. Biol. Chem. 264: 19435-19442, 1989.
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`23. Manzi AE, and Cerezo AS: Substitution reactions of Galactomannans in organic media. Carbohydr.
`Polymers 6: 349-359, 1986.
`24. Manzi AE, Shoolery J and Cerezo AS: High resolution 13C-NMR spectroscopy of legume-seed
`galactomannans. Carbohydr. Res. 148: 189-197, 1985.
`
`25. Manzi AE, and Cerezo AS: Galactomannan-like oligosaccharides from the endosperm of the seed of
`Gleditsia triacanthos. Carbohydr. Res. 134: 115-131, 1984.
`
`26. Manzi A: Chemical Study of the Endosperm of the Leguminous Seed, Gleditsia triacanthos, Univ. of
`Buenos Aires (Thesis to fulfill Ph.D. requirements, Organic Chemistry), December, 1984.
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`27. Manzi AE, Mazzini, MN and Cerezo AS: The galactomannan system from the endosperm of the seed
`of Gleditsia triacanthos. Carbohydr. Res. 125: 127-143, 1984.
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`28. Nudelman, NS and Manzi AE: Preparation of styphnic acid. Rev. Latinoam. de quimica 9: 87, 1978.
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`Pharmacosmos A/S v. Luitpold Ex. Pharmaceuticals, Inc., IPR2015-01490
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`Luitpold Pharmaceuticals, Inc., Ex. 2057, P. 10
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`

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`BOOK CHAPTERS
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`1. Manzi AE., “Carbohydrates and Their Analysis: Sensitive Markers and Tools for Bioprocess
`Monitoring”, Bioprocess International, 2008.
`
`2. Manzi AE., and van Halbeek, H. General Principles for the Analysis and Sequencing of Glycans, IN
`"Essentials of Glycobiology", Varki, A., Cummings R., Esko J., Freeze H., Hart,G and Marth J. (Eds).
`pages 581-598, 1999 Cold Spring Harbor Laboratory Press, New York.
`
`3. Manzi AE., and van Halbeek, H. Glycan Structure and Nomenclature, IN "Essentials of Glycobiology",
`Varki, A., Cummings R., Esko J., Freeze H., Hart,G and Marth J. (Eds), pages 17–29, 1999 Cold Spring
`Harbor Laboratory Press, New York.
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`4. Townsend, RR, Manzi AE., Merkle, R, Rhode, M, Spellman, M., Smith, A, and Carr, S: Monosaccharide
`composition analysis: A Multicenter Study by the ABRF Carbohydrate Committee, IN: ABRF News, Vol.
`8, No. 1, pp 14-21, 1998.
`
`5. Manzi AE and Keifer PA. New Frontiers in NMR Spectroscopy: Use of a Nano•NMR Probe for the
`Analysis of Microgram Quantities of Complex Carbohydrates. IN: Techniques in Glycobiology,
`Townsend, R.R., ed., Marcel Dekker, Inc., New York, pp 1-15, 1997.
`
`6. Manzi AE. HPLC Methods for analysis of negative charge of oligosaccharides, Unit 17.21A, pp 17.21.1-
`17.21.8, 1995, IN Analysis of the Oligosaccharides of Mammalian Glycoconjugates, Current Protocols
`in Molecular Biology, Ausubel et al., Eds., Greene Publishing/Publishing/Wiley Interscience.
`
`7. Manzi AE. Total Compositional Analysis by HPLC or GLC, pp 17.19.14-1.19.25, 1995, IN Analysis of
`the Oligosaccharides of Mammalian Glycoconjugates, Current Protocols in Molecular Biology, Ausubel
`et al., Eds., Greene Publishing/Publishing/Wiley Interscience.
`
`8. Manzi AE. DMB assay of sialic acids by HPLC, Unit 17.18, pp 17.18.14-17.18.19, 1995, IN Analysis of
`the Oligosaccharides of Mammalian Glycoconjugates, Current Protocols in Molecular Biology, Ausubel
`et al., Eds., Gre