YOUR Reliable Partner for Drug Solid-state Research and CMC Service
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1 YOUR Reliable Partner for Drug Solid-state Research and CMC Service (US) (China)
2 Company Overview 1 A technology-driven organization specialized in ONE-STOP SHOP utilizing solid-state and biopharmaceutical properties in design from candidate selection through early development 54,000 ft 2 research facility located in both US and China Over 300 clients worldwide OPTIMIZED ROUTE to achieve exposure, eliminate unnecessary experiments and enable pre-clinical studies INTEGRATED APPROACH to find the right form and formulation Supported solid form screening and crystallization of over 1,000 drug molecules
3 Core Services 2 Drug Solid-State Research Process R&D Formulation Development Analytical Research Solid Form Screening and Selection Polymorph/Salt/Co-Crystal Screening Thermodynamic Phase Relationship Stability and Solubility Evaluation Optimal Form Recommendation Single Crystal Growth and Structure Determination Solid-State Characterization Form Identification and Quantification Process Route Scouting (Research) Process Optimization (Development) Pilot Plant (Manufacture) Technical Support API and Intermediates Impurity Study API Process Documentation Crystalization Development Purification Particle Attributes Control Polymorphic Isolation Solubility Measurement and Enhancement Physicochemical Characterization Formulation Development for PK and Tox Study (solution, suspension) Formulation Development for Early Stage Clinical Trials (tablet, capsule, IV) Method Development and Validation Physicochemical Property Determination (pka, LogP, LogD, solubility) Prototype/Probe/IND Stability Studies Dissolution Test Release Testing Chiral Separation
4 Executive Team 3 Alex M. Chen, PhD Co-founder, CEO PhD in Chemistry, Rutgers University >8 yrs at Merck in R&D and manufacturing >Supported physical characterization, API phase selection and evaluation of more than 50 compounds in all stages of development >Expert on solid-state characterization, polymorphism, co-crystal screening, chiral resolution, and nanoparticle engineering Yanfeng Zhang, PhD Co-founder, CSO PhD in Chemical Engineering, Princeton University >5 yrs at Merck supporting more than 80 development projects in close collaboration with scientists in multiple disciplines >Expertise in solid-state research, salt/polymorph screen and selection, amorphous solid dispersion, thermodynamics and kinetics modeling Robert Wenslow, PhD VP B.D. US & EU PhD in Chemistry, Pennsylvania State University >14 yrs at Merck in drug R&D, manufacturing and management >Expertise in solid-state NMR, maintaining direct responsibilities of solid-state NMR facility at Merck >Established first analytical research group in Ireland for Merck Ann Newman, PhD VP Sci. Dev., Head of Sci. Adv. Board PhD in Chemistry, Connecticut University >10 yrs at BMS in materials science & characterization of APIs and drug products >10 yrs at SSCI in solid form screening/selection, characterization and problem solving for large and small pharmaceutical companies >Expertise in solid-state pharmaceutics, polymorphs, salts, co-crystals, amorphous, amorphous dispersions and screening
5 Executive Team 4 Fengrui Lang, PhD VP Process Chemistry PhD in Organic chemistry, Boston College >7 yrs at Merck in Process R&D, 12 yrs at Chinese pharmaceuticals >Expertise in design and development of novel process to produce APIs from lab-scale to plant scale for clinical development. >Established and managed R&D team in China Gregory A. Stephenson, PhD Senior Scientific Advisor PhD in Medicinal Chemistry, Purdue University >27 years at Eli Lilly and Company in pharmaceutical development focused on pre-clinical and clinical formulation development >Cross-functional project management experience in complex work environment >Experienced in patenting of crystal forms and formulations and in litigation Shanming Kuang, PhD VP R&D US PhD in the Chinese University of Hong Kong. Postdoc Purdue University >12 years at BMS, Roche, and GSK. >His tenure involved managing solid state chemistry groups involved in integrated drug development teams focusing on form and formulation selection >His teams were integral in understanding compound developability and ensuring projects were minimally impacted by solid state property issues. Carlos Sanrame, PhD Director of BD PhD in Physical Organic Chemistry UNC (Argentina) Postdoc UCLA, Ottawa U. > 12 years of experience as a pharmaceutical research scientist at Alkermes plc and Transform/Johnson & Johnson focused on pre-clinical and clinical formulation development and solid state. >Author/coauthor of 20+ peerreviewed articles and patents, and of 40+ scientific presentations.
6 Scientific Advisory Board 5 Prof. Joel Bernstein New York University Dr. Russell Outcalt R. Outcalt Consulting, LLC Prof. Naír Rodríguez-Hornedo University of Michigan Dr. Elizabeth Vadas InSciTech Inc. Prof. Lian Yu University of Wisconsin Organic Solid-state CMC Co-crystal Formulation Solid-state Chemistry > Research includes organic solid state, with particular emphasis on understanding and utilizing polymorphism, structure-property relationships etc. > Punctuated by visiting professorships at the University of Illinois, Cornell University, the University of Minnesota, etc. and as a visiting scientist at the Cambridge (UK) Crystallographic Data Centre > Awards include Fellow of the American Association for the Advancement of Science (1999) > The sole author of a book entitled Polymorphism in Molecular Crystals, published by Oxford University Press > 35 years experience in Discovery and Process Chemistry in the pharmaceutical and life sciences industries with Union Carbide, Rhone-Poulenc and Scynexis, Inc. > Co-founder of Scynexis, Inc., establishing the Process and Analytical Chemistry departments, and former Executive Director of Chemistry, Manufacturing and Controls, responsible for CMC aspects of SCY-078 anti-fungal and SCY-635 anti-viral > Key contributions to development of Fipronil (Frontline ) parasiticide and Isoxaflutole (Balance ) herbicide > Developed a research program based on molecularmechanistic approaches, founded on the premise that the concepts of supramolecular chemistry and crystal engineering > Serve on the FDA Advisory Committee for Pharmaceutical Sciences > Serve on the editorial boards of Crystal Growth and Design, Molecular Pharmaceutics and Journal of Pharmaceutical Sciences > Awards include Ebert Prize for the best article published in the Journal of Pharmaceutical Sciences in 2005 > 22-year experience at Merck Frosst, former head of Department of Pharmaceutical Research and Development, responsible from early compound characterization to formulation and process development of new chemical entities including the supply of clinical trial materials from phase I through phase III and technical transfer to manufacturing > Key contributor on formulation development of SINGULAIR and several other products that lead to worldwide regulatory approval > Past president of CSPS, elected Fellow of AAPS and Fellow of CSPS, adjunct professor of pharmaceutics at the University of Montreal > Leading researcher on solidstate chemistry > Research areas focused on polymorphism, crystallization of organic glasses, and molecular motions in solids. > Honors include Elected Fellow of AAPS, Lilly Research Laboratories President's Award, and Invited Visiting Professorship at the University of Manchester, and David Grant Research Achievement Award in Physical Pharmacy from American Association of Pharmaceutical Scientists
7 Solid-State Research Instruments 6 Panalytical Empyrean /Bruker D8 XRPD Bruker 500 MHz WB SSNMR DSC-Q200, Q2000 TGA-Q500, Q5000 DVS Intrinsic DXR Raman Microscope Microtrac S-3500 PSD Analyzer CM Protégé PharmD System Zeiss Polarized Light Microscope
8 Process Instruments 7 EasyMax Crystal 16 OptiMax FBRM G400 ReactIR 45m
9 Analytical Research Instruments 8 Agilent HPLC 1260, 1100 Agilent 7820A GC Dionex ICS-1000 Ion Chromatograph Dissolution (Agilent 708-DS/Sotax AT7 Smart ) Metrohm 848 Titrino Plus Metrohm 870 Karl Fisher Titrator Water Activity Meter (Aqualab Series 4 TE) Sirius T3 pka Memmert HCP246 Stability Chamber
10 Data Quality / IP 9 Enforced data check and review system to ensure all data set are complete, accurate, reliable and timely provided to the clients Validity Completeness Accuracy Timeliness Consistency Integrity Data Quality & Intellectual Protection is of our utmost importance to client satisfaction and sustainable growth. Data Verification System We are dedicated to high quality service and trustworthy relationship with every clients regardless of project or client size. IP Information Privacy System Information Security Training Confidential Disclosure Agreements Novel Sample Numbering System Monitoring Cameras System Data Encryption System
11 New NJ expansion 10 Our New Address 3000 Eastpark Boulevard, Cranbury, NJ USA
12 Contact Us 11 Crystal Pharmatech Inc. (USA) 3000 Eastpark Boulevard, Cranbury, NJ USA Phone: Crystal Pharmatech Co., Ltd. (China) B4-101, Biobay, 218 Xinghu Street, Suzhou Industrial Park Suzhou, China, Phone: or
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