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Delivering the impact of solid-state properties in pharmaceutical development
Solid-State Research and CMC Service
Cranbury, New JerseySuzhou, China
John [email protected]
610-360-6154
3000 Eastpark Blvd. Suite 500B
Cranbury New Jersey 08512
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Contract Research Organization
• Specializing in solid-state drug research and CMC service, all driven by technology
• Founded by scientists with decades of large pharmaceutical experience
• We apply the right resources just in time, to solve your most critical challenges
• Our experience becomes your competitive advantage, from lead optimization through manufacturing
Over 500 clients worldwide
Supported solid form screening and crystallization of over 1,500 drug molecules
54,000 ft2 research facility located in Suzhou, China
10,000 ft2 research facility located in Cranbury, New Jersey
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• Solid-StateCharacterization
• SolidFormScreeningandSelection
• Polymorph/Salt/Co-CrystalScreening
• OptimalFormRecommendation
• FormStabilityandSolubility
• SingleCrystalStructureDetermination
• FormIdentificationandQuantification
Solid-StateResearch
• CrystallizationProcessDevelopment
• Purification
• ParticleAttributesControl
• PolymorphicIsolation
• ChiralSeparation
• CrystalGreen
Crystallization OrganicSynthesisFormulationDevelopment
• ScaleUpofAPIforearlydevelopment
• ProcessRouteScouting(Research)
• ProcessOptimization(Development)
• APIandIntermediatesImpurityStudy
• APIProcessDocumentationTheintermediateisolationbycrystallizationtoincreaseprocessefficiency(lesssolvent,lesstime,increasedscale).
Services
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• PK and Tox Studies • Solution, Suspension
• Solubility Enhancement
• Amorphous Solid Dispersion • Spray drying
• Nanomilling
• Dissolution test
• Prototype/Probe/IND
Stability Studies
• pKa, LogP(D)
Executive Team
Alex M. Chen Yanfeng Zhang Robert Wenslow
About Us
• 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
• 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
• 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
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Dr. Russell Outcalt Professor Nair Rodriguez-Hornedo Dr. Elizabeth Vadas Professor Lian Yu
R. Outcalt Consulting University of Michigan InSciTech Inc. University of Wisconsin
Scientific Advisory Board
• Co-founder of Scynexis, established the Process and Analytical Chemistry departments, and former Executive Director of CMC, responsible for CMC aspects of SCY-078 anti-fungal and SCY-635 anti-viral
• Developed a research program based on molecular-mechanistic approaches founded on the concepts of supramolecular chemistry and crystal engineering
• Serves on the FDA Advisory Committee for Pharmaceutical Sciences and on the editorial boards of Crystal Growth and Design, Molecular Pharmaceutics and Journal of Pharmaceutical Sciences
• 22 years experience at Merck Frosst, former head of Department of Pharmaceutical Research and Development (early compound characterization to formulation & process development of NCE, including the supply of clinical trial materials). Key contributor on formulation development of SINGULAR® and several other products that lead to worldwide regulatory approval
• Past president of CSPS, elected Fellow of AAPS and CSPS, adjunct professor of pharmaceutics at the University of Montreal
• •Leading researcher on solid-state chemistry (polymorphism, crystallization of organic glasses, and molecular motions in solids)
• Honors - 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 AAPS
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Our Partnership Advantages
Our experience becomes your competitive advantage…
Project Management Flexibility Speed Efficiency Minimal Red Tape
Experience Scientific Business Development Experienced Executive Team World Renowned SAB
Two locations (US and China) 10,000 sq ft. in New Jersey; 54,000 sq ft. in Suzhou, China Convenience and Flexibility Cost advantages
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Fee for Service Crystal Blanket (Open PO) FASTFTE
We make it easy…
• Saves time and money
• Covers all of our services
• Free consultation anytime
• Pricing and timing agreed upon in advance
• Single point of contact (project manager)
• Simple work summary tracking
• Report timing at your discretion
• Pay only for completed services
•
Focused Analytical Solids Testing
Service
• Submit sample for analysis (XRPD, DSC, TGA, DVS, PSD, etc.)
• Results delivered in 2 business days
• Pay after getting report
Pay as you Go Our proposals: • 24-48hr turnaround
• Drafted by experienced scientists
• Transparent pricing
• Upfront pricing
• No hidden fees
• Our discoveries drive the projects
•
Risk Free, single Blanket PO covering all of our CMC services
• Makes your life easier
• Single point of contact (project manager)
• Agreed upon, up-front pricing, material requirements and timelines
• Pay only for work completed
• Simple work-summary tracking files
• Updates on agreed upon frequency
• Invoice quarterly or as desired
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We provide: • Shipping box with Pre-paid shipping label • Reports • Raw data
You Provide : • Compound (50mg)
• Executed NDA (Send us yours)Email John to receive your free kit:
You qualify if: Your company is new to Crystal Pharmatech andYour compound is:
• a small molecule• is at least 95% pure • is not highly toxic or potent
Free kit provides:• One FREE baseline form characterization (XRPD, DSC, TGA, & PLM) • Gap Analysis • Risk Assessment • Path forward discussion
Our Free Solid Form Evaluation
Benefits of FREE Solid-State Analysis: • Consistent PK studies • Understanding API process liabilities • Correlation of stability concerns • A substantial impact on your development process
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3000 Eastpark Boulevard, Suite 500 B Cranbury, NJ 08512 USA [email protected] 610-360-6154
B4-101, Biobay, 218 Xinghu Street, Suzhou Industrial Park Suzhou, China, 215123 [email protected] 86-512-69561921 or 69561923
Crystal Pharmatech (USA)
Crystal Pharmatech (China)
Contact Us
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