We’re excited to announce September’s Formulation Forum, featuring co-speakers Kevin Bittorf, Ph.D., and Keith Parent on September 25th. Kevin and Keith will detail the power of AI in pharmaceutical development, with topics including: 🔹 AI utilization and implementation for drug development 🔹 Data storage, verification, and reliability 🔹 Tools for simplifying complex workflows, improving decision-making, and ensuring regulatory compliance 📅 Register and view the full abstract for September 25th at 2pm EDT: https://lnkd.in/e-w6E9Nx #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopemnt #Formulation #Pharma #Research #Technology #AI #API #CRO #CDMO
Crystal Pharmatech
Pharmaceutical Manufacturing
Cranbury, New Jersey 5,481 followers
A Leading CRO/CDMO for Solid Form & Formulation, Advancing Your PCC to Phase I and Beyond with First-Time-Right Approach
About us
Established in 2010, Crystal Pharmatech is a specialized CRO/CDMO, excelling in crystal form and formulation services. Our exceptional track record includes supporting 1,000 clients and collaborating on over 2,000 compounds, showcasing our expertise in solid-state research, crystallization, pre-formulation, formulation development, and manufacturing. With a global presence encompassing three strategically located R&D centers in New Jersey (USA), Toronto (Canada), and Suzhou (China), we are powered by a skilled team of around 250 professionals. As a leader in both conventional and enabling formulation technologies, including amorphous solid dispersion, we take pride in our cGMP facilities, strictly adhering to the rigorous standards set by the FDA, EMA, and NMPA. Our integrated service encompasses the entire new drug development journey, from developability assessment and solid form screening to pre-formulation, formulation development, and CTM and commercial manufacturing. Introducing our pioneering Mol2Med program, designed to expedite small molecule lead compounds or preclinical candidates into Phase I and beyond, with unparalleled efficiency and precision. This 3-step First-Time-Right approach begins at the lead optimization/PCC stage: Step 1: Developability Assessment to guide API form selection and formulation design. Step 2: Solid form screening/selection and Preformulation. Step 3: Formulation development and CTM manufacturing, including packaging, labeling, and shipping to the clinical site. This innovative approach guarantees a robust API form and a scalable manufacturing process, culminating in a First-Time-Right formulation for Phase I. Streamlining the transition to future clinical studies upon Phase I success, our First-Time-Right approach sets the foundation for optimized drug development and success beyond.
- Website
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http://www.crystalpharmatech.com
External link for Crystal Pharmatech
- Industry
- Pharmaceutical Manufacturing
- Company size
- 201-500 employees
- Headquarters
- Cranbury, New Jersey
- Type
- Privately Held
- Founded
- 2010
- Specialties
- salt screening, polymorph screening, cocrystal screening, API characterization, API process optimization, API crystallization, chiral resolution, preformulation, amorphous solid dispersion, formulation characterization, crystallization development and optimization, Formulation, GMP Manufacturing, Formulation Development, and Clinical and Commercial Manufacturing
Locations
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Primary
3000 Eastpark Blvd
Suite 500B
Cranbury, New Jersey 08512, US
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B4-101
Biobay, Suzhou Industrial Park
Suzhou, Jiangsu 215123, CN
Employees at Crystal Pharmatech
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Peter Langlais
Head, US Business Development
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Xiaoxia (Jessica) Chen
CTO | CMC Leader | Formulator with Pharmacometrics Training | Researcher | Business Development
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Russell Outcalt
Chemistry, Manufacturing and Controls Consultant
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Rositza Petrova, PhD, PMP
Head of US R&D at Crystal Pharmatech
Updates
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Crystal Pharmatech reposted this
How do solubility and permeability influence bioavailability? Tune into this episode of the Formulation Classroom as Senior Scientist, Ritika Joshi, Ph.D., provides answers to this question. This episode outlines: 🔹 Bioavailability 🔹 Solubility 🔹 Permeability Subscribe on YouTube to follow the Formulation Classroom series: https://lnkd.in/eFX-hm67 Crystal Pharmatech #CrystalPharmatech #FormulationClassroom #Formulation #Chemistry #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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💊 Next week, our team of technical formulation experts Xiaoxia (Jessica) Chen and Ridwan Islam, M. Pharm., Ph.D. will be in San Diego. 📅 Schedule some time and stop by Booth 9 to discuss formulation topics. Learn about drug product development and manufacturing capabilities in North America and China. Crystal Formulation Services, a member of Crystal Pharmatech #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopemnt #Formulation #Pharma #Research #Technology #API #CRO #CDMO
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What roles do different types of solid-state screening play in drug development? The Crystal Classroom series begins Section 2 - Screening Protocols with new topics in pharmaceutical science, introduced by Co-Founder Robert Wenslow, Ph.D. This video outlines different types of screening, including: 🔹 Polymorph 🔹 Salt 🔹 Cocrystal The full 23-video Crystal Classroom Characterization section is available on YouTube, in addition to various formulation educational and case study content. Subscribe for further learning: https://lnkd.in/ewuyc_xA #CrystalPharmatech #FormulationClassroom #Formulation #Chemistry #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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Crystal Pharmatech reposted this
Antibody drug conjugate (ADC) related critical quality attributes (CQA) impact safety and efficacy, requiring validation for a specific ADC. This white paper is part 2 of a 3-part series evaluating CQA for relevant modalities. Read more on ADCs in this part of the series, including: 🔹 ADC components 🔹 ADC-related CQA 🔹 Impact on safety and efficacy For more information and further reading, visit: https://lnkd.in/eC3UYNAv #CrystalBio #CrystalPharmatech #PharmaceuticalScience #Biologics #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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Formulation challenges can be addressed by gaining an advanced understanding of your molecule. Join Robert Wenslow, Ph.D. as he continues the CDMO Case Study Series. These videos will dive into various examples where Crystal Pharmatech’s 3-step, first-time-right approach helped ensure a successful formulation for drug innovators. 🔹 Molecule 🔹 Material 🔹 Medicine Subscribe to Crystal Pharmatech on YouTube for more content: https://lnkd.in/eHYFwCwG Crystal Formulation Services, a member of Crystal Pharmatech #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopemnt #Formulation #Pharma #Research #Technology #API #CRO #CDMO
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Crystal Pharmatech reposted this
📅 Join our team in Maryland for the CASSS Mass Spec Symposium from September 10-13. Stop by Booth 7 and tune into our poster session. We are proud to promote the CATUG-Crystal Joint Lab, offering comprehensive nucleic acid services and advanced analytical solutions for the North American market. This partnership, established in 2021, merges Crystal's expertise in CMC, preclinical, and clinical sample analysis for various biologic products with CATUG's tailored methods for release & stability testing, and extended characterization of DNA, RNAs, and diverse LNP formulations. 🔬 Billy Wu Ye Gu Datla Bharat #CrystalBio #CATUGCrystal #CrystalPharmatech #CATUG #PharmaceuticalScience #Biologics #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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Webinar highlight: Case study on air entrapment and how the data from compaction simulation can guide tablet formulation at different production scales. This highlight video expands on a previous highlight that overviewed critical aspects of tablet formulation, including air entrapment. Dr. Feng Li’s Formulation Forum webinar presentation detailed compaction simulation technology and various aspects of tablet formulation. 💡 The full recording is available on-demand to learn more: https://lnkd.in/dK_ffxAm Crystal Formulation Services, a member of Crystal Pharmatech #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Pharma #Research #Technology #API #CRO #CDMO
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📅 Turning the corner into September, we look forward to a great month ahead across the US and in China. #CrystalPharmatech #CrystalBio #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Biologics #Pharma #Research #Technology #API #CRO #CDMO