The Crystal Pharmatech Formulation Forum continues this month on July 24th with guest speaker Chong-Hui Gu, Ph.D. This presentation will discuss protein degraders to address targets that were previously undruggable. Topics include: 🔹 Factors that limit oral absorption 🔹 Overcoming oral bioavailability challenges 🔹 Alternative routes to deliver protein degraders 📅 Register to attend July 24th at 2pm EDT: https://lnkd.in/eRHNPFyH Please note we cannot share the recording. Live attendance will be the only opportunity to view this presentation. #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopemnt #Formulation #Pharma #Research #Technology #API #CRO #CDMO
Crystal Pharmatech
Pharmaceutical Manufacturing
Cranbury, New Jersey 5,312 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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How can isostructural differences complicate XRPD characterization? Senior Scientist, Daniel Walters, PhD, discusses crystallographic considerations for isostructural phases, including: 🔹 Isostructural molecules vs isostructural phases 🔹 XRPD challenges for isostructural phases 🔹 Causes of diffractogram similarities for isostructural phases Subscribe on YouTube to keep up with the series: https://lnkd.in/ePfym9Xk #CrystalPharmatech #CrystalClassroom #Chemistry #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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What actionable insights can be gained from physiologically based pharmacokinetic (PBPK) modeling? We previously detailed how Simulations Plus, Inc.'s GastroPlus® can be incorporated into a small molecule development program. We now dive into model-informed parameter sensitivity and how those insights can help guide development decisions. Parameters include: 🔹 Food effect 🔹 Solubility 🔹 Particle Size 🔹 Dose PBPK modeling with drug development experts offers a more efficient alternative to trial-and-error PK studies when looking to determine the effects of various parameters on bioavailability. Learn more at: https://lnkd.in/esmFC3Za #CrystalPharmatech #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Pharma #Research #Technology #API #CRO #CDMO
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Crystal Pharmatech reposted this
Assessment of CQA in mRNA-LNP modality is essential to ensure product quality. They can influence: 🔹 Potency 🔹 Stability 🔹 Toxicity 🔹 Risk assessment relevant to mRNA-LNP modality This white paper is the first of a 3-part series written in partnership with CATUG. Stay tuned to learn more about ADC’s and mAb’s later in this series. For more information, visit: https://lnkd.in/eeg42_hj #CrystalBio #CATUGCrystal #CrystalPharmatech #CATUG #PharmaceuticalScience #Biologics #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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Crystal Pharmatech reposted this
We’re excited to be represented by our strategic partner, CATUG, at the CRS 2024 Annual Meeting and Exposition in Italy. Meet with Cesare Di Nitto and Lin Jin to discuss the CATUG-Crystal RNA and LNP capabilities.
We are less than a week away from the CRS 2024 Annual Meeting & Expo! Will we see you there? Please reach out to Cesare Di Nitto or Lin Jin if you are interested in connecting. #CRS2024 #networking #pharma
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Congratulations to these future leaders in science and innovation! Crystal Pharmatech is proud to support the Acton-Boxborough Science Olympiad Team's participation at the Science Olympiad National Tournament in Michigan. These students achieved 5th out of 60 teams, reaching the highest ranking in their high school team's history. Great work!
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In addition to previously covered instruments (PLM, TGA, DSC, XRPD), what other instruments are commonly used for API characterization? Subject Matter Expert, Derik McCarthy, covers additional instruments vital to API characterization such as: 🔹 High-Performance Liquid Chromatography (HPLC) 🔹 Particle Size Distribution Analyzer (PSD) 🔹 Karl Fischer Titration (KF) 🔹 Gas Chromatography (GC) Subscribe on YouTube to keep up with the series: https://lnkd.in/e69284yX #CrystalPharmatech #CrystalClassroom #XRPD #Chemistry #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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It was a pleasure to present and discuss specialized formulation strategies at the 2024 Controlled & Modified Drug Release Summit this week in Princeton. We look forward to future opportunities to engage with drug innovators and advance pharmaceutical science through collaboration. #CrystalPharmatech #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Pharma #Research #Technology #API #CRO #CDMO
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How can a technology-driven CRDMO incorporate physiologically based pharmacokinetic (PBPK) modeling into your small molecule program? Insights from Simulations Plus, Inc.’s GastroPlus® can be utilized by solid-state and formulation experts to optimize: 🔹 Lead candidate selection 🔹 GLP Tox formulation 🔹 FIH formulation An earlier understanding of the ADME profile for drug candidates can help innovators save time, money, and material. Learn more at: https://lnkd.in/eZkRNTUQ #CrystalPharmatech #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Pharma #Research #Technology #API #CRO #CDMO