Compaction simulation is an advanced technology that helps in understanding how a powder blend will behave under compression, which is crucial for developing robust and effective tablet formulations. In this month’s Formulation Forum, we are joined by Feng Li, Ph.D. as he details compaction simulation with topics including: 🔹 Important aspects of pharmaceutical tablet compression 🔹 Compaction simulation technology 🔹 How and why compaction simulation works 🔹 Compaction simulator case studies 📅 Register to attend August 21 at 2pm EDT: https://lnkd.in/dtRVZUFV #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Pharma #Research #Technology #API #CRO #CDMO
Crystal Pharmatech
Pharmaceutical Manufacturing
Cranbury, New Jersey 5,418 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
📅 Meet our Boston-based team at the 16th Annual Bioprocessing Summit from August 19-22. Stop by Booth T13 and tune into the presentation by Ye Gu, Ph.D. 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. 🔬 Ridwan Islam, M. Pharm., Ph.D. Billy Wu #CrystalBio #CATUGCrystal #CrystalPharmatech #CATUG #PharmaceuticalScience #Biologics #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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💡 Another highlight from the Formulation Forum Chong-Hui Gu, Ph.D. and Robert Wenslow, Ph.D. discuss monitoring the stability of injectables. 📅 Register for the next webinar on August 21 at 2pm EDT: https://lnkd.in/dpE7piUB Feng Li, Ph.D. will detail compaction simulation technology and its utility for advancing oral dosage formulation design. #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Pharma #Research #Technology #API #CRO #CDMO
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Overcoming formulation challenges through an advanced understanding of your molecule. Join Robert Wenslow, Ph.D. as he outlines the first compound of this 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/eaCd5t6P 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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Solid-state characterization is vital for ensuring product quality, consistency, and stability throughout the drug development lifecycle. Join Subject Matter Expert, Maili Heshuote, as she looks back on characterization principles discussed in this series and looks ahead to our upcoming screening topics. So far, Crystal Classroom has discussed: 🔹 𝗣𝗮𝗿𝘁 𝟭: Polarized light microscopy (PLM) 🔹 𝗣𝗮𝗿𝘁 𝟮: Thermogravimetric analysis (TGA) 🔹 𝗣𝗮𝗿𝘁 𝟯: Differential scanning calorimetry (DSC) 🔹 𝗣𝗮𝗿𝘁 𝟰: X-ray powder diffraction (XRPD) 🔹 𝗣𝗮𝗿𝘁 𝟱: Advanced characterization In the next phase of the Crystal Classroom, our experts will explain a variety of screening protocols. Subscribe and view the full series on YouTube at: https://lnkd.in/ecqtfxaF #CrystalPharmatech #CrystalClassroom #Chemistry #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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Crystal Pharmatech reposted this
Polymer selection is a critical aspect of ensuring the success of a hot melt extrusion (HME) formulation. This white paper outlines the various criteria for HME polymer selection, including: 🔹 Criteria for polymers in HMEs 🔹 PVP polymers 🔹 Cellulose derivative polymers 🔹 Other polymers 🔹 Application of HPMCAS in HME Read more and keep up with the ASD series at: https://lnkd.in/eRZDEJ34 Crystal Pharmatech #CrystalPharmatech #CFS #ASD #HME #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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In this month’s Formulation Forum, we welcome guest speaker Feng Li, Ph.D. on August 21st. This presentation will detail compaction simulation topics including: 🔹 Powder compaction principles 🔹 The application of compression simulation technology 🔹 Formulation process design 🔹 Process scale-up 🔹 Troubleshooting compaction challenges Register to attend August 21 at 2pm EDT: https://lnkd.in/eCJh8P8V #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopemnt #Formulation #Pharma #Research #Technology #API #CRO #CDMO
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Crystal Pharmatech reposted this
Join the Crystal Bio team in Philadelphia this week at the Immuno-Oncology Summit. The poster session presented by Ye Gu, Ph.D. will highlight expertise in mRNA and LNP capabilities at the CATUG-Crystal joint lab with our strategic partner, CATUG. Datla Bharat Chitrangada Acharya #CrystalBio #CATUGCrystal #CrystalPharmatech #CATUG #PharmaceuticalScience #Biologics #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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Crystal Pharmatech reposted this
A robust analytic technique for D0 characterization and release testing is vital for ensuring the safety and efficacy of antibody drug conjugates (ADCs). This white paper overviews 🔹 What is D0 in ADC? 🔹 The relevance of D0 🔹 D0 impact on ADC potency 🔹 Differentiating D0 in ADC 🔹 How to characterize DAR in ADCs For more information, visit: https://lnkd.in/eE6cv6Wt #CrystalBio #CrystalPharmatech #PharmaceuticalScience #Biologics #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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📅 An exciting month ahead - Join us this August as we discuss pharmaceutical innovation online, across the US, and in China. CATUG #CrystalPharmatech #CATUG #CATUGCrystal #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Biologics #Pharma #Research #Technology #API #CRO #CDMO