💡 Webinar Highlight: Understanding funnel flow and hopper geometry to predict powder segregation. It was a pleasure to be joined by Prajwal Thool in yesterday’s Formulation Forum webinar as he shared his expertise in applying predictive and PAT tools to assess powder segregation. 🔎 View the full recording at: https://lnkd.in/diCjGtje 📅 Register for our next webinar on January 22nd at 2pm EST: https://lnkd.in/dV2_Px49 #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Pharma #Research #Technology #AI #API #CRO #CDMO
Crystal Pharmatech
Pharmaceutical Manufacturing
Cranbury, New Jersey 5,627 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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📅 Last chance to register and join us today at 2pm EST for this month’s Formulation Forum! We’re looking forward to learning about innovative approaches to improve powder blend uniformity and control segregation in direct compression blends.
📢 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗳𝗼𝗿 𝗡𝗼𝘃𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝘁𝗵 𝗪𝗲𝗯𝗶𝗻𝗮𝗿 This month’s Formulation Forum webinar will feature Prajwal Thool from Genentech as he presents “Assessment of Powder Segregation in Direct Compression (DC) Blends: Developing Predictive and PAT Tools”. This discussion will provide insights into innovative approaches to improve powder blend uniformity and control segregation in direct compression tablet manufacturing. Topics include: 🔹 Assessing powder segregation risk in direct compression 🔹 Application of Process Analytical Technology (PAT) tools, including Near-Infrared Spectroscopy (NIRS) 🔹 Comparison of Traditional and Novel Techniques for Predicting Segregation 📅 Register and view the full abstract for November 20th at 2pm EST: https://lnkd.in/eMv8pkh8 #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopemnt #Formulation #Pharma #Research #Technology #AI #API #CRO #CDMO
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Crystal Pharmatech reposted this
What stability factors are important to consider for drug product development? Senior Scientist, Ritika Joshi, Ph.D., reviews stability-related topics, including: 🔹 Considerations for most stable API form 🔹 Factors affecting stability Subscribe on YouTube to follow the Formulation Classroom series: https://lnkd.in/ewdApYQX Crystal Pharmatech #CrystalPharmatech #FormulationClassroom #Formulation #Chemistry #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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📢 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗳𝗼𝗿 𝗡𝗼𝘃𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝘁𝗵 𝟮𝗽𝗺 𝗘𝗦𝗧 𝗪𝗲𝗯𝗶𝗻𝗮𝗿 https://lnkd.in/eRs_2mr8 We are excited to be joined by Prajwal Thool from Genentech in this month’s Formulation Forum. Prajwal brings significant experience in the application of alternate techniques to assess powder segregation risk in direct compression blends. His presentation will detail: 🔹 Assessing powder segregation risk in direct compression 🔹 Application of Process Analytical Technology (PAT) tools, including Near-Infrared Spectroscopy (NIRS) 🔹 Comparison of Traditional and Novel Techniques for Predicting Segregation 📅 Register and view the full abstract for November 20th at 2pm EST: https://lnkd.in/eRs_2mr8 #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Pharma #Research #Technology #AI #API #CRO #CDMO
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How do scientists select the best polymorph to develop? Senior Scientist, Daniel Walters, PhD, details the key considerations for polymorph selection, including: 🔹 Solubility 🔹 Phase Origin (anhydrate, hydrate, solvate and solvent classification) 🔹 Stability Subscribe on YouTube to keep up with the series: https://lnkd.in/eqt-b3cx #CrystalPharmatech #CrystalClassroom #Chemistry #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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📢 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗳𝗼𝗿 𝗡𝗼𝘃𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝘁𝗵 𝟮𝗽𝗺 𝗘𝗦𝗧 𝗪𝗲𝗯𝗶𝗻𝗮𝗿 https://lnkd.in/emPK635b The direct compression process is highly desirable for producing solid oral dosage forms due to its simplicity, efficiency, and small manufacturing footprint. However, it is also highly prone to powder segregation. This webinar will detail the application of alternate techniques to assess powder segregation risk in Direct Compression (DC) blends. In this month’s Formulation Forum, we are joined by Prajwal Thool from Genentech as he details: 🔹 Assessing powder segregation risk in direct compression 🔹 Application of Process Analytical Technology (PAT) tools, including Near-Infrared Spectroscopy (NIRS) 🔹 Comparison of Traditional and Novel Techniques for Predicting Segregation 📅 Register and view the full abstract for November 20th at 2pm EST: https://lnkd.in/emPK635b #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Pharma #Research #Technology #AI #API #CRO #CDMO
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Crystal Pharmatech reposted this
📢 Join Us for an Insightful Webinar on mRNA 5’ Cap Analysis! 📢 🗓 Date: November 14, 2024 🕑 Time: 2:00 - 2:45 PM (EST) We are excited to announce Crystal Bio, a member of Crystal Pharmatech's first webinar featuring Weicheng (Michael) Zhang, Ph.D., Principal Scientist in Analytical Development at CATUG Biotechnology. The 5' cap is crucial for mRNA stability, translation efficiency, and immunogenicity, making its accurate profiling essential for quality control and process optimization. In this session, Dr. Zhang will dive deep into advanced analytical techniques, particularly LC-MS and HPLC, to assess the mRNA 5' cap. Key topics include: 🔹 Measuring capping efficiency 🔹 Differentiating cap structures like Cap 0, Cap 1, and G Cap 🔹 Insights on sample preparation and data interpretation 🔹 Strategies for optimizing methods in mRNA cap analysis Don’t miss this opportunity to learn from an expert in the field! 👉 Register now to gain insights into the latest analytical techniques in mRNA research: https://lnkd.in/edeu5qtQ #CrystalBio #mRNA #5Cap #AnalyticalTechniques #LCMS #HPLC #Biotechnology #Pharmaceuticals #CRO #CrystalPharmatech
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📢 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗳𝗼𝗿 𝗡𝗼𝘃𝗲𝗺𝗯𝗲𝗿 𝟮𝟬𝘁𝗵 𝗪𝗲𝗯𝗶𝗻𝗮𝗿 This month’s Formulation Forum webinar will feature Prajwal Thool from Genentech as he presents “Assessment of Powder Segregation in Direct Compression (DC) Blends: Developing Predictive and PAT Tools”. This discussion will provide insights into innovative approaches to improve powder blend uniformity and control segregation in direct compression tablet manufacturing. Topics include: 🔹 Assessing powder segregation risk in direct compression 🔹 Application of Process Analytical Technology (PAT) tools, including Near-Infrared Spectroscopy (NIRS) 🔹 Comparison of Traditional and Novel Techniques for Predicting Segregation 📅 Register and view the full abstract for November 20th at 2pm EST: https://lnkd.in/eMv8pkh8 #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopemnt #Formulation #Pharma #Research #Technology #AI #API #CRO #CDMO
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Crystal Pharmatech reposted this
What is the Biopharmaceutics Classification System (BCS) and how is it used? Principal Scientist, Sawani Talekar, Ph.D., details BCS Classifications, considering: 🔹 High/Low Solubility 🔹 High/Low Permeability Subscribe on YouTube to follow the Formulation Classroom series: https://lnkd.in/e37PA8As Crystal Pharmatech #CrystalPharmatech #FormulationClassroom #Formulation #Chemistry #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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📅 We’re excited for more opportunities to discuss pharmaceutical science this month. 🔹 Register for the November 20th, 2pm EST webinar: https://lnkd.in/eGZux3YS 🔹 Register for the November 27th Beijing Crystal Form and Formulation Seminar: https://lnkd.in/eaVtm-4T #CrystalPharmatech #CrystalBio #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Biologics #Pharma #Research #Technology #API #CRO #CDMO