Thank you to Chong-Hui Gu, Ph.D. and everyone that joined us for this month’s episode of the Crystal Pharmatech Formulation Forum. Dr. Gu gave a fascinating presentation on protein degraders and ensuring their bioavailability. While the recording is not available to share, please enjoy this highlight from the Q&A session with Robert Wenslow, Ph.D. We will be posting more clips to come from this engaging presentation – stay tuned! 📅 Don’t miss our next webinar on August 21 at 2pm EDT. Register today at: https://lnkd.in/dvucNQCv #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Pharma #Research #Technology #API #CRO #CDMO
Crystal Pharmatech
Pharmaceutical Manufacturing
Cranbury, New Jersey 5,368 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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📅 Don't forget to register and join us at 2pm EDT today. The insights from Dr. Gu will only be available during the live presentation. See you there!
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
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Crystal Pharmatech reposted this
What factors affect permeability for drug compounds? Senior Scientist, Sawani Talekar, Ph.D., hosts another episode of the Formulation Classroom to explore various factors including: 🔹 Chemical composition 🔹 Solubility 🔹 Particle size 🔹 Efflux transporters Subscribe on YouTube to follow the Formulation Classroom series: https://lnkd.in/emmzFnkE #CrystalPharmatech #FormulationClassroom #Formulation #Chemistry #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Research #Technology #API #CRO #CDMO
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Gain insights from experts across the industry. This month on the Formulation Forum, we are proud to host Chong-Hui Gu, Ph.D. from Foghorn Therapeutics. Dr. Gu is responsible for CMC, supply chain, and quality assurance at Foghorn Therapeutics. His experience includes: 🔹 20 years in drug discovery and development 🔹 CMC and formulation for numerous commercial drugs, including IDHIFA®, TIBSOVO®, INCIVEK®, KALYDECO®, ORKAMBI®, and ELIQUIS® 🔹 Previous positions with Agios Pharmaceuticals, Vertex Pharmaceuticals, and Bristol-Myers Squibb Join us this Wednesday (7/24) at 2pm EDT as Dr. Gu presents “Overcoming Bioavailability Barrier to Deliver Protein Degraders” on this month’s Formulation Forum. 📅 Register to attend: https://lnkd.in/eWhC4VMm Please note, we cannot share the recording. Live attendance will be the only opportunity to view this presentation. #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Pharma #Research #Technology #API #CRO #CDMO
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💡 Expertise from across the industry: Join us on July 24th for the next webinar in the Formulation Forum series. In this month’s webinar, we will be joined by Chong-Hui Gu, Ph.D. to discuss protein degraders with topics including: 🔹 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/eSiDEqwi Please note, we cannot share the recording. Live attendance will be the only opportunity to view this presentation. #CrystalPharmatech #FormulationForum #PharmaceuticalScience #CMC #Biotech #DrugDevelopment #Formulation #Pharma #Research #Technology #API #CRO #CDMO
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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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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
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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