Ardena’s Post

Did you know that salt screening can significantly impact the success of your drug development journey? 🤔 Our proven 5-step approach identifies the optimal salt version to overcome physicochemical challenges and enhance critical quality attributes like solubility, stability and bioavailability.⬆️ At Onyx, our expertise in salt formation studies allows us to: ✅ Tackle poor drug solubility and dissolution ✅ Improve drug stability and shelf-life ✅ Optimise formulation and manufacturing processes Follow the link to learn more about our salt screening strategy 👉 https://loom.ly/1aK7bm0 #SaltScreening #DrugDevelopment #CDMO #SolidStateChemistry

Watch Erica Schlesinger's on-demand talk from the 2024 Global Drug Bioavailability Enhancement/Controlled & Modified Drug Release Summit to explore a comprehensive approach to technology selection for enhanced formulations. Discover strategies for developing scalable and commercially viable formulations from Phase I onwards. Don't miss out on valuable insights into formulation development that considers drug product design right from the start. Click the link to access the presentation and learn more. https://hubs.li/Q02H0qtB0 Key Takeaways: - Strategic drug product design for a flexible Target Product Profile (TPP) to create an advanceable dosage form for First-in-Human (FIH) studies 🧓👶 - Importance of considering TPP/Product Design in amorphous solid dispersion (ASD) screening 🔬💊 - Impact of particle properties (SDD vs HME) on product design and performance🏭 #drugdevelopment #drugproduct #drugmanufacturing

"Excited to have attended a workshop on Advancing Analytical Techniques of HPTLC-MS! The session provided valuable insights into cutting-edge methodologies, applications, and the potential of combining high-performance thin-layer chromatography with mass spectrometry. Looking forward to applying these techniques in future research and formulation developments. #AnalyticalTechniques #HPTLCMS #Pharmacy #ResearchInnovation #Massspectroscopy

🌟 One Platform, Two Solutions! 🌟 🔍 Predict: Develop and predict purification methods in-silico! 🧪 Powered by GMP compliant software and a comprehensive digital toolkit, the CPC Simulator empowers you to predict and evaluate the most effective purification methods for your compounds of interest (CoI). With access to a vast digital library of 16,000 data entries, including scientific publications, solvent systems, and compound data, achieving your method-development goals has never been easier. 📊💡 🔬 Validate: Take your digital setup from theory to reality with our semi-preparative centrifugal partition chromatographic (CPC) equipment! 🛠️ Test, fine-tune, and optimize your purification method using our benchtop CPC system, ensuring peak performance every step of the way. Witness the transformation of in-silico purification methods into real-life results as you deliver purified materials through the chromatographic process. 🌱💼 Ready to revolutionize your purification workflows? Connect with us today and discover how our platform can streamline your research and development process! 🚀✨ Click the link below to learn more: https://lnkd.in/dqU6YhPm #chromatography #laboratory #pharma #downstreamprocessing #purification #continuousmanufacturing #liquidchromatography #continuousbioprocessing #bioprocessing #pharmaceutical #pharmaceuticalindustry #manufacturing #downstreamprocessing #GMP #biopharma #biotech #biotechnology #cannabisresearch #medicalcannabis #MethodDevelopment #LabInnovation #RealLifeResults

New drugs and chemical entities being developed in recent years have pushed the envelope in helping define new approaches to drug the #undruggable. Many #NCE’s such as #PROTAC drugs have low solubility and utilize alternative #formulation strategies to enhance solubility and help drugs reach exposure levels in the clinic. One strategy is the utilization of Amorphous Solid Dispersions (ASD. While ASD’s have been successful at increasing solubility of drugs, it is critical to ensure sustained stability over the entire shelf life of a drug.   In ASD formulations, extra care must be taken to mitigate stability risks such as separation and recrystallization. This encompasses: 🔹 Drug-polymer compatibility 🔹 Selection of preparation processes 🔹 Storage conditions   Crystal Pharmatech and Crystal Formulation Services (CFS) experts have outlined various stability considerations in the newest edition of the ASD White Paper Series. If you are interested to learn more about how an Amorphous Solid Dispersion could affect the Developability of your #smallmolecule, let’s discuss together.

Continuous manufacturing and a quality-by-design development approach are a natural fit, full article here: https://lnkd.in/eW9V5Mjk To date, approved products that are manufactured using continuous processes leverage hybrid approaches in which one or two unit operations have been implemented in a continuous fashion. The ultimate goal will be to achieve fully integrated continuous manufacturing solutions in which, for small molecules, raw materials undergo conversion via flow chemistry into APIs that are then directly purified (e.g., continuous crystallization) in a continuous fashion, with the purified material then directly fed into a continuous drug-product production process, possibly involving blending with excipients, traditional extrusion, tableting, and coating, as well as hot-melt extrusion, spray-drying, and electrospinning for the formation of amorphous solid dispersions (3). Such an end-to-end (E2E) or fully integrated continuous manufacturing process would provide even more benefits that have been observed with the continuous processes approved to date (3,7). The Novartis-MIT Center for Continuous Manufacturing (CCM) demonstrated the first end-to-end continuous process for production of aliskiren hemifumarate starting from advanced synthetic intermediates through tableting in 2012 (16). Compared to the traditional process, this solution took approximately one-sixth the time. A much smaller version of the reconfigurable flow chemistry unit was then developed and used to produce diphenhydramine hydrochloride, lidocaine hydrochloride, diazepam, and fluoxetine hydrochloride, which were purified in batch mode to generate liquid dosage forms (17,18). The success of this academic-commercial relationship recently spurred follow-on activity by this involving exploration of continuous manufacturing for mRNA products (19), which is heavily encouraged by Peter Marks at FDA. thanks to Cynthia Challener and Pharmaceutical Technology #pharmamanufacturing #pharmaceuticals #qbd #api #excipients #processdevelopment #processimprovement #processoptimization

Biopharmaceutical manufacturers place a very high level of importance on the proper management of raw materials. In order to ensure optimal production efficiency, product efficacy, and the safety of production staff, these materials must be handled with great care. Any potential for contamination must also be avoided wherever possible. For Materials Managers, Process Engineers, and other key personnel, this starts with using the highest quality containers. Whether operating at an R&D, pilot, or commercial scale, single use PETG bottles are amongst the most reliable container types used. Purillex® PETG Square Media Bottles are designed to be seamlessly transitioned into your manufacturing process. They are available in four sizes ranging from 125-1000 mL, both sterile and non-sterile, and are tray-packed, shrink-wrapped, and double-bagged for ease of preparation and filling. Purillex PETG Square Media Bottles exhibit excellent performance even after multiple freeze/thaw cycles as low as -85°C. Click here to download the associated technical note and learn more: https://bit.ly/3ZvoKFS #biopharma #mediabottles #petg #purillex #savillex

"Ensure Pure Water for Your Laboratory! Introducing Our Laboratory Water Deionizer Key Features: - Removes impurities and minerals - Produces high-purity water (18.2 MΩ) - Compact design - Easy operation and maintenance - Compatible with various laboratory equipment Benefits: - Accurate test results - Reduced contamination risk - Increased equipment lifespan - Cost-effective - Enhances laboratory efficiency Ideal for: - Laboratories - Research institutions - Hospitals - Pharmaceutical companies #ChemmartUgandaLtd #LaboratoryWaterDeionizer #WaterPurification #LabEquipment Ensure pure water for your laboratory with our deionizer! Hashtags - #LaboratoryWaterDeionizer - #WaterPurification - #LabEquipment - #ChemmartUgandaLtd - #Healthcare

Can you believe that a #QBD (Quality by Design) approach to product characterisation can identify savings, and reduce production costs by up to 𝟲𝟬%? As part of our CDMO services Biopharma Group champions this approach - significantly reducing the number of developmental cycles needed for formulation and lyophilisation process optimisation. Learn more: https://bit.ly/3RMLRGg #QualitybyDesign #trialanderror #CDMO #services #solutions #lyophilisation #productioncosts

Are you tired of the slow and resource-intensive process of solvent selection in API R&D? 😫 🔍 Discover how SoluDEM can screen 11,000 solvents in just hours and boost your yield improvement! 🚀 🎥 Watch the video to see how you can transform your process and accelerate drug development.💡 👉 Book a Demo here: https://lnkd.in/e3CiZxYY #APIDevelopment #DrugDevelopment #SolventScreening #pharmaInnovation #Pharmaindustry #RandD #SoluDEM #impuritycontrol #formulationdevelopment #pharmademsolutions #pharmatechnology