APURUN’s Post

What are the key factors to consider during the technology transfer of LNP manufacturing processes? The technology transfer of lipid nanoparticle (LNP) manufacturing processes is a complex endeavor that requires careful consideration of several key factors to ensure a smooth and successful transition. One of the most critical factors is the thorough documentation of the entire manufacturing process, including all standard operating procedures (SOPs), process parameters, and quality control measures. Detailed documentation ensures that the receiving site has all the necessary information to replicate the process accurately and consistently, minimizing the risk of deviations that could affect product quality. Another important factor is the training of personnel at the receiving site. It is essential to provide comprehensive training to the team that will be responsible for manufacturing the LNPs, including hands-on training with the equipment and a deep understanding of the critical process parameters. This training should cover all aspects of the production process, from raw material handling to final product testing, to ensure that the receiving site can produce LNPs that meet the same quality standards as the original site. In some cases, it may be beneficial to involve the transferring site’s personnel in the initial production runs at the receiving site to provide direct support and oversight. Process validation is also a key consideration during technology transfer. The manufacturing process must be validated at the receiving site to confirm that it can consistently produce LNPs that meet the predefined specifications for particle size, encapsulation efficiency, and stability. This validation process may involve conducting pilot-scale production runs and comparing the quality attributes of the LNPs produced at the receiving site with those produced at the original site. By carefully addressing these factors, companies can ensure a successful technology transfer that maintains the integrity and quality of the LNP manufacturing process. #LipidNanoparticles #TechnologyTransfer #PharmaceuticalManufacturing #ProcessDocumentation #StandardOperatingProcedures #SOPs #QualityControl #PersonnelTraining #PharmaTraining #ProcessValidation #Nanomedicine #DrugDelivery #NanoparticleManufacturing #ManufacturingExcellence #GMPCompliance #PharmaTechnology #ProcessOptimization #BatchConsistency #PilotProduction #LNPStability #EncapsulationEfficiency #ParticleSizeControl #PharmaceuticalQuality #Nanotechnology #PharmaInnovation #TechTransferSuccess #PharmaceuticalDevelopment #ProcessStandardization #PharmaR&D #NanoparticleFormulation https://lnkd.in/gA2MvYPb

Creating sterile packaging system: design, biocompatibilities properties, toxicological properties....

This article provides an insightful overview of the significance of viscosity measurements in the manufacturing industry, highlighting GAO Tek’s range of viscometers and their diverse applications. The manufacturing sector, comprising various industries like automotive, pharmaceuticals, and electronics, heavily relies on accurate viscosity measurements for ensuring product quality and process efficiency. GAO Tek offers a plethora of viscometers, also known as rheometers, viscosity meters, and flow meters, tailored to different industrial needs. https://lnkd.in/eCTrak8v

⚙️🔍 Enhancing OSD Continuous Manufacturing with In Silico Assessment of the Robustness of MPC Frameworks 📊💊 The transition from traditional batch manufacturing to continuous manufacturing in the production of oral solid dosages has underscored the necessity for robust process models and control systems. This shift is particularly crucial in optimizing the manufacturing processes of pharmaceutical products, where maintaining consistent quality and efficiency is paramount. 🔬 This great paper by Ruben Waeytens , Daan Van Hauwermeiren , Wouter Grymonpré , Ingmar Nopens and Thomas De Beer presents a novel framework designed to assess the robustness of Model Predictive Control (MPC) in a Continuous Direct Compression (CDC) line, considering inherent process variability. The focus is on a continuous feeding-blending unit and a subsequent tablet press, employing a stochastic approach where model parameters are assigned probability distributions. Key Insights: 🔄 Stochastic Modeling: Integrates process variability by employing stochastic models, enhancing the predictiveness and reliability of the MPC. 🎲 Monte Carlo Analysis: Uses Monte Carlo simulations to evaluate the performance of the MPC under realistic feed rate disturbances and prediction errors. 🔎 Robustness Assessment: Demonstrates the significant impact of process variability on control strategies, highlighting potential risks of deterministic models. ✅ Real-World Application: Ensures greater transferability of control performance to actual manufacturing settings, incorporating realistic disturbances and error models. 📚 Link to Publication: https://lnkd.in/d3dr5Mxn #ContinuousManufacturing #ModelPredictiveControl #ProcessVariability #PharmaceuticalManufacturing #InSilicoAnalysis #PolyModelsHub

Particle Count: Particle count in injections refers to the presence of visible or subvisible particles in injectable products, which can compromise product quality, safety, and efficacy. Types of Particles: 1. Intrinsic particles: originated from the product itself (e.g., protein aggregates, crystalline particles) 2. Extrinsic particles: introduced during manufacturing, packaging, or handling (e.g., glass shards, metal fragments, fibers) Sources of Particles: 1. Raw materials (e.g., glass vials, rubber stoppers) 2. Manufacturing equipment (e.g., pumps, valves) 3. Packaging components (e.g., needles, syringes) 4. Handling and processing (e.g., filtration, filling) 5. Environmental contamination (e.g., air, water) Methods for Detection: 1. Visual inspection: manual examination under magnification 2. Microscopic analysis: using light or electron microscopy 3. Automated particle counting: using instruments like particle counters or flow cytometers 4. Subvisible particle analysis: using techniques like dynamic light scattering (DLS) or nanoparticle tracking analysis (NTA) Regulatory Guidelines: 1. USP (United States Pharmacopeia) <787> and <1787> 2. EP (European Pharmacopoeia) 2.9.19 3. FDA (Food and Drug Administration) guidance on particulate matter Acceptance Criteria: 1. Visible particles: absence of visible particles 2. Subvisible particles: limits on particle size and count (e.g., USP <787>) Impact on Product Quality: 1. Safety risks : particles can cause adverse reactions, toxicity, or immunogenicity 2. Efficacy concerns: particles can affect product potency or stability 3. Regulatory issues: non-compliance with guidelines can lead to product recalls or rejection Mitigation Strategies: 1. Raw material control: selecting high-quality materials and suppliers 2. Equipment design and maintenance: minimizing particle generation 3. Process optimization: controlling processing conditions and parameters 4. Packaging selection: choosing particle-free packaging components 5. Cleaning and sanitization: maintaining a clean and sanitized environment

Exciting news for pharmaceutical formulation development and process optimization! Introducing Tempris' TLM-3D Software, revolutionizing freeze-drying with 3D visualization in real-time of product temperature during the process. Discover the power of a digital twin of your freeze-dryer, which brings complex freeze-drying processes to life in 3D, real-time, and time-lapse mode. Tempris offers this cutting-edge software to expedite solution development, shorten process transfer times, and uphold quality through meticulous data analysis. But what does it mean for you? Pharmacists engaged in formulation development, transfer, or scale-up and engineers involved in tech transfer, MS&T, and CMC for process optimization stand to benefit greatly. TLM-3D Software provides comprehensive visualization of product temperature data, allowing for a deeper understanding of hot and cold spots and the various factors influencing temperature distribution. It highlights stored design space parameters for process deviations and facilitates data analysis at crucial interaction points. Key features include configurable vial types, sensor selection, and a customizable sensor loading plan. You can visualize process sequences with adjustable time-lapse settings and monitor critical parameters through the Design Space icon. Reporting functionalities ensure that insights gleaned from the software are documented for further analysis and decision-making. Excitingly, Tempris promises additional features in future releases, ensuring that TLM-3D Software remains at the forefront of freeze-drying innovation. Learn more about how our TLM-3D Software can accelerate your formulation development and process optimization: https://lnkd.in/ddAnhWAW #tempris #lyophilization #FreezeDrying #TLM3DSoftware #DigitalTwin #PharmaceuticalTech #ProcessOptimization #DataAnalysis #TechTransfer #TemperatureVisualization #PharmaEngineering #Tempris #ProductDevelopment #QualityControl

📈 Cut Costs and Enhance Accuracy with Electronic Batch Recording. 📽️ In our latest video, Uwe Rauschenberg, Track & Trace expert at Engineering Industries eXcellence, dives into the critical role of electronic batch recording in the pharmaceutical industry. Find out how to enhance regulatory compliance, quality control, product safety and supply chain integrity. 💊 1️⃣ Compliance: Meet global regulations with ease. 2️⃣ Quality Control: Trace every batch for ultimate product safety. 3️⃣ Error Reduction: Automate processes to eliminate manual mistakes. 4️⃣ Cost Savings: Cut costs and accelerate time-to-market. 5️⃣ Data Integration: Integrate EBR with existing systems for faster insights and decisions. Uwe breaks down how electronic batch recording not only ensures compliance but also delivers a seamless, automated process, reducing manual effort and boosting accuracy. Ready to revolutionize your pharma production? Watch the video and learn how electronic batch recording can transform your operations. 👉 Watch the full video now: https://lnkd.in/gGvbyXgx   Engineering Group Engineering North America Engineering Brasil Marco Steinkamp Uwe Rauschenberg Julian Stutley Brandon Johnson Mark Highhouse Jeff Martin Fabio Raffo Fabio Sala #Pharma #Manufacturing #Compliance #QualityControl #SupplyChain #pharmaceutical

In order to truly make #pharma adopt the power of #digitalisation models with a high predictive power are needed. In synergy with control algorithms they can make #continuous #manufacturing a reality which will be needed for transforming the sector towards #personalised #medicine which is the end the best solution for the #patient. Thanks to Fette Compacting for supporting this work. CESPE

🔬 Addressing the Challenges of Regular Visual Checks in Pharmaceutical Glass In the pharmaceutical industry, the integrity of glass containers is paramount. These containers are essential for storing and transporting medications, ensuring they remain safe and effective until they reach patients. However, regular visual inspections of pharmaceutical glass present several challenges that can impact the efficiency and reliability of these crucial quality checks. 🌟 High Precision Requirements Pharmaceutical glass must meet stringent quality standards. Even minor defects, such as small cracks, scratches, or foreign particles, can compromise the safety and efficacy of the product. Detecting these minute imperfections requires a high level of precision, often pushing the limits of human visual capabilities. 👓 Human Error and Fatigue Manual inspections are inherently prone to human error. Factors such as inspector fatigue, varying levels of experience, and subjective judgment can lead to inconsistent results. Fatigue, in particular, can significantly reduce an inspector's ability to detect defects over long periods, increasing the risk of faulty products slipping through the cracks. 💡 Technological Integration While automated inspection systems offer a solution, integrating these technologies into existing production lines can be complex and costly. Advanced imaging and sensor technologies need to be finely tuned to differentiate between acceptable variations and critical defects, requiring significant initial investment and ongoing maintenance. 🚀 Balancing Speed and Accuracy In high-volume production environments, there is a constant pressure to balance speed and accuracy. Automated systems need to operate at high speeds to keep up with production demands while maintaining the accuracy required to ensure product safety. Striking this balance is a continuous challenge, requiring ongoing optimization and quality assurance efforts. 🔄 Regulatory Compliance Adhering to regulatory standards adds another layer of complexity. Compliance with guidelines from authorities such as the FDA or EMA necessitates rigorous documentation and validation processes, which can be resource-intensive. Ensuring that both manual and automated inspection processes meet these stringent requirements is a perpetual challenge. Why not eliminate these risks and outsource these critical tests and checks to Glass Technology Services? Let's continue to drive improvements in this critical aspect of pharmaceutical manufacturing, ensuring that patients worldwide receive medications that are safe and effective. 💪 #PharmaceuticalIndustry #QualityControl #VisualInspection #PharmaGlass #Automation #RegulatoryCompliance #Innovation

🔬💊 Advancing Process Development for Fluid Bed Granulation in Pharmaceutical Manufacturing 📈 Fluid bed granulation is a critical step in tablet and capsule production, particularly when direct compression isn’t feasible due to poor powder flowability, ensuring that particles are adequately agglomerated to achieve the desired size and density in the final product. In this study, Salvador García Muñoz, Maitraye Sen, Shashwat Gupta, and Ronald Ruff introduce a hybrid model that integrates deterministic mass and energy balances with empirical granule growth modeling, providing a robust framework for understanding, optimizing and operating the fluid bed granulation process. 🌐 Key Technical Insights: - 🧩 Dynamic Hybrid Model Integration: The model combines mechanistic mass and energy balances with empirical granule growth modeling, effectively capturing the coupled dynamics of drying and granulation, which are critical for understanding water transfer and granule size evolution in the process. - 🧠 Systematic Assumptions and Driving Forces Analysis: Developed through meticulous formulation of assumptions and a detailed analysis of driving forces, the model accurately reflects the complex physical and chemical interactions within the granulation chamber, ensuring robust process representation. - 🔍 Advanced Parameter Estimability and Validation: The model employs sophisticated estimability techniques to reliably identify and validate critical parameters from available data, with Partial Least Squares (PLS) modeling enhancing its ability to analyze multivariate interactions, particularly for Loss on Drying (LOD) and powder bed temperature. - 📊 Sensitivity Analysis for Operational Decision-Making: Comprehensive sensitivity analysis allows for the assessment of how parameter variability impacts critical process outcomes, facilitating the optimization of operating conditions by understanding the influence of changes in parameters like airflow and spray rates on granule quality and drying performance. - ⚙️ Practical Validation with Real-World Data: The model’s predictions are validated against experimental data, including LOD and bed temperature profiles, demonstrating its applicability to real-world manufacturing scenarios and providing confidence in its utility for process scale-up and design space definition. 📚 Link to Publication: https://lnkd.in/dNi7Zu9S #PharmaceuticalManufacturing #FluidBedGranulation #ProcessModeling #PharmaceuticalEngineering #HybridModels