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Elevate your pharma production game! ?? Discover how real-time monitoring and control systems can transform your processes, ensuring quality remains the top priority. Ready to boost your readiness? Let’s take production to the next level! ???? #pharmaproduction #realtimemonitoring #qualitycontrol

Process intensification and continuous bioprocessing two terms being thrown around as part of an ongoing strategy to improve the the quality and yields of products from biopharma and bioprocess. However - these words are often not well defined. Let's take a minute to put some structure around each. Process intensification is a holistic framework to maximize overall productivity of the unit operation(s), or the manufacturing process, or the facility output for biomanufacturing. It enables faster drug development, increases the efficiency and productivity in GMP, and is applicable to any process irrespective of molecule. Continuous bioprocessing for upstream operations in the pharma industry is often defined as the process of running a bioreactor at a fixed volume and fixed cell concentration for 30 to 90 days (or longer) with a constant flow of cell culture media, giving a constant harvest volume to be processed. https://lnkd.in/ggB2AjD

https://lnkd.in/gxy-kQVf The disclosed process optimization details for the second-generation manufacturing route of adagrasib provide a comprehensive perspective on the advancements achieved in the production methodology. By strategically addressing various key objectives throughout the development phase, the optimization efforts have significantly enhanced multiple facets of the manufacturing process. Firstly, the focus on controlling difficult-to-purge impurities in the key starting materials (KSMs) underscores a commitment to ensuring the purity and quality of the final product. This attention to detail at the initial stages of the process lays a solid foundation for subsequent steps, minimizing potential complications and ensuring consistency in product quality. Moreover, the emphasis on scalability of the KSM reflects a forward-looking approach, anticipating the need for increased production capacity to meet growing demand. Scalability is crucial for long-term sustainability and market competitiveness, enabling the seamless transition from laboratory-scale synthesis to commercial-scale manufacturing. The optimization efforts also targeted specific reaction steps, such as improving pyrimidone formation of the core and enhancing the robustness of oxidation. These enhancements not only streamline the synthesis pathway but also contribute to greater process efficiency and reliability, reducing the likelihood of yield variability or unexpected deviations. Furthermore, the enhanced stability of the step 3 intermediate highlights a critical aspect of process optimization – ensuring the integrity and stability of intermediate compounds throughout the synthesis chain. Stability improvements minimize the risk of degradation or side reactions, thereby increasing overall process efficiency and yield. The decision to remove the halogenated solvent in the fourth step demonstrates a commitment to sustainability and environmental responsibility. By eliminating potentially harmful solvents, the optimized process aligns with modern regulatory standards and reflects a conscientious approach to manufacturing practices. Finally, the implementation of single crystallization for the final API streamlines the purification process, simplifying downstream operations and reducing resource consumption. This optimization not only improves overall process efficiency but also contributes to a significant reduction in the cost of goods, ultimately enhancing the economic viability of adagrasib production. In summary, the disclosed process optimization details showcase a holistic approach to enhancing the manufacturing route of adagrasib, encompassing improvements in purity, scalability, reaction efficiency, stability, environmental impact, and cost-effectiveness. These advancements not only drive efficiency and reliability in production but also underscore a commitment to continuous improvement and innovation in pharmaceutical manufacturing.

???????????????????????? ?????????????? ???????????????????? ???????????????? ?????? ???????????????? ???? ???????????? ?????? ?????????????? Routine monitoring of cleaning processes in pharmaceutical and biotechnology manufacturing is crucial to ensure product safety and regulatory compliance. Key steps include developing and validating cleaning procedures, routine sampling and testing, data analysis, and continuous improvement. Common sampling methods involve swabbing, rinsing, and visual inspections, while AI-driven software can enhance efficiency and accuracy. Ensuring effective cleaning procedures helps prevent cross-contamination, maintains product quality, and meets FDA guidelines. ?????? ???????????????? ????????????????, ?????????? ?????? ???????? ??????????????: https://lnkd.in/gBcKCZ3H Participate in the Cleaning Process & Validation Conference on November 7-8, 2024, in Munich or online. This event is essential for professionals in pharmaceutical manufacturing to enhance their knowledge of cleaning validation, ensuring compliance with regulatory standards. Attendees will gain insights from industry leaders on the latest cleaning techniques, risk assessments, and digitalization of cleaning processes. The conference offers an opportunity for networking and learning from real-world case studies. ?????? ???????? ?????????????? ?????? ????????????????????????, ?????????? https://lnkd.in/da4z3R6h Speak Pharma VTI Life Sciences David Vincent, CEO/ B.Sc., MPH, PhD #SpeakCleaning #CleaningValidation #PharmaHygiene #IndustrionHygiene #CIPAdvantages #RiskAssessment #ManufacturingQuality #ValidationStrategies #PracticalApplications #CollaborativeLearning #QA #Digitalization #CleanByDesign #CIP #COP #Annex

Join us for an insightful live webinar ??, “Safeguarding Planning in Pharmaceutical Production through Simulation,” on November 21, 2024, at 3:00 PM (Central European Standard Time). Discover how simulation-supported optimization during the planning phase can help reduce initial investments, streamline workflows, and enhance facility layouts ??. In this session, Miebach Consulting will showcase how Tecnomatix Plant Simulation enables pharmaceutical companies to model and optimize production systems, minimizing costly errors and improving operational efficiency. Gain insights from industry leaders on leveraging digital tools to make strategic, well-informed decisions that boost productivity and reduce financial risks. Don’t miss this opportunity to learn about proven strategies that ensure compliance, efficiency, and success in pharmaceutical manufacturing. Secure your spot today to start planning smarter! https://sie.ag/cr8Ad

Join us for an insightful live webinar ??, “Safeguarding Planning in Pharmaceutical Production through Simulation,” on November 21, 2024, at 3:00 PM (Central European Standard Time). Discover how simulation-supported optimization during the planning phase can help reduce initial investments, streamline workflows, and enhance facility layouts ??. In this session, Miebach Consulting will showcase how Tecnomatix Plant Simulation enables pharmaceutical companies to model and optimize production systems, minimizing costly errors and improving operational efficiency. Gain insights from industry leaders on leveraging digital tools to make strategic, well-informed decisions that boost productivity and reduce financial risks. Don’t miss this opportunity to learn about proven strategies that ensure compliance, efficiency, and success in pharmaceutical manufacturing. Secure your spot today to start planning smarter! https://sie.ag/cr8Ad

Join us for an insightful live webinar ??, “Safeguarding Planning in Pharmaceutical Production through Simulation,” on November 21, 2024, at 3:00 PM (Central European Standard Time). Discover how simulation-supported optimization during the planning phase can help reduce initial investments, streamline workflows, and enhance facility layouts ??. This session will showcase how Tecnomatix Plant Simulation enables pharmaceutical companies to model and optimize production systems, minimizing costly errors and improving operational efficiency. Gain insights from industry leaders on leveraging digital tools to make strategic, well-informed decisions that boost productivity and reduce financial risks. Don’t miss this opportunity to learn about proven strategies that ensure compliance, efficiency, and success in pharmaceutical manufacturing. Secure your spot today to start planning smarter! https://sie.ag/cr8Ad

In pharmaceutical continuous manufacturing (PCM), technical solutions ensuring critical quality attributes for content uniformity and unit dose exist for online, in-line, and at-line measurements. Process analytical technology (PAT) allows in-line measurement and control of critical process parameters (CPP) that impact a product’s critical quality attributes (CQA).1?When applying quality by design (QbD) principles it is possible to define a process design space for a unit operation and integrate real-time process analytics into pharma and biopharma manufacturing processes. This creates the opportunity for real time release testing (RTRT) to replace conventional end-product testing, potentially saving a drug sponsor facility environmental control costs, inventory carrying costs, and testing costs for product release. As PAT sensor technology has evolved and matured, so have the approaches to implementation. Today’s best practices simplify the approach to using PAT as part of an RTRT strategy and help drug sponsors avoid complexity that can impact overall equipment effectiveness (OEE). By Richard Steiner, practice lead, Pharmatech Associates, a USP company #continuousmanufacturing #tablets #pharma #processequipment #PAT Source: Pharmaceutical Online, Fette Compacting America, Inc, Fette Compacting, Pharma Technology, Bruker, Coperion K-Tron

Achieve right-first-time pharma manufacturing with Process Analytical Technology (PAT) and SIMATIC SIPAT software. This powerful combination enables real-time quality monitoring and seamless integration with existing systems for improved process understanding and enhanced decision-making. Learn more today! https://sie.ag/4kWm2x #Pharma #SmartManufacturing

Baxter S.A. sought to streamline its operations, manage operating costs, and conform to the U.S. Food and Drug Administration’s compliance standards. To achieve these goals, Baxter needed to revise its manufacturing facility processes to incorporate automation methods into a new production line. Baxter partnered with BiiON, which specializes in pharmaceutical and biotechnology industry system integration, to ensure the successful implementation of the new manufacturing line. With its new system in place, Baxter’s facility simplified monitoring and reporting, ensured regulatory compliance, and doubled production. ? “To be successful, strategic projects require excellent collaboration between the customer, the software vendor, and the integrator. By establishing the automation framework, AVEVA software enabled our project teams to focus on productivity targets.”? Serge Bassem, CEO, BiiON Goals Increasing production capacity while reducing manufacturing throughput time Incorporating automation in a new production line to comply with U.S. FDA regulations Challenge Keeping automation system compatible with existing architecture and systems Centralizing production management to include reporting, analysis and traceability Ensuring performance monitoring complies with US and European standards Solutions AVEVA? InTouch HMI ?AVEVA? System Platform AVEVA? Batch Management AVEVA? Historian Results Doubled productivity at the manufacturing facility Manufacturing processes are fully traceable and comply with US and European regulations New generic objects library simplifies batch management