The Pathfinder #29 - Reimagining Pharma: Unveiling the Secrets to Robust Processes, Biologics Control, and the Rise of Continuous Manufacturing
Welcome to The Pathfinder's weekly newsletter, where we explore the exciting world of regulatory drug development!?Follow us on LinkedIn
Introducing?ENKRISI ?–?the leading consulting group helping organizations comply with drug regulations through a comprehensive drug development model incorporating augmented intelligence (AI) and data analytics.
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Step into the captivating world of regulatory approval and revolutionize your approach with these groundbreaking articles. Volume 64 - "Designing Robust Processes During Development: A Roadmap for Success" unravels the complexities of developing robust processes in the pharmaceutical industry. It emphasizes comprehensive understanding, Quality by Design (QbD) principles, risk management, process validation, and continuous improvement. Real-life examples showcase the transformative impact of well-planned processes.
Vol 65 - In "Case Studies: Developing a Robust Control Strategy for Biologics," we explore real-world examples highlighting the importance of controlling critical process parameters, conducting risk assessments, and implementing real-time process monitoring. These case studies reveal solutions for ensuring biologic manufacturing quality, efficacy, and safety.
Vol 66 - The rise of continuous manufacturing (CM) is reshaping the pharmaceutical industry. This blog explores innovations in CM, such as real-time quality control, AI and machine learning optimization, and modular and portable systems. Industry case studies demonstrate the successful implementation of these innovations, promising efficient, flexible, and high-quality drug production.
Join us as we explore the dynamic and ever-changing world of regulatory drug development in this week's newsletter! Please share as you see fit!
"Designing Robust Processes During Development: A Roadmap for Success" explores the complex and challenging task of developing robust processes in the pharmaceutical industry. From small molecules to biologics and dosage forms, each product type presents unique obstacles that must be overcome to ensure safety, efficacy, and high-quality standards. The blog emphasizes the importance of comprehensive understanding, adopting Quality by Design (QbD) principles, effective risk management, thorough process validation, and continuous improvement. It highlights real-life examples and successful implementations in small molecule, biologics, and dosage form process development, showcasing the transformative impact of well-planned and meticulously executed processes.
Revolutionizing the field of medicine, biologics offer innovative treatments derived from living organisms. In the blog "Case Studies: Developing a Robust Control Strategy for Biologics," we delve into real-world examples that shed light on the importance of controlling critical process parameters, conducting risk assessments, and implementing real-time process monitoring. Through these case studies, we uncover the challenges faced in biologic manufacturing and the solutions employed to guarantee the quality, efficacy, and safety of these groundbreaking pharmaceutical products.
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The pharmaceutical industry is undergoing a significant transformation with the rise of continuous manufacturing (CM). This blog explores the innovations in CM and their impact on drug development. Real-time quality control, enabled by Process Analytical Technology (PAT) tools, allows for immediate adjustments and improved product quality. Artificial Intelligence (AI) and machine learning optimize process parameters, enhance efficiency, and provide predictive capabilities. Modular and portable systems offer flexibility and scalability, catering to the production needs of small-volume, high-value drugs. Case studies from industry leaders such as GlaxoSmithKline, AstraZeneca, Pfizer, Janssen, and Eli Lilly highlight the successful implementation of these innovations. Continuous manufacturing is shaping the future of drug development, promising more efficient, flexible, and high-quality production. The pharmaceutical industry must stay informed and adaptable to thrive in this evolving landscape.
The PathFinder
The Regulatory Intelligence Newsletter - Enkrisi’s Intelligence Newsletter
What is The PathFinder?
The PathFinder is a Regulatory intelligence newsletter publication that provides Lifesciences organizations with up-to-date information on current and upcoming regulations. The PathFinder focuses on relevant topics such as regulatory developments, compliance trends, legal updates, enforcement actions, industry insights, and best practices. Experts in the field write articles to ensure accuracy and help sponsor companies stay informed about changes in their regulatory environment.
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Introducing ENKRISI?– the leading consulting group helping organizations comply with drug regulations through a comprehensive drug development model incorporating augmented intelligence (AI) and data analytics. Our team of industry experts is equipped to help both emerging biotechs and established pharmaceuticals understand how to use AI and machine learning to stay on top of rapidly changing regulatory requirements. We're here to help navigate the complex world of compliance more manageable than ever!?
Stay tuned for more information on how Enkrisi can help you navigate the complex world of compliance and regulatory intelligence in the pharmaceutical industry complex world of compliance and regulatory intelligence.