Pharma Ed Resources Events ’s Post

“Retro QbD and CPV: how to control and to leverage process knowledge on your legacy products?” is the topic of the workshop co-hosted by Expleo, and more specifically by Nathalie Bricard, our quality and regulatory expert, at the forthcoming A3P Association international congress for global players in the pharmaceutical industry taking place from the 8th to the 10th of October 2024 🔬⚙️. Key takeaways from the workshop will be: ▫️ The benefits and risks of a retro Quality by Design (QbD) approach ▫️ How to implement this approach: the steps to follow and what to avoid ▫️ Continuous Process Validation (CPV) 👉 To learn more about our life sciences offerings go to https://expleo.to/3ZuGktt #Pharma #Biotech #Lab #LifeScience #Engineering #Technology #Innovation

Understanding your combination product Reviewer's level of training and the tools in their FDA toolbox will better equip you for creating an effective submission and setting up positive agency interactions. Our team of former FDA Reviewers have shared their inside scoop on this subject in our ever-growing "How to build a successful combination product program" article. Check out this week's installment here: https://lnkd.in/ggDAgEsb #combinationproduct #drugdelivery #devicedevelopment #fda #fdareviewer #pharma #biotech #medtech

Draft Guidance for Industry: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products IS OUT! SCI is excited to announce our team’s latest endeavor, a comprehensive white paper on the FDA Draft Guidance: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products – COMING SOON! This pivotal document delves into the intricacies of industry standards and offers insightful guidance for the development of combination products in line with the latest draft guidance. Stay tuned for its release and discover the cutting-edge strategies for incorporating this into your development programs. Keep checking our LinkedIn page, or sign up for our emails [https://lnkd.in/gA4ngeWi], for quick insights on the Draft Guidance leading up to the release of our white paper on Sutton Creek’s thoughts and application of its contents. Link to Draft Guidance: https://lnkd.in/eE_GW3Fz #CombinationProducts, #EDDO, #EPR #DrugDelivery #FDA #pharma #biotech #medtech #drugdelivery #drugdeliverydevice

 Here is what you missed in the last edition of the training course, 'Development and Validation of Bioassays.' During the course, participants explored guidance on developing analytical procedures, which is critical for various aspects of bioassay design. Join us for the upcoming edition, starting from March 18th to 20th, and explore essential #statisticaltools, and relevant regulations, and also learn how to design reliable bioassays. The program features real-world examples and case studies to help you strengthen your knowledge and avoid common mistakes. We have limited slots available, so register today to secure your spot. #drugdevelopment #bioassays #analyticalmethods #ICHQ14 #symmetrictraining #pharmaceuticals #biotechnology

Exploring the Science Behind Moisture Management in Pharmaceuticals: Unveiling the Crucial Role of Excipients! In the intricate realm of pharmaceuticals, excipients are the unsung heroes, safeguarding drug stability amidst the challenges posed by moisture. Discover the secrets of moisture management and the pivotal role played by excipients in our latest blog post: Read more: https://hubs.li/Q02hz3r10 Key Takeaways: Excipients' Crucial Role: Learn how excipients contribute to drug stability, efficacy, and protection from moisture. Starch 1500® Advantage: Discover why Starch 1500 is a preferred excipient, offering stability, low water activity, and bound moisture advantages. Download Now: https://hubs.li/Q02hz2tt0 Elevate your understanding of moisture management in pharmaceuticals with our insightful exploration! #Pharmaceuticals #MoistureManagement #Excipients #DrugFormulation #Starch1500

📢 Regeneron Slashes AAV Costs with New Method! 🌟 Regeneron has streamlined AAV manufacturing by eliminating endonuclease. This change cuts costs and enhances scalability. 💰 The savings per batch can reach $100,000, helping to align therapy costs with payer budgets. 🔬 The team achieved impressive yields, matching traditional methods, but with greater efficiency. The innovation also simplifies raw material sourcing and reduces additional assays. ⚙️ Key improvements include salt addition to boost filtration. #BioprocessUpdates #Regeneron #AAVManufacturing #Endonuclease #GeneTherapy #BiotechInnovation #CostSavings #Scalability #Efficiency #Pharmaceuticals #Biomanufacturing #HealthcareInnovation #RawMaterialSourcing #FiltrationTechnology #TherapyCosts #LifeSciences ▷ Read the full article here: 📎 https://lnkd.in/dfMBqZUA

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Yesterday, on June 24th, we announced the signing of an asset purchase agreement with CanAm Bioresearch Inc. for the acquisition of the patent and intellectual property related to the discovery of new chemical entities. Medicure believes that the new chemical entities hold promise to provide improvements over existing lead compounds in alignment with the treatment of diseases being targeted by Medicure, and could provide significant value upon completion of all required non-clinical and clinical studies and regulatory approval. These new chemical entities are not being applied in Medicure's current Phase 3 study evaluating the use of MC-1 for the prevention or treatment of seizures associated with pyridox(am)ine 5'-phosphate oxidase (PNPO) deficiency. Read the full Press Release here: https://lnkd.in/eJJfJPu7 #Bioscience #PressRelease #Medicure #WeBringMedicineToLife #AHeartForLife #pharmaceutical

Every year, thousands of promising drug candidates face abandonment due to solubility and bioavailability challenges. In this article Catalent experts discuss the ways companies can address issues with low bioavailability, and the benefits of enlisting an experienced drug development partner. https://ow.ly/6uoW50Qz9UQ

Exploring the Science Behind Moisture Management in Pharmaceuticals: Unveiling the Crucial Role of Excipients! In the intricate realm of pharmaceuticals, excipients are the unsung heroes, safeguarding drug stability amidst the challenges posed by moisture. Discover the secrets of moisture management and the pivotal role played by excipients in our latest blog post: Read more: https://hubs.li/Q02hz3r10 Key Takeaways: Excipients' Crucial Role: Learn how excipients contribute to drug stability, efficacy, and protection from moisture. Starch 1500® Advantage: Discover why Starch 1500 is a preferred excipient, offering stability, low water activity, and bound moisture advantages. Download Now: https://hubs.li/Q02hz2tt0 Elevate your understanding of moisture management in pharmaceuticals with our insightful exploration! #Pharmaceuticals #MoistureManagement #Excipients #DrugFormulation #Starch1500