Corden Pharma - A Full-Service CDMO’s Post

FDA Seeks Input on its Innovative Manufacturing Technology Strategy The US FDA this week released a draft of its strategic plan to promote the uptake of innovative manufacturing technologies for drugs and biologics. The plan fulfills a mandate of the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals for Fiscal Years 2023-2027 (PDUFA VII) to advance the implementation of innovative manufacturing. It was prompted by the feedback the agency received at its June 8, 2023 public meeting on the use of innovative manufacturing technologies for products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), as well as the barriers impeding their adoption. https://lnkd.in/g4nwXMmD #aspenalert #biotech #bioprocess

Esophageal Drug Delivery: What Are the Main Conventional and Novel Approaches? For further information, interested readers are referred to a comprehensive updated review article entitled "Current status and advances in esophageal drug delivery technology: influence of physiological, pathophysiological and pharmaceutical factors" https://lnkd.in/d_pRFHHR #CDMO #NDDS #Value_added_pharmaceuticals #Pharmaceutical_research #Bioequivalency #Formulation

Don't miss out! Register here: https://bit.ly/3Wx3I8q to join us tomorrow, Wednesday, May 22, at 12pm ET for a free webinar, deep-diving the LDT final rule, as well as key takeaways not just for LDT stakeholders, but the potential anticipated impacts on the diagnostics, medical devices, pharmaceutical and biopharmaceutical sectors. #AgencyIQ #Politico #LifeSciences #Regulatory #Regulation #FDA #LDT #Webinar

Metrohm does not have one but TWO handheld Raman instruments for RMID! MIRA P is the premier 785nm compliant Raman system. It is a pocket-sized powerhouse for precise, high-specificity discrimination of similar materials- from different batches or vendors, for example. Orbital Raster Scan (ORS™️) provides sensitive interrogation without consuming, damaging, or burning the sample. Discover how MIRA P can help you: https://bit.ly/49TJARu #MetrohmRaman #Metrohm #Raman #RamanSpectroscopy #Spectroscopy #HandheldRaman #RealWorldRaman #MetrohmMeansSpectroscopy #RamanSolutions #MetrohmSpectro #MIRA #MIRAP #Pharma #Pharmaceutical #Pharmaceuticals #RMID #Compliant #RawMaterials #RamanForRMID

I am giving a webinar tomorrow on the FDA's LDT final rule! If you're interested in diagnostics policy, the drug development impacts, the future of CDx or what we expect to happen next - or just want to watch me talk at breakneck speed while using more acronyms than we really should in conversation - please join us! Register here -> https://bit.ly/3Wx3I8q

CLEANING OF EQUIPMENT - overview of different equipment cleaning methods used in the pharmaceutical and biologics industries. Follow SKILLPAD - digital learning for life sciences on LinkedIn at https://lnkd.in/eZt4kHw for more news and updates. Description and screenshots here: https://lnkd.in/g48BT_Bj Schedule your DEMO here: info@skillpad.com #pharma #pharmaceuticals #gmp

The world of API development can be complex and the ever-changing clinical environment gives rise to numerous challenges. 🗻 One major obstacle is managing the poor physicochemical properties of many drug candidates emerging from discovery. The Biopharmaceutical Classification System (BCS) plays a large role in defining these challenges and manipulating BCS Class II and IV is a key strategy to enhance fundamental properties. 💊 Discover more by downloading our latest whitepaper.👇 https://loom.ly/Yo4bY_Q #Chemistry #Pharma #DrugDevelopment

The HDA Research Foundation recently released a report titled “The Future of the U.S. Pharmaceutical Cold Chain.” Register for our LinkedIn Live on 6/27 to discover key findings from the report and learn what success drivers will shape the future of the cold chain market: https://bit.ly/4cr4Z5t

Raw material identification (RMID) plays a critical role in ensuring the quality and safety of products in the pharmaceutical and biopharmaceutical industries. However, traditional RMID approaches often involve multiple time-consuming steps, leading to production bottlenecks and potential risks to material quality. Join us on Thursday as our expert, Adam J. Hopkins, PhD, shows us how to build simple, compliant workflows to reduce quarantine time and presents tools that accelerate your RMID process from day one. Register here: https://bit.ly/3wPtSZj #MetrohmRaman #Metrohm #Raman #RamanSpectroscopy #Spectroscopy #HandheldRaman #RealWorldRaman #MetrohmMeansSpectroscopy #RamanSolutions #MetrohmSpectro #RMID #RawMaterialIdentification #Pharma #Pharmaceuticals #MIRAP #NanoRam #NanoRam1064 #Compliant #Webinar