WuXi Biologics’ Post

Clinical In-Use (CIU) studies are typically conducted during biotherapeutic development to assess the stability and compatibility of the biological product with administration components and/or diluents. These studies simulate product use in clinical practice, generating experimental data to ensure patient safety and product efficacy during administration. Our Clinical In-Use Center of Excellence (CIU CoE) offers comprehensive services, including customized study design for multiple administration routes, analytical testing across a wide dosing range from ng to mg, an extensive inventory of diverse CIU consumables, and global support for IND & BLA filings. https://lnkd.in/eUQJugYB #drugproducts #drugformulation #drugproductdevelopment

Clinical In-Use (CIU) studies are typically conducted during biotherapeutic development to assess the stability and compatibility of the biological product with administration components and/or diluents. These studies simulate product use in clinical practice, generating experimental data to ensure patient safety and product efficacy during administration. Our Clinical In-Use Center of Excellence (CIU CoE) offers comprehensive services, including customized study design for multiple administration routes, analytical testing across a wide dosing range from ng to mg, an extensive inventory of diverse CIU consumables, and global support for IND & BLA filings. https://lnkd.in/eUQJugYB #drugproducts #drugformulation #drugproductdevelopment

Clinical In-Use (CIU) studies are typically conducted during biotherapeutic development to assess the stability and compatibility of the biological product with administration components and/or diluents. These studies simulate product use in clinical practice, generating experimental data to ensure patient safety and product efficacy during administration. Our Clinical In-Use Center of Excellence (CIU CoE) offers comprehensive services, including customized study design for multiple administration routes, analytical testing across a wide dosing range from ng to mg, an extensive inventory of diverse CIU consumables, and global support for IND & BLA filings. https://lnkd.in/eUQJugYB #drugproducts #drugformulation #drugproductdevelopment

  atai Life Sciences (NASDAQ:ATAI, ETR:9VC) co-founder and co-CEO Dr Srinivas Rao takes Proactive's Stephen Gunnion through the positive results from the Phase 1b trial for VLS-01, emphasizing its excellent tolerability and potential as a best-in-class treatment option. The trial revealed that the formulation exceeded expectations, particularly in terms of pharmacokinetics, with results comparable to intravenous administration. VLS-01 is being developed for treatment-resistant depression, a condition that impacts the lives of an estimated 100 million people globally. Srinivas emphasizes the potential of VLS-01 as a best-in-class treatment option, with excellent tolerability, patient-friendly administration and a short 2-hour in-clinic treatment time. The trial revealed that the formulation exceeded expectations, particularly in terms of pharmacokinetics, with results comparable to intravenous administration. Rao... Watch at #Proactive #ProactiveInvestors http://ow.ly/3fqe105Fnmb

"Exploring the Importance of GMP in Pharma: Insights from My Latest Review Article" Proud to share my recent review article on Good Manufacturing Practice (GMP) in the pharmaceutical industry! 🌟 In this piece, I explore the crucial role GMP plays in ensuring the quality and safety of pharmaceutical products. As a recent graduate eager to contribute to the industry, I believe that understanding and adhering to these standards is key to advancing public health. I welcome feedback and would love to connect with others who share an interest in maintaining high standards in pharma. #GMP #PharmaceuticalIndustry #QualityAssurance #PublicHealth"

Kits to site. Samples to lab. The basics of what the team at CellCarta Logistics is accountable for. #clinicaltrials #samplemanagement #cellcarta

Navigating regulatory seas? Let Velsera be your compass! The FDA's final rule is shaking up the landscape for laboratory-developed tests (LDTs) by enforcing the same standards as traditional in vitro diagnostic (IVD) devices. While ensuring patient safety is key, this brings financial and administrative challenges, especially for CLIA-certified or CAP-accredited labs. The FDA is phasing out enforcement discretion over four years, with some exceptions. Curious about how to navigate these changes? Dive into our latest blog post to discover: 🔸 How to get started 🔸 Key compliance insights 🔸 Practical steps to keep your lab ahead of the curve Velsera is committed to supporting our partners through these molecular diagnostic laboratory operations changes. With decades of experience in complex testing support, regulatory compliance, LDT performance validation, and clinical-grade software solutions, we are dedicated to delivering safe and innovative molecular diagnostic tests globally. Don't miss out on this essential guide to navigating these new waters. — Click the link below to read more and get tips on preparing your lab for the future! https://lnkd.in/giEZDXSv #EraofVelsera #FDAfinalrule #LDTs #precisionmedicine

[WEBINAR] - Explore the development of nasal dosage forms and the success factors required to achieve rapid prototype selection for clinical evaluation in this webinar with Chief Scientific Officer, Richard Johnson. Learn more about the key topics covered and watch now ⬇ https://lnkd.in/ees4VxRB #CDMO #DrugDevelopment #Webinars

⭐ New for you - Enhancing oral drug delivery: Exploring multiparticulate systems with Thermo Fisher Scientific⭐ 📅 14th August 15:00PM BST 👨🔬 Discover the intricacies of multiparticulate systems, exploring their design, benefits, and the issues they are uniquely positioned to solve, particularly for oral drug delivery. You'll also benefit from viewing case studies illustrating applications of multiparticulate systems as well as taking part in a Q&A with our speaker. Register now >> https://bit.ly/3Vulk2e #DrugDelivery #Formulation #ClinicalDevelopment

🎉 Exciting news in medical diagnostics! COPAN Diagnostics, Inc. has received FDA clearance for UriSponge, an innovative urine collection and transport device. This advanced system is set to revolutionize urine specimen handling in clinical laboratories. Key features of UriSponge: • Uses a new advanced preservative formulation for specimen stability • Simplifies collection with a quick dip-and-close method • Ensures sample integrity without precise fill lines • Integrates with laboratory automation systems like WASP Fabrizio Mazzocchi, CEO of COPAN Diagnostics, Inc. states: "UriSponge provides a reliable and efficient solution that supports laboratory needs while offering healthcare providers a safe, streamlined process". UriSponge is expected to be available through U.S. distribution partners in early 2025. This innovation promises to enhance laboratory productivity and consistency, marking a significant step forward in microbiology specimen processing. https://lnkd.in/eWU52sFw 📰 Stay ahead in healthcare by following Practical Patient Care on LinkedIn! Get the latest news and insights on patient care and clinical advancements. Join our community to stay informed and enhance your knowledge. Follow us today! #PracticalPatientCare #MedicalInnovation #LaboratoryEfficiency #CopanDiagnostics #UriSponge