Padidela Swarochish Rao ®’s Post

NMR Coupled with Multivariate Data Analysis for Monitoring the Degradation of a Formulated Therapeutic Monoclonal Antibody The function of a protein is directly coupled to its higher-order structure (HOS). Deviations in this critical quality attribute (CQA) may be linked to a decrease in the efficacy and/or safety of the final therapeutic product. High-resolution nuclear magnetic resonance (NMR) spectroscopy has been recently highlighted for protein HOS characterization, thanks to its ability to capture small changes at the molecular and structural levels (primary, secondary, tertiary and quaternary). The present study was carried out to demonstrate the ability of NMR (1D 1H and 2D 1H-13C experiments) coupled with multivariate data analysis (PCA and PLS regression) to monitor the degradation of a formulated mAb-like protein and for the simultaneous quantification of related CQAs, i.e., potency, purity and impurities (aggregates and fragments). The results indicate that this approach could be applied to mitigate product quality risks during development, manufacturing and stability studies of mAb therapeutics. https://lnkd.in/gZhF6uwm #aspenalert #biotech #bioprocess

What are the top takeaways from Day 2 of the PDA - Parenteral Drug Association #visualinspection Forum? (Bonus points for identifying the happy guys in this photo.)

USP- NF New:  〈1762〉 Solid-State Nuclear Magnetic Resonance Spectroscopy—Theory and Practice. The #solidstatenuclearmagneticresonance (#ssNMR) spectroscopy is an emerging technique for the characterization of #pharmaceuticalsolids. Its broad range of applications in pharmaceutical analysis includes solid form identification and quantitation in #drugsubstances (DSs), #drugproducts, and #excipients, as well as physical and chemical profiling of dosage forms. ‼️One of the key advantages of ssNMR is its versatile capabilities to provide highly informative data in a noninvasive, quantitative, and high-resolution manner. Unlike many other techniques used to characterize pharmaceuticals in the solid state, ssNMR can be used to study nondestructively and non-invasively both DSs and drug products, and it can provide quantitative information about different forms of DS without the need for standards. ‼️Another significant advantage of ssNMR is its ability to provide structural information about both crystalline and amorphous forms and its usefulness in investigating the molecular dynamics of the system. 👎Despite its many advantages, ssNMR has limitations, including long analysis times, required expertise and specific training, and the need for expensive instruments, which may limit its accessibility. These challenges often limit the use of ssNMR to cases where the desired information cannot be obtained by other methods. 👍However, ssNMR is an invaluable tool for pharmaceutical analysis, enabling: ✅Unambiguous identification of polymorphs ✅Identification and quantitation of formulation ingredients ✅High confidence in the low-level quantification of multicomponent solids ✅High-resolution investigation of structure and dynamics The applications of ssNMR have grown to the point where a general chapter that focuses on ssNMR spectroscopy is warranted. Therefore, the Chemical Analysis Expert Committee is proposing the following new informational general chapter about ssNMR spectroscopy. ➡️ The aim of this new chapter is to discuss the fundamental principles and practical applications of ssNMR spectroscopy in pharmaceutical systems. It is written for pharmaceutical scientists who characterize materials in the solid state.  This chapter is divided into three main parts: 1️⃣The first part focuses on the theory of ssNMR relevant to pharmaceutical applications. It assumes some basic knowledge of NMR theory, and it is recommended that the reader be familiar with the basic theory found in Applications of Nuclear Magnetic Resonance Spectroscopy 〈1761〉. 2️⃣The second part focuses on the basic instrumentation and approaches needed to perform ssNMR. 3️⃣The last part focuses on the ssNMR applications to pharmaceutical solid Below the link to USP website https://lnkd.in/dQ_U8Xwi If you like this post follow me on LinkedIn

𝐓𝐡𝐞𝐫𝐚𝐧𝐨𝐬𝐭𝐢𝐜𝐬 𝐌𝐚𝐫𝐤𝐞𝐭 𝐆𝐫𝐨𝐰𝐭𝐡 𝐅𝐨𝐫𝐞𝐜𝐚𝐬𝐭 - $4.3 𝐁𝐢𝐥𝐥𝐢𝐨𝐧 𝐛𝐲 2028 Download PDF Brochure @ https://lnkd.in/ddsm9Be4 The global 𝐭𝐡𝐞𝐫𝐚𝐧𝐨𝐬𝐭𝐢𝐜𝐬 𝐦𝐚𝐫𝐤𝐞𝐭 𝐢𝐧 𝐭𝐞𝐫𝐦𝐬 𝐨𝐟 𝐫𝐞𝐯𝐞𝐧𝐮𝐞 𝐰𝐚𝐬 𝐞𝐬𝐭𝐢𝐦𝐚𝐭𝐞𝐝 𝐭𝐨 𝐛𝐞 𝐰𝐨𝐫𝐭𝐡 $2.1 𝐁𝐢𝐥𝐥𝐢𝐨𝐧 𝐢𝐧 2023 𝐚𝐧𝐝 𝐢𝐬 𝐩𝐨𝐢𝐬𝐞𝐝 𝐭𝐨 𝐫𝐞𝐚𝐜𝐡 $4.3 𝐁𝐢𝐥𝐥𝐢𝐨𝐧 𝐛𝐲 2028, 𝐠𝐫𝐨𝐰𝐢𝐧𝐠 𝐚𝐭 𝐚 𝐂𝐀𝐆𝐑 𝐨𝐟 15.5% from 2023 to 2028 Key market players are adopting various growth strategies to strengthen their foothold in this region. For instance, in August 2019, Eckert & Ziegler (Germany) initiated a joint venture with Chengdu New Radiomedicine Technology Co., Ltd. (China) to set up a new production facility for radiopharmaceuticals used in the treatment of hepatocellular carcinomas in China. According to an article published in the European Journal of Nuclear Medicine and Molecular Imaging 2022, by 2025, about 50 new centralized radiopharmacies will be built across China, and the availability and accessibility of radiopharmaceuticals will be significantly improved by then. Advanced Accelerator Applications , Bayer | Pharmaceuticals, GE HealthCare 𝐊𝐞𝐲 𝐌𝐚𝐫𝐤𝐞𝐭 𝐏𝐥𝐚𝐲𝐞𝐫𝐬

We have an immediate opening for an experienced Medicinal Chemist (Staff or Senior Postdoc depending on experience) to design, synthesize and optimize novel compounds to modulate Nuclear Receptors and Drug-metabolizing Enzymes, using our current chemical scaffolds, ligand-protein co-crystals, and SAR data as starting points. This is an exciting opportunity to collaborate with a team of experienced biologists and structural biologists and bring our research to the next levels. If interested (or known someone who are interested), please forward CVs to me (taosheng.chen@stjude.org). Research Summary: Drug toxicity and resistance are the leading causes of therapeutic failures. The Chen Lab (https://lnkd.in/dWMm_-am) studies: (1) the chemical regulation of nuclear xenobiotic receptors, (2) the molecular basis of signal crosstalk among nuclear receptors, and (3) the mechanism of selective modulation of highly homologous drug-metabolizing enzymes. We are taking a hypothesis-driven and technology-enabled multidisciplinary approach to develop chemical probes and investigate biological mechanisms. In particular we use the promiscuous pregnane X receptor (PXR) and constitutive androstane receptor (CAR) as models. PXR and CAR transcriptionally regulate cytochrome P450 3A4 (CYP3A4) and CYP3A5—drug-metabolizing enzymes that metabolize more than 50% of clinical drugs, the dysregulation of which contributes to drug toxicity and drug resistance. We have developed the first selective PXR antagonist (Nat Commun 8:741, 2017; Nat Commun 15:4054, 2024); established that PXR and CAR form an unexpected heterodimer (Nucleic Acids Res 50:3254, 2022); revealed a mechanism that expands PXR’s ligand binding pocket to reduce ligand’s binding affinity (Proc Natl Acad Sci U S A. 120: e2217804120, 2023); and discovered the first CYP3A5-selective inhibitor and its structural basis (J Am Chem Soc 143:18467, 2021). Our goal is to understand nuclear receptor-regulated transcription networks, enzyme-drug interactions, and design therapeutic approaches to overcome drug resistance and toxicity in cellular and animal models.

The Theranostics market is Projected to Grow at a CAGR of 15.5% 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐏𝐃𝐅 𝐁𝐫𝐨𝐜𝐡𝐮𝐫𝐞:-https://lnkd.in/d6W9bTeW The global theranostics market in terms of revenue was estimated to be worth $2.1 Billion in 2023 and is poised to reach $4.3 Billion by 2028, growing at a CAGR of 15.5% from 2023 to 2028. 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐏𝐫𝐨𝐟𝐢𝐥𝐞𝐬 𝐈𝐧 𝐭𝐡𝐢𝐬 𝐑𝐞𝐩𝐨𝐫𝐭 Advanced Accelerator Applications (France), Bayer AG (Germany), GE Healthcare (US), etc 𝐎𝐭𝐡𝐞𝐫 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐎𝐩𝐞𝐫𝐚𝐭𝐢𝐧𝐠 𝐢𝐧 𝐭𝐡𝐢𝐬 𝐌𝐚𝐫𝐤𝐞𝐭 𝐆𝐥𝐨𝐛𝐚𝐥𝐥𝐲 Advanced Accelerator Applications Bayer GE HealthCare Siemens Healthineers Cardinal Health Philips Canon Inc. Curium Pharma Lantheus NorthStar Medical Radioisotopes, LLC Eckert & Ziegler SE Pharmalogic Eczacıbaşı-Monrol Nuclear Products Acrotech Biopharma Inc Thermo Fisher Scientific Global Medical Solutions SHINE Technologies Isotopia Molecular Imaging ltd Institute of Isotopes Co. Ltd. China Isotope & Radiation Corp Yantai Dongcheng Pharmaceutical Group Co., Ltd AtomVie Global Radiopharma Inc. ABX advanced biochemical compounds GmbH Telix Pharmaceuticals Limited Blue Earth Diagnostics Sofie Biosciences, Inc. Theragnostics

Studying protein structure, dynamics, and interactions is key to growing our understanding of disease mechanisms. In this article, Tatyana Polenova (University of Delaware) discusses the use of nuclear magnetic resonance (NMR) spectroscopy, particularly solid-state magic angle spinning (MAS) NMR, for high-resolution analysis of dynamic protein structures, crucial for understanding disease mechanisms and drug development. You can find it in Wiley Analytical Science (WAS): https://lnkd.in/dAYrhMRy Or you can read it directly in the WAS magazine here (page 45): https://lnkd.in/d-xVhBFm #NMR #AnalyticalScience #Proteins #Pharma

𝗧𝗵𝗲𝗿𝗮𝗻𝗼𝘀𝘁𝗶𝗰𝘀 𝗠𝗮𝗿𝗸𝗲𝘁 𝗙𝗼𝗿𝗲𝗰𝗮𝘀𝘁𝗲𝗱 𝘁𝗼 𝗪𝗼𝗿𝘁𝗵 $4.3 𝗕𝗶𝗹𝗹𝗶𝗼𝗻 𝗯𝘆 2028 𝗗𝗼𝘄𝗻𝗹𝗼𝗮𝗱 𝗣𝗗𝗙 𝗕𝗿𝗼𝗰𝗵𝘂𝗿𝗲-https://lnkd.in/dPYYBcnK The global theranostics market in terms of revenue was estimated to be worth $2.1 Billion in 2023 and is poised to reach $4.3 Billion by 2028, growing at a CAGR of 15.5% from 2023 to 2028. 𝐌𝐚𝐢𝐧 𝐊𝐞𝐲 𝐏𝐥𝐚𝐲𝐞𝐫𝐬: Advanced Accelerator Applications Bayer GE HealthCare Siemens Healthineers Cardinal Health Philips Canon Inc. Curium Pharma Lantheus NorthStar Medical Radioisotopes, LLC Eckert & Ziegler SE Pharmalogic Eczacıbaşı-Monrol Nuclear Products Acrotech Biopharma, INC Thermo Fisher Scientific Global Medical Solutions SHINE Technologies Isotopia Molecular Imaging ltd Institute of Isotopes Co. Ltd. China Isotope & Radiation Corp Yantai Dongcheng Pharmaceutical Group Co., Ltd AtomVie Global Radiopharma Inc. ABX advanced biochemical compounds GmbH Telix Pharmaceuticals Limited Blue Earth Diagnostics Sofie Biosciences, Inc. Theragnostics

Theranostics Market worth $4.3 billion by 2028 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐅𝐫𝐞𝐞 𝐒𝐚𝐦𝐩𝐥𝐞 𝐑𝐞𝐩𝐨𝐫𝐭- https://lnkd.in/dYZ_Tegs The global theranostics market in terms of revenue was estimated to be worth $2.1 Billion in 2023 and is poised to reach $4.3 Billion by 2028, growing at a CAGR of 15.5% from 2023 to 2028. Advanced Accelerator Applications Bayer GE HealthCare Siemens Healthineers Cardinal Health Philips Canon Inc. Curium Pharma Lantheus NorthStar Medical Radioisotopes, LLC Eckert & Ziegler SE Pharmalogic Eczacıbaşı-Monrol Nuclear Products Acrotech Biopharma Inc Thermo Fisher Scientific Global Medical Solutions SHINE Technologies Isotopia Molecular Imaging ltd Institute of Isotopes Co. Ltd. China Isotope & Radiation Corporation Industrial Source Center Yantai Dongcheng Pharmaceutical Group Co., Ltd AtomVie Global Radiopharma Inc. ABX advanced biochemical compounds GmbH Telix Pharmaceuticals Limited Blue Earth Diagnostics Sofie Biosciences, Inc. Theragnostics

The Theranostics market is Projected to Grow at a CAGR of 15.5% 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐏𝐃𝐅 𝐁𝐫𝐨𝐜𝐡𝐮𝐫𝐞- https://lnkd.in/dYZ_Tegs The global theranostics market in terms of revenue was estimated to be worth $2.1 Billion in 2023 and is poised to reach $4.3 Billion by 2028, growing at a CAGR of 15.5% from 2023 to 2028. 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐏𝐫𝐨𝐟𝐢𝐥𝐞𝐬 𝐈𝐧 𝐭𝐡𝐢𝐬 𝐑𝐞𝐩𝐨𝐫𝐭 Advanced Accelerator Applications (France), Bayer AG (Germany), GE Healthcare (US), etc 𝐎𝐭𝐡𝐞𝐫 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐎𝐩𝐞𝐫𝐚𝐭𝐢𝐧𝐠 𝐢𝐧 𝐭𝐡𝐢𝐬 𝐌𝐚𝐫𝐤𝐞𝐭 𝐆𝐥𝐨𝐛𝐚𝐥𝐥𝐲 Advanced Accelerator Applications Bayer GE HealthCare Siemens Healthineers Cardinal Health Philips Canon Inc. Curium Pharma Lantheus NorthStar Medical Radioisotopes, LLC Eckert & Ziegler SE Pharmalogic Eczacıbaşı-Monrol Nuclear Products Acrotech Biopharma Inc Thermo Fisher Scientific Global Medical Solutions SHINE Technologies Isotopia Molecular Imaging ltd Institute of Isotopes Co. Ltd. China Isotope & Radiation Corp Yantai Dongcheng Pharmaceutical Group Co., Ltd AtomVie Global Radiopharma Inc. ABX advanced biochemical compounds GmbH Telix Pharmaceuticals Limited Blue Earth Diagnostics Sofie Biosciences, Inc. Theragnostics