HORIBA for Life Science’s Post

Protein Loss During Membrane Processes in Biopharmaceutical Manufacturing This study aims to provide a comprehensive analysis of protein loss in the range of membrane systems used in downstream processing including clarification, virus removal filtration, ultrafiltration/ diafiltration for formulation, and final sterile filtration, all using commercially available membranes with three model proteins (bovine serum albumin, human serum albumin, and immunoglobulin G). The correlation between protein loss and various parameters (i.e., protein type, protein concentration, throughput, membrane morphology, and protein removal mechanism) was also investigated. This study provides important insights into the nature of protein loss during membrane processes as well as a methodology for quantifying protein yield loss in bioprocesses. https://lnkd.in/dZymkF7n #aspenalert #biotech #bioprocess

Paper review: Reversible protein complexes: Advancing subcutaneous delivery with controlled and sustained release of high concentration biologics https://lnkd.in/e33yMVVJ #drugdiscovery #drugdevelopment #drugdelivery

As the fastest growing sectors of the pharmaceutical industry, most therapeutic proteins have complex post-translational modifications for efficient secretion and drug efficacy and stability maintenance. PTMs can affect the activity, stability, and function of a protein. Misfolding, aggregation, variable glycosylation, oxidation of methionine, deamination of asparagine and glutamine, and proteolysis are common types of protein modifications. Incorrect modifications of protein therapeutic may result in immune response, or even serious side effects. These modifications pose a great challenge for accurate and consistent bioprocessing and a comprehensive analysis of protein modifications is a necessary. #protein #proteinmodification #drugdevelopment #posttranslationalmodifications #pharmaceuticalindustry #drugsidcovery Image from creative proteomics

Lyophilization preserves delicate formulations and therapeutic molecules, but its success depends on precise temperature control. Learn about the lyophilization process and how thermal analysis plays a critical role in this new blog: https://lnkd.in/evBGRTHe #Pharma #DrugDevelopment #PharmaIndustry

Here Starovoit et al describes a methodology to overcome in high temperature in column artifacts for LCMS peptide analysis 🛎Overview: High-temperature liquid chromatography (HTLC) has an important drawback. In that peptides can go unwanted modifications due to the exposure to high temperature and an acidic mobile phase while on the column 🎯Summary: Starovoit et al method employs a trapping column which is maintained at a lower temperature to keep peptides safe for a considerable amount of time before they finally elute from the separation colum. Starovoit et al observed increased peak capacity by 1.4-fold within a 110 min peptide mapping of trastuzumab and provided 10% more peptide identifications in exploratory LC–MS analyses compared with analyses conducted at 30 °C Futhermore Starovoit et al observed method reduced temperature-related artifacts by 66% for N-terminal pyroGlu and 63% for oxidized Met compared to direct injection at 60 °C. #massspectrometry #massspectrometry #biotherapeutics #biotech #chemistry #pharmacy #pharma #peptide https://lnkd.in/eGsuyQMd

Interested in learning more? Click here to download the whitepaper ➡️ https://lnkd.in/eqR_mgvt, and contact ProAnalytics LLC to learn more! #raman #bioprocessing #downstream #purification #mAb

As the demand for biosynthetic pharmaceuticals like therapeutic monoclonal antibodies skyrockets, so does the need for effective process monitoring tools for protein purification. Unfortunately, traditional methods and sensors fall short in providing comprehensive data. Enter High-Throughput Raman Process Monitoring - a game-changing technology that offers real-time molecular and quantitative analysis to improve process efficiency and increase profits. Interested in learning more? Download the whitepaper today! https://lnkd.in/eqR_mgvt #PharmaceuticalRamanTechnology #RealTimeProcessMonitoring #ProteinPurification

The demand for peptide-based drugs is rapidly increasing. Tens of peptide products are currently on the market, and hundreds more are in preclinical or clinical development. A class of peptide medication garnering attention is glucagon-like peptide-1 (GLP-1) analogs, which mimic the action of the natural hormone GLP-1 receptor agonists that regulate blood sugar levels. Initially approved for diabetes treatment, these peptides now exhibit the potential to address obesity and other health issues. The manufacturing of peptide drugs presents significant sustainability challenges. Therapeutic peptide manufacturing is a prime example of pharmaceutical production where solvents account for approximately 85-90% of the total mass of materials. In this blog, we provide a perspective on these challenges. https://lnkd.in/geqNhyJ9

Sharing our blog about the sustainability challenges in peptide manufacturing. The peptide drug market has experienced significant growth in recent years, and this upward trend will continue in the coming years. This growth, along with the increased use of GLP-1 analogs like Liraglutide and Semaglutide to treat diabetes and obesity, is expected to increase production demand significantly. However, this increased demand presents a severe challenge to the sustainability of peptide manufacturing, as the average peptide manufacturing batch size is growing yearly. Current industrial-scale peptide synthesis methods involve using substantial quantities of hazardous reagents and solvents. The widespread use of chromatography to purify peptide products also contributes to poor sustainability. Estimates show that peptide production produces tons of waste per kilogram of produced peptide. This wastage leads to very high process mass intensity (PMI), the ratio of the total mass of all input material over the mass of isolated product, and the cost of goods. Our blog covers these issues.

I am excited to share a new high-temperature LC-MS method recently published by our team. This innovative approach maintains the benefits of elevated column temperatures while greatly minimizing peptide modification and degradation during reversed-phase liquid chromatography. Key Benefits: 1.     Enhanced Separation: Achieve superior chromatographic resolution without sacrificing separation quality. 2.     Reduced Modifications: Significantly mitigate artificial peptide modifications, ensuring reliable data interpretation. 3.     Increased Identifications: Boost your peptide identification rates by up to 10% in exploratory LC-MS analyses. 4.     Improved Quality Control: Reduce temperature-related artifacts by 66% for N-terminal pyroGlu and 63% for oxidized Met, enhancing the accuracy of biopharmaceutical analysis. 5.     Easy Implementation: Seamlessly integrate our method into your existing LC-MS workflows with minimal adjustments. Our approach leverages a short, near-ambient-temperature trap column upstream of the separation column, shortening peptide residence time in the heated separation column. This innovative setup maintains the benefits of high column temperatures while protecting the peptides from degradation and modification. https://lnkd.in/dPaQkt6W