SCIEX’s Post

Learn about measuring thermal stability, particle size, and polydispersity using the Zetasizer and NanoSight in this Lentivirus case study! Read it here 👇 We used the Zetasizer Advance Ultra Red and NanoSight Pro to investigate colloidal and morphological changes to the lentivirus structure after different storage conditions. Learn about: How the NanoSight Pro uses nanoparticle tracking analysis to measure nanoparticle size and concentration 🧪 How the Zetasizer Advance uses dynamic light scattering (DLS) to measure particle concentration and colloidal stability 💪 The role thermal stability can play in improving long-term stability of pharmaceuticals 💊 #Pharma #DLS #NTA

Developing and screening plasmid libraries is critical to biotherapeutic development. Maintaining plasmid libraries and preventing evolution is essential for consistent manufacturing. Learn how Danaher Life Sciences can help: https://bit.ly/4d3eHw8 #DanaherLifeSciences #pDNA #plasmid #drugdiscovery #drugdevelopment

An interesting topic covering application of X-Ray fluorescence in identifying and quantifying elemental impurities in pharmaceutical industry

Don’t miss this opportunity to take your drug purification process from this 🐌 to this 🚀 with energy dispersive X-ray fluorescence technology – sign up for our free webinar on 🗓 November 14 at 🕐 17:00 CET: Register now 👉https://lnkd.in/eGinYSQS Our expert Dr Natalia Dadivanyan will be talking with Gilead Sciences' Dr Sean K. Liew about: 💡 Why you don’t need to worry about safety when using EDXRF 💡 How it can help you better understand your reaction mixture purification strategies 💡 Troubleshooting unexpected outcomes by detecting trace contaminants … And more! #Pharma #XRF #EDXRF #XRayFluorescence

Host cell proteins (HCPs) are impurities produced during biotherapeutics manufacturing. While enzyme-linked immunosorbent assay (ELISA) is commonly used for overall HCP quantification, liquid chromatography–mass spectrometry (LC-MS) methods offer a complementary approach to profile individual HCPs, although they come with challenges. In this poster, we present case studies that highlights how we overcome challenges associated with LC-MS during downstream development. https://lnkd.in/gPe9wdEi #SamsungBiologics #cdmo #HCP #downstream #LC-MS 

The scientific leap taken in the development of therapeutic and prophylactic messenger ribonucleic acids (mRNA), and the increased public acceptance of the more recently available mRNA-related biopharmaceuticals, have propelled the search for new analytical methodologies for their characterization. Among these techniques are the determination of the incorporation efficiency of the cap structure onto the 5'-terminus of the mRNA. The measurement of this critical quality attribute (CQA) involves liquid chromatography/mass spectrometry (LC/MS) yet is hampered by the tendency of nucleic acids to adsorb to the iron surfaces of columns and instruments, especially when using hydrophilic interaction chromatography (HILIC) instead of ion pair reversed-phase (IP-RP) LC. As demonstrated in this application note, this phenomenon can be counteracted by opting for low-adsorption LC flow paths using a polyether ether ketone (PEEK)-lined HILIC column and an Agilent 1290 Infinity II Bio LC System. Read more:

Charge heterogeneity analysis…Raising the Bar! Charge heterogeneity is an intrinsic property of the biologics. It’s detail investigation is a routine but arduous task in the biotech fraternity. #Ion #exchange #chromatography (#IEX) is the main work horse for charge variant analysis owing to its applicability at analytical scale as well as at preparative scale in downstream operations. However, it offers a limited resolution of charged species. #CZE and #iCIEF are popular techniques orthogonal to #IEX and are characterized by high resolving power and simple instrumentation. Either of these techniques can have several advantages over IEX in investigating charged variants of monoclonal antibodies (#mAbs) and #bispecific antibodies (#BsAb). In this report #Maximilian Meudt et. al. describes improvised #CZE and #iCIEF methods for #mAbs and #BsAbs. For #CZE (#SCIEX PA 800 Plus, Beckman Coulter), authors have formulated a new buffer system comprising background electrolyte and alternative dynamic coating agents (#Spermine, #PEO-100 i.e. #polyethylene oxide) was optimized. In case of #iCIEF (Protein Simple iCE3), a new ampholyte combination that contained #NDSB-195 (#non-detergent #sulfobetaine) offering a highly linear pH gradient, covering a suitable pH range and better protein solubilization was optimized. Don’t miss the supplement! Citation: #Maximilian Meudt, Martin Pannek, Nina Glogowski, Fabian Higel, Katharina Thanisch, Matthias J. Knape. (2024) CE methods for charge variant analysis of mAbs and complex format biotherapeutics. Electrophoresis. Volume 45, Issue15-16 Pages 1295-1306. DOI: 10.1002/elps.202300170

Charge variant analysis is an essential part of monoclonal antibody characterization. Modifications of a single amino acid can dramatically affect antibody activity. Learn how Phenomenex BioZen columns can help reproducibly decipher heterogeneity in protein samples: https://bit.ly/3UexHPk

Keeping track of and measuring host cell proteins (HCPs) during the production of biotherapeutics is vital for maintaining the quality, stability, and safety of the product. The use of liquid chromatography–mass spectrometry (LC–MS) analysis has become a key method for the identification and measurement of specific HCPs. In this recent paper from scientists at Merck, they utilize the Evosep One coupled to a Bruker Daltonics timsTOF Pro 2 to overcome the challenges of host cell protein (HCP) analysis. By leveraging diaPASEF, they were able to reveal the presence of more than 600 additional HCPs previously missed by DDA PASEF, and reduce carryover while increasing the overall throughput. #hcp #proteomics #biotherapeutics #diapasef

It's always refreshing to be reminded of the science happening in the lab right now. Here are a few experiments currently being conducted: Residual Volatile Organic Impurities by headspace gas chromatography Drug Product Identification Testing by FT-IR Spectroscopy, NMR and 2D NMR spectroscopy Drug Product Powder X-ray Diffraction In-Process Control Reaction Completion, Purity, and Assay Analysis via UPLC Identity, Assay, and Purity by Reversed-Phase UPLC Appearance of samples Reaction product workup by flash chromatography and preparatory HPLC Biologics stability testing by size-exclusion chromatography, capillary electrophoresis-SDS and thermal shift Formulation screening Forced degradation testing In-vitro expression and screening Biologics stability screening by LCMS-qTOF Protein purification with FPLC Thanks Jake Hostetler for mentioning these last week.