Yokogawa Fluence Analytics’ Post

❓ “Recently, regulatory authorities asked my company to document that downstream purification of our biologic reduces specific enzymes added during process development. Is there a reproducible method that detects process-related impurities down to low ppm levels?” ❗ Yes! SWATH mass spectrometry (LC-MS/MS) is a highly sensitive and reproducible approach that can identify and quantify residual proteins through all purification steps, including the final drug product. You can use SWATH LC-MS to track specific residuals throughout the entire process development, compare batches, and perform quality control after upscaling. A process-specific assay can be developed within just a few weeks, and the high sensitivity makes it possible to quantify impurities even at low ppm levels. This approach is ideal for analyzing process-related residuals in biologics development and is increasingly important to FDA and EMA. ⬇️ Read this blog post by Ejvind Mørtz to learn more about this game-changing method for residual protein analysis. ⬇️

Recombinant and synthetic peptides carry the risk if inducing unwanted immune responses like any other biologic and despite being regulated as small molecules. Using the same principles applied in the immunogenicity risk assessment of biologics can be used to define your predictive in vitro studies. https://lnkd.in/e_9uB2wf #immunogenicity #riskassessment #recombinantpeptides #synthethicpeptides #ANDA

The guidance document that Laura Inés Salazar Fontana has kindly posted and in there is a comment from Krishna Allamneni are both super helpful for this topic!

Read how to improve bioanalytical PK workflows with up to 10x higher sensitivity. The Gyrolab® 2G Generic PK Kit is designed to help labs save time and resources.⏳ #Biotech #Bioanalysis #pharmacokinetics https://lnkd.in/gNf6tTiu

Visit the oligonucleotide virtual lab to find complete workflow solutions for the analysis and characterization of oligonucleotides Explore the Agilent Oligonucleotide Workflow https://lnkd.in/dX3Hs-vj Oligo Therapeutics: https://lnkd.in/dRCjzFWw Synthetic oligonucleotides (including small interfering RNA, antisense oligonucleotides, aptamers) have become fast-growing modalities in recent years. With the development of these candidates comes the increased need for robust analytical methods and easy-to-use data analysis workflows to characterize them. Commonly sought-after attributes of oligonucleotides include the mass, purity (and relative quantity of impurities present), and sequence. #oligonucleotides #cellandgenetherapy #biopharmaceuticals #pharmaceuticals #impurities #rawmaterials #qualitycontrol #manufacturing #mrnavaccines

In this article, scientists from Thermo Fisher Scientific and Bristol Myers Squibb (BMS) describe their efforts to define mechanisms of virus removal during a polishing step based on POROS HQ chromatography resin (Thermo Fisher), a strong anion exchanger. #purification #downstreamprocessing #monoclonalantibodies #chromatography #bioprocessing

📢 Scientific Poster Our poster, "Cell Culture Process Development to Reduce High Mannose Glycans in mAb Production" was presented at Chinese Antibody Society conference. Cell culture process development serves as the crucial link in biologics CMC. MAN5 glycan is known to potentially affect the safety and efficacy of biopharmaceuticals. AsymBio’s process development team developed a new and effective cell culture approach which can significantly reduce MAN5 content by up to 78% for a molecule with a high starting MAN5 level of over 30%. The approach demonstrates effectiveness on MAN5 reduction, which can be generally applied for different IgG molecules and numerous projects. To download the poster, please visit: https://lnkd.in/dHtacBGj #asymbio #cellculture #cmc #IgG #antibody #processdevelopment #biologics

Dive into the fascinating world of bioconjugates, where we combine the strengths of biologics and small molecules to create innovative therapeutic solutions. What are Bioconjugates? Bioconjugates are engineered compounds that link a biologic (like antibodies) to small molecules or drugs, enhancing their efficacy and targeting capabilities. This synergy opens new avenues for treating complex diseases. Read the full article here: https://lnkd.in/gGNg9ga6 #Bioconjugates #Biologics #Pharmaceuticals #DrugDevelopment #HealthcareInnovation #Artixio

💥 Our expert team confronts the "no treatment" and "no cure" reality by screening and validating effective treatments for #rarediseases at unbeatable speed. We deploy our cutting-edge patented technologies to provide reliable and scalable transgenic models paired with validated phenotypic assays to secure effective treatments for many #neurodegenerativediseases. In our latest blog, we dive into the details of how we have impacted #DravetSyndrome therapeutic advancement. See the full blog post here: https://lnkd.in/g-4yc8JK #genetics #geneticresearch #neurodegeneration #epilepsy #epilepsyresearch #seizures #pharmaceuticals #biopharma #pharma #innovation #biotechnology #scn1a #scn2a #dravet #autism #alzheimers

Endonucleases play an essential role in biomanufacturing by degrading contaminating DNA and RNA during the production of biologics such as virus-based vaccines. #ProblemStatement: Traditional endonucleases, while useful in various biomanufacturing applications, often exhibit decreased functionality in high-salt conditions, a common challenge during the production of biologics like Adeno-associated and lentiviruses. #TheSolution – Salt-Tolerant Endonucleases: Salt-tolerant recombinant endonucleases have been engineered to overcome these limitations. Through amino acid modifications and enzyme engineering, these enzymes maintain their activity in high-salt environments, facilitating processes such as the degradation of DNA and the purification of non-enveloped viruses like AAVs. #Bioprocessing #Endonucleases #SaltTolerantEnzymes #Biomanufacturing #RecombinantEnzymes #ViralVectorProduction #AAVProduction #BiologicsManufacturing #EnzymeEngineering #HighSaltConditions #DNAremoval #BioprocessOptimization #GeneTherapyProduction