Léa Valla’s Post

Do you know about Bispecific ADCs (BsADCs)? They are a promising new bioconjugated modality which capitalize on the advantages of Bispecific mAbs when it comes to ADC’s challenges with drug resistance, poor internalization, or off-target specificity. Read this review to learn about strategies and considerations to optimize the development of novel BsADCs. See publication: https://lnkd.in/e3JgqfV9

In this study, we aim to combine the separation power of chromatographic and electrophoretic tools (LC–CE) so as to achieve maximum resolution of mAb charge variants. HIC has been used as the preferred LC mode with CE for achieving successful separation of both charge and hydrophobic variants for two of the mAbs (trastuzumab and rituximab). The HIC–CZE–UV method resolved 29 variants in mAb A and 23 variants in mAb B, far superior than conventional analytical approaches. https://lnkd.in/dgXghP2V

Bispecific antibody‒drug conjugates (BsADCs) combine the strengths of ADCs and BsAbs. BsADC could be positioned as the next-generation ADC approach.Challenges are poor internalization, off-target toxicity, and drug resistance. https://lnkd.in/gXxmmY-D

The FDA and the CRCG are thrilled about our upcoming workshop on "Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products," happening on October 7-8, 2024 and we hope to see you there. Register Now! https://lnkd.in/gpPu_jsf In session 4, presenters will discuss regulatory pathways for recombinantly manufactured peptide products and strategies for immunogenicity risk mitigation using an in vitro approach. More specifically, immunogenicity risk assessment of host cell proteins as potential contaminants in peptide drug products. Also discussed in this session will be alternative models for immunogenicity risk assessment. #generics #genericdrugs #Immunogenicity Montserrat Puig, Vibha Jawa PhD FAAPS, Nicolas Gaudenzio, Emilee Knowlton, Ph.D., Kristina Howard, Sophie S.

🚨 Final Call! 🚨 We’re just one week away from the FDA and Center for Research on Complex Generics (CRCG) Workshop on October 7-8, 2024! Dr. Nicolas Gaudenzio, our Chief Scientific Officer will take the stage to present Genoskin’s cutting-edge technology for drug product assessment. 📢 Key highlight: Our innovative approach, combining next-gen sequencing with immunocompetent human skin models, enhances the accuracy of predicting biological responses to injectable therapies. This technology, recently featured in Allergy EAACI 2024, is transforming how we study human skin reactions long before clinical trials. If you're in biotech or pharma, this is a must-attend session to learn how our platform can de-risk your drug development process and ensure safer outcomes. 🔗 Register today: https://lnkd.in/gpPu_jsf #Immunogenicity #DrugDevelopment #ClinicalTrials #Genoskin #FDAWorkshop #NextGenSequencing #oligonucleotides#peptides#genericdrugs  

A NRF2 inhibitor selectively sensitizes KEAP1 mutant tumor cells to cisplatin and gefitinib by restoring NRF2-inhibitory function of KEAP1 mutants, Tahar Aboulkassim et al. Cell Reports Reports 2023. This is impressive. Conversely we have made molecules that repair the abberant binding v of Nrf2-KEAP1 due to somatic KEAP1 mutation. These mutations result in constitutively high Nrf2, and resistance to many cancer therapies, by virtue of the cytoptotective gene batter in regulates. This chemistry is advancing quickly; improving pritein-protein interaction.

Working with ADCs? Here are 4 useful tips to make sure your Antibody survives the conjugation process! #ADC #drugdiscovery #biologics

MK-0616: “I Was Told.. an Oral PCSK9 Inhibitor is Impossible” | https://lnkd.in/gmYxYD43 -2023 Molecule of the Year Nominee (#1/10)- Merck's macrocyclic PCSK9 protein-protein interaction (PPI) inhibitor, MK-0616, is a once-daily PCSK9-lowering and LDL-cholesterol-lowering small molecule that has recently demonstrated antibody-like efficacy as an oral agent in the clinic. The program highlights numerous technical achievements at the forefront of modern drug discovery, from mRNA display screening to the use of lipidic permeation enhancer formulations, and will set a standard for modern “classics in drug discovery” for some time. In this case study, we review the drug discovery campaign leading to MK-0616 from hit-finding to clinical development, highlighting why this molecule continues to be a “big deal” and a standard for modern “classics in drug discovery.” Article | https://lnkd.in/gmYxYD43

And... Another Epi-Pub! This time - #PANDA (peptide #ANDA) for Salmon #Calcitonin - a #Generic Peptide drug. With Eric Pang, Daniela Verthelyi, Brian J. Roberts, PhD, and Sandra LELIAS. Find out how we screen peptide #Impurities in silico and in vitro. Sign up and to get the proof hot-off-the-press... https://lnkd.in/eYrM_Ppy

Monoclonal antibodies (mAbs) are at the forefront of drug development with the demand increasing for high-quality, scalable productions. To meet the demand, we proudly present the GramExpress platform — your solution for large-scale, premium-quality mAb production. Leveraging our ultra-high titer transient expression system and flexible purification processes, the unique GramExpress service offers premium-quality mAbs ranging from 1-100 grams in just 3-4 weeks. ➡️Key Features of GramExpress Service: • Utilizes ultra-high titer WuXian™ Transient expression • Delivers 1-100 g mAbs in 3-4 weeks • Premium-quality (purity >98%, endotoxin <0.2 EU/mg) Learn More: https://shorturl.at/ekvMR #wuxibiologics #gramexpress #proteinsciences #monoclonal #anttibodies #monoclonalantibodies #researchrevolution #drugdevelopment