Rich Passanisi’s Post

Explore a streamlined approach to charge variant fractionation and LC-MS analysis of bispecific antibodies in this poster, presented by Peter Johnson at hashtag #CHIBioprocessingSummit. Download now: https://bit.ly/3XoXZBl

Some of the major themes of this update relate to drug product (DP) functional quality and manufacturing consistency including: 🔎 Optimal CAR detection is direct (and functional?): "We recommend direct detection of the CAR to determine the percentage of CAR-positive cells" (Page 11) 🎯 Higher bar for cross-reactivity studies potentially including "tissue cross-reactivity studies using a monoclonal antibody or fusion protein with the same antigen recognition domain" (Page 21) ✅ CQA identification / lot acceptance criteria: "we recommend that acceptance criteria be refined to ensure batches are well-defined and consistently manufactured." (Page 6) ⚔ Minimization of recombination events (Page 3) and independent confirmation of efficacy (Page 15) for multi-CAR product. Additional points: 🚫 If pre-treated with another CAR-therapy, “evaluation of the previously administered CAR T cell levels in the cellular starting material may be appropriate” (Page 4) -- which may remain difficult for competing companies to accomplish unless target antigen multimers are used! 👋 TCR repertoire analysis of pre-transduced cells may be a benefit to ensure consistent downstream biological activity: "Thus, nonclinical evaluation may include examination of uncontrolled proliferation, in vitro and in vivo testing for T cell clonality, karyotypic analysis, TCR repertoire analysis, and specificity for viral antigens through ex vivo stimulation and recognition assay" (Page 22) #KlickmerCART #fda

The latest FDA Guidance recommends the direct detection of the CAR to determine the percentage of CAR-positive cells.   Did you know that Dextramer® reagents may provide a sensitive solution for direct detection and quantification of CAR-positive cells by flow cytometry?   Using Dextramer® technology, our Custom Solutions and Services team can work with you to develop custom antigen multimers for detection of CAR-T cells.   Read the latest FDA Guidance for Industry released recently on “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products” via the link in the comments.   #CARTTherapy #fda #CellTherapy #Immunotherapy #flowcytometry

You’re probably missing functional epitopes by relying solely on screening antibodies using an affinity-based approach. Affinity-based methods often bias towards a few epitopes, limiting the identification of functional epitopes and potentially missing candidates with desirable qualities. Epitope binning, an early-stage screening process, addresses this by testing antibodies pairwise in a competition immunoassay. This identifies which antibodies block the same epitopes on a target antigen, maintaining epitope diversity and providing crucial information on antibody functionality. This allows for selecting the best-performing antibodies from each bin for further characterization, engineering, and optimization. Read our recent article on the importance of epitope binning in early-stage antibody discovery: https://hubs.li/Q02Cf5sc0 #AntibodyDiscovery #EpitopeBinning #SPR

Explore the structure, capabilities, and mechanisms of action for next-gen antibodies in our latest In Focus, supported by @SinoInc . Get an essential update on the field’s progress and discover the advantages and challenges of different modalities. Learn more! >>> https://bit.ly/48pnmpS

The Retrogenix cell microarray technology is the most powerful solution for identifying the specific human plasma membrane and secreted proteins that are targeted by antibodies, proteins, small molecules, viruses, CAR cells and other ligands. Let’s chat about how this platform can accelerate your program!

Are you working with Biosimilar antibodies? Check out our new expanded menu of Alexa Fluor and Alexa Fluor Plus conjugated Superclonal recombinant secondary antibodies which is now available! These new goat anti-human secondary antibodies are the perfect choice for accurate and precise detection. 🧪 Here's why our Superclonal recombinant secondary antibodies stand out: 🔬 Lot-to-lot consistency: Ensuring reliable results and reproducibility in your experiments. 🎯 Multiple epitope coverage: Enhancing sensitivity and specificity for robust detection. 💡 Accurate and precise detection: Providing confidence in your data and analysis. Learn more 👉 https://lnkd.in/gwnw8h4M #AlexaFluor #Invitrogen #SecondaryAntibodies #Superclonal #RecombinantAntibodies #biosimilars #thermofisherscientific

Shout out to CAR-T developers - last week FDA released a final guidance entitled "Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products". It finalises a draft guidance from 2022 and goes into non-clinical, clinical, and manufacturing expectations for autologous or allogeneic cells and summarises how to conduct analytical comparability studies with CAR-T products. The link to the 36 page guidance is here: https://lnkd.in/dW29ZHpP

Developing antibody variants? Get a strong start with this overview of purification strategies for bsAbs and fragments. Watch now: https://cytiva.link/gh56c

Developing antibody variants? Get a strong start with this overview of purification strategies for bsAbs and fragments. Watch now: https://cytiva.link/gh56c