Omega Therapeutics’ Post

⚙️ Harnessing the Power of Bispecific Soluble Receptors⚙️ Fab Biopharma’s bispecific soluble receptors stand out not only for their therapeutic potential but also for their manufacturing efficiency. By requiring only a single gene for expression — compared to the four needed for bispecific antibodies — we streamline production and ensure greater stability during scale-up. This innovative approach reduces complexity, accelerates development timelines, and enhances the therapeutic profile of our treatments. Read more about the potential of bispecific soluble receptors in our latest article: https://lnkd.in/eG8BgmbN   #DrugDevelopment #WomensHealth #BiopharmaInnovation #LifeSciences

Social Pharma Patient-Centric Marketing socialpharma.net >>> Gene&Cell Therapy >> JPM recap: Where the money is in biotech, alternative upturn indicators and more #lucidquest #genetherapy #celltherapy

Stay ahead of the curve in the evolving world of cell and gene therapies with insights from Andelyn Biosciences! Our newsletter is packed with industry updates, expert discussions, and exclusive content. In our latest edition, don’t miss the featured webinar where Samir Acharya, Associate Director of Process Development, discusses upstream and downstream variables and how flexibility in the AAV Curator™ Platform addresses these issues in practical application. Sign up for our newsletter today to stay up to date on these critical discussions and more: https://buff.ly/3ZRv6zl #CellAndGeneTherapy #AAV #GeneTherapy #Biotech #Pharma #Quality #ProcessDevelopment #Webinar #AndelynBiosciences

Intellia with positive results for hereditary angioedema... The company announced reductions in swelling attacks in their Ph2 trial of NTLA-2002. The company leverages mRNA to deliver CRISPR components to knockout the KLB1 gene. https://lnkd.in/gmzwDE7j This is a competitive space with other nucleic acids in development (Ionis' ASO donidalorsen in Ph3), as well as the likes of Argo Bio and ADARx, in addition to mainstay treatments like the mAb Takhzyro. BUT... a CRISPR-based knockout could be a "one-and-done" type treatment. We'll be seeing more of this "one and done" vs. a regularly dosed therapy in the near future so we'll see how these dynamics play out in the market. Game on! #pharma #drugdevelopment #genetherapy

📚 ISPE, a leading industry organization, has recently published a guide that addresses common challenges that may arise when demonstrating comparability across the rAAV product lifecycle. Their newest release, "rAAV Comparability & Lifecycle Mgmt," provides valuable insights into the complex and rapidly evolving world of gene therapy manufacturing. 🔗 Learn more from the guide here: https://lnkd.in/gF5mJQxY 🗣️ Share your thoughts and experiences in the comments below. Connect with us at https://www.brevitas.us/ #genetherapy #manufacturing #lifecyclemgmt #ISPE #ATMPs #comparability #pharmaceuticals #Brevitas

Long-term follow-up (LTFU) studies are an important component of gene therapies, but they present unique challenges for biotech and emerging biopharma. A tailored, patient-centric approach can provide the solution. Download the IQVIA Biotech Insight Brief to learn more. https://bit.ly/4cL70JX #CAGT #GeneTherapy #biotech

Continuing from our post earlier this week, we would like to reintroduce you to our PPQ master plan.    You can download this here: https://lnkd.in/ebA4iYKJ    The PPQ master plan document outlines a general strategy for manufacturing processes expected to undergo process performance qualification with considerations unique to gene therapies.     The detailed content will help identify gaps or additional considerations within existing PPQ master plans or serve as a resource for plans related to initial PPQ campaigns.    For companies with established quality systems and process validation experience, this document may serve to identify gaps or additional considerations when modifying existing validation templates for GT products. For those with limited validation experience, it is intended to be a resource for plans related to initial PPQ campaigns.    https://lnkd.in/ebA4iYKJ    #ATMP #celltherapy #genetherapy #validation

For more than 20 years, we’ve paired exceptional scientific integrity with the practical regulatory insights you need to successfully develop and market your #biotherapeutic. 🥼🧪 Whether you have an oncolytic virus, vaccine, gene therapy, immunotherapy, or other drug, our commitment to you is the same. Discover why #CustomBiologics is your trusted large molecule bioanalytical CRO: https://buff.ly/47pxJtb #bioanalysis #bioanalyticaltesting #CRO #cellbasedbioassay #bioassay #bioanalytical #lab #biologics

Social Pharma Patient-Centric Marketing socialpharma.net >>> Gene&Cell Therapy >> Metagenomi tinkers with pipeline after CSO departure, says Affini-T and Ionis pacts are progressing #lucidquest #genetherapy #celltherapy