CTI Clinical Trial and Consulting Services’ Post

#QuadplexdPCR as a tool to analyze #genomeintegrity and heterogeneity in gene therapy drug products The rapid growth of the #genetherapy field necessitates product-specific analytics, as critical quality attributes do not consistently correlate with drug potency or safety. It is hypothesized that the heterogeneity of packaged genomes contributes to this inconsistency. Next month, Ryan Massopust (Scientist II, Analytical Development, Asklepios BioPharmaceutical, Inc. (AskBio)) will explore a quadplex digital PCR (#dPCR) assay, employing four primer probe sets that span the genome from promoter to poly(A) signal sequence, that was developed to investigate this hypothesis. Register for this upcoming #webinar below:

Thoughts on this? >> Automation, decentralization and the future of CAR-Ts: Advancements in cell & gene therapy manufacturing (Part III) - FiercePharma >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #healthcare #pharma #biotech #pharmaceutical #competitivemarketing

Knut is one of the strongest leaders in cell and gene therapy with whom I've ever worked. If you want to cut through the complexity and find the simple, compliant and expedient path to success in the cell and gene therapy field, Knut is the best.

ATMPs are exciting therapeutic modalities that showcase how far science and technology have come. Getting these therapies from the lab to clinical trials and eventually to broader patient populations isn't easy though - there are quite a few hurdles to overcome. We're talking about complex products that need careful control strategies, thorough characterization, coordination with external partners (CDMOs, CROs), and navigation of an evolving regulatory landscape. I'm looking forward to presenting a webinar - "From Bench to Clinic: Decoding the IND Roadmap for Innovative Cell and Gene Therapies." The goal is to provide a clear, strategic overview of what it takes to go from research to IND, hopefully making this journey easier to navigate for complicated CGT products. Free Registration: https://bit.ly/3BcbDiH Thank you to Scientist.com for organizing this opportunity. #CellAndGeneTherapy #ATMP #CMC #Regulatory #DrugDevelopment #IND

Let us help you to optimize your AAV production efficacy with advanced aggregation analysis using TEM. #AAV #TEM #aggregation #QuTEM

Tuesday, January 23, 12-2pm ET: Join us for an informative seminar detailing #regulatory considerations and updated guidelines regarding the #development and #commercialization of cell and gene therapies. This seminar will feature Mantej (Nimi) Chhina, PhD, JD, Executive Director and Head of Global R&D and Regulatory Policy at BioMarin Pharmaceutical Inc. Dr. Chhina will focus on key details surrounding: -Unique regulatory considerations for cell and gene therapy product development -Developing and informing a regulatory strategy for your project -Q&A Attendees will have the opportunity to sign-up for a 1:1 meeting to discuss their project directly with Dr. Chhina. You must register via the link below and complete the meeting request form within the Eventbrite page description in advance. Meetings will take place directly after the program. You will receive an invitation with the suggested timeslot once Dr. Chhina has reviewed all submissions.   This event is hybrid and will take place at Weill Cornell Medicine BioVenture eLab (1157 York Ave) for in-person attendees. RSVP: https://lnkd.in/eMHE8U4M Loren A. Busby, CFA Qian Hua Ge Center for Technology Licensing at Cornell University (CTL) #cellandgenetherapy #productdevelopment #researchanddevelopment #regulatorystrategy

Alliance for Regenerative Medicine has released the newest sector snapshot. The cell and gene therapy sector go-to for all the statistics from our sector. Includes an update 2024 clinical pipeline, financing, industry trends and clinical trial landscape. 2,762 developers, 1,920 clinical trials and $11.7B in investment. #celltherapy #genetherapy #regenerativemedicine #advancdtherapies #cellandgenetherapy Tim Hunt Rita Johnson-Greene, MBA #geneediting #CARt #therapies #therapeutics #sectorupdate #biotech #biotechnology #healthcare #lifesciences #engineeredcelltherapies #Pharma #pharmaceuticals #regulatorypipeline #approvals #financing #clinicaltrials #investment #drugdevelopment #clinicalpipeline #cellengineering

I look forward to a productive, insightful discussion with Dr. Peter Marks

Optimize Production Efficacy with Advanced Aggregation Analysis Using TEM  At QuTEM (formerly Vironova BioAnalytics), we provide cutting-edge analytical tools for monitoring particle clusters and aggregates in your samples over time. By leveraging Transmission Electron Microscopy (TEM), we offer precise quantification of individual particles and aggregates, expressed either by total particle count or as a percentage ratio of the sample. This detailed analysis is vital for enhancing the stability and efficacy of virus-based vaccines and gene therapy products. Our expertise in nanoparticle TEM (nsTEM) enables us to visually and quantitatively assess aggregation—a key factor in product performance. Our team employs proprietary software for semi-automated detection and classification of viral particles and aggregates in TEM images. This approach delivers robust, quantitative insights into particle aggregation, supporting the optimization of your biopharmaceutical production processes. Contact us today and learn more about aggregation analysis! #AAV #TEM #QuTEM #aggregation #technology

🧬 Addressing channel strategy to improve patient access Melissa Lattanzi, VP of Emerging Therapies at Cencora, spoke to Pharmaceutical Executive about the unique challenges cell and gene therapy (CGT) developers face when building their channel strategy. To lay the foundation for effective commercialization, developers must understand where and how patients are treated – whether by community physicians, local hospitals or specialists – as well as clinical requirements and logistical challenges, such as storage capabilities. Delivery of CGTs involves addressing these logistical challenges by streamlining processes and automating workflows to enhance scalability – to improve patient access to potentially life-changing therapies. Read more ➡️ https://lnkd.in/eDe3tfsV #ManufacturingBrighterFutures #AutomateBetterBiology #AccelerateProductDevelopment #ScaleYourImpact