Minaris Advanced Therapies

We’re proud to share that Heather Malicki, Ph.D., Executive Director of Analytical Sciences at Minaris Advanced Testing, will be speaking at the upcoming Festival of Biologics . This can’t miss presentation, Potency Assay Technology Transfer Best Practice, will take place on Day 1 of the conference, September 30, at 3:00pm in the Cell Therapy Track. Dr. Malicki will explore how robust potency assay strategies are essential to the success of cell and gene therapies—covering key milestones in tech transfer, best practices, and real-world case studies from her 15+ years of experience. Don’t miss this opportunity to gain insights into advancing potency assays for clinical and commercial success. ##MinarisAdvancedTesting #FestivalofBiologics #MinarisAdvancedTherapies #AnalyticalTesting #Biosafety #mAbs #Biologics #GMP 

The 10th annual CAR-TCR Summit is taking place in just two weeks in Boston and Joseph Newcome, Senior Director of Analytical Development, will be speaking in the Analytical Development Track on Day 1 at 11:15 AM. Joe’s session entitled “Potency Assay Technology Transfer: Best Practices for Cell & Gene Therapies” will cover the following: - How to transfer potency assays for consistent quality & efficacy - Aligning assay development, validation & GMP requirements - Case studies highlighting successful transfer strategies Don’t miss this opportunity to learn about one of the most critical aspects of cell therapy development and manufacturing from an experienced and seasoned expert. Nithya Jesuraj, PhD and Francesca Vitelli will also be on site and ready to discuss how we can partner with you to help you advance your cell therapy. Message us to arrange a meeting in advance or stop by and connect with us at Booth #33. #CARTCRSummit #MinarisAdvancedTherapies #CellTherapy #GeneTherapy #PotencyAssays #TechTransfer #AnalyticalDevelopment

Get to know Minaris Advanced Testing! Part of Minaris Advanced Therapies, and now U.S. owned, our Advanced Testing business provides trusted GMP Analytical & Biosafety Testing for biologics and advanced therapies — from mAbs and vaccines to viral vectors and cell therapies. Minaris Advanced Testing offers a long history of excellence and innovation: - 40+ years of experience in analytical testing - 1,700+ assays developed across diverse modalities - 10,000+ samples processed annually - 27+ commercial programs supported - 140,000+ sq. ft. of dedicated testing laboratories in the Philadelphia Navy Yard Learn more about how Minaris Advanced Testing can support your programs by visiting https://lnkd.in/eUwdy5Jf to submit a request to connect with our experts today. #MinarisAdvancedTherapies #AnalyticalTesting #Biosafety #CellTherapy #GeneTherapy #Biologics #GMP #USOwned

On September 18th Xuemei Wan Associate Director MS&T will be delivering the Opening Address & Keynote Presentation titled "Accelerating the Journey from Development to Commercialization" at the Advanced Therapies Xchange – San Francisco. Bryan Hart and Stephen Wang will also be on site to participate in the roundtable discussions throughout the day and meet one-on-one with attendees. We’re excited to connect and explore how we can jointly accelerate the path from scientific innovation to real-world impact. Learn more and register here https://lnkd.in/eqxAyW-K #MinarisAdvancedTherapies #AdvancedTherapies #CGT #CellandGeneTherapies

Our Chief Commercial & Technology Officer, Eytan Abraham, will be joining an esteemed Industry Panel at the inaugural APAC Virtual Summit: Cell & Gene Therapy Horizons, hosted by the Alliance for Regenerative Medicine (ARM) on September 10, 2025, from 9:00 AM to 1:00 PM ET. Eytan will be joined by senior leaders across the industry, including leaders from @Healios NA, EpiBone, CTI Clinical Trial & Consulting, and Forge Biologics. Don’t miss this opportunity to gain insights and discuss strategies for advancing CGT access and innovation in APAC. See the full agenda and register via ARM’s site here https://lnkd.in/eYG7aVsN #APACLifeSciences #CellAndGeneTherapy #CGT #AdvancedTherapies #RegenerativeMedicine #Biotech #HealthcareInnovation 

We’re live at Advanced Therapies Europe in Barcelona this week! Our Minaris Advanced Therapies team — Simona Jusyte, Cristina I. Ureche, Ph.D. , Amy Stewart, and Rachael Adamson — is on site and ready to discuss your latest challenges and opportunities. If you’re here, let’s meet. Whether your focus is clinical translation, commercial scale-up, or robust product characterization, we’d love to discuss how our global expertise can help accelerate your programs. Message the team directly or reach out via the partnering portal to set up a time. #AdvancedTherapiesEurope #CGT #Biotech #MinarisAdvancedTherapies

We’re excited to welcome Shari Udoff-McDonald as Vice President, Global Sales and Business Development for the Minaris Advanced Testing business.    Shari brings more than 25 years of experience in leadership, sales, business development and marketing in support of biopharmaceutical, vaccine and government organizations and companies.  Prior to joining Minaris, Shari spent 17 years at BioReliance Corporation, part of MilliporeSigma, in various sales and leadership roles spanning parts of North America and Europe and was most recently with Scorpius BioManufacturing, a small-scale drug substance biologics CDMO as VP, Commercial Operations and Head of Government Affairs. Shari is well versed in working in the GMP contract testing market for a wide variety of programs including cell and gene therapies, biologics, viral vaccines, ADCs and more.  Please join us in welcoming Shari to the Minaris Advanced Therapies team!

Our team is looking forward to #BIoTechWeek in Boston this September. You can find our Global VP of Process, Analytical Development and Innovation, Francesca Vitelli on stage during Cell & Gene Therapy International. She is chairing the Gene Therapy Manufacturing & Analytics track and moderating a panel on “Starting with the End in Mind: Designing Smart for Successful Cell & Gene Therapy Development.” Nithya Jesuraj, PhD and Venus Wenxin Huang, Ph.D. are also attending and are ready to schedule discussions to explore how we can partner with you wherever you are on the journey from IND to BLA. Message us to arrange a time to meet!

Minaris Advanced Therapies was established in May to unite two CDMOs with decades of experience in cell and gene therapy manufacturing and a robust GMP testing organization that provides advanced testing services for mAbs and vaccines in addition to cell and gene therapies. With operations across the U.S., Europe and Asia, and partnerships with close to 200 biopharma companies worldwide, Minaris Advanced Therapies is positioned to help promising therapies with everything from process and analytical development to clinical manufacturing and global commercial supply. In a recent Philadelphia Business Journal feature, CEO Orla Cloak discussed our global capabilities, innovation in manufacturing, and the skilled talent needed to deliver transformative therapies to patients. Read more here https://bizj.us/1qo9zu #AdvancedTherapies #CellTherapy #GeneTherapy #Biologics #PhiladelphaBusinessJournal 

We’re excited to welcome Francesca Vitelli who has joined Minaris Advanced Therapies as Vice President, Global Head of Process, Analytical Development, and Innovation. Francesca is a veteran biotechnology leader with deep expertise in cell therapy and viral vector process development, manufacturing and innovation, and CMC strategy, with proven success in building engagement and high performing teams. Most recently she served as Vice President of Cell Therapy and AAV Process Development at Intellia Therapeutics. Over her career, Francesca has led global teams to advance Cell & Gene therapy solutions from innovation to clinical success. Her career spans senior roles in academia, biotech, and global CDMOs, with a relentless focus on patient access to CGTs.  Francesca holds a PhD in Medical Genetics from the Università di Siena and a BS in Biological and Biomedical Sciences from Georgetown University. Please join us in welcoming Francesca to the Minaris Advanced Therapies team!  #CellTherapy #CGT #ViralVector #Leadership #Biotechnology #MinarisAdvancedTherapies