Minaris Advanced Therapies

We're excited to announce the opening of our new GMP manufacturing facility in Taufkirchen, Germany, strengthening Minaris’ global manufacturing network and reinforcing its position as a trusted partner in advancing cutting-edge therapies from concept to commercialization.   Located just minutes from Munich International Airport, the new facility enables the consolidation of process and analytical development, and all the legacy manufacturing operations onto a single site. It features six Grade B/A cleanrooms and one Grade C cleanroom designed for bioreactors and closed systems, as well as dedicated process development and quality control laboratories, cryopreservation and storage facilities, and more to meet client needs.   “The opening of this facility marks an important milestone in our mission to accelerate the development and manufacturing of transformative cell and gene therapies globally,” said Dr. Orla Cloak, CEO.   Learn more about how we're enhancing our European footprint: https://xmrrwallet.com/cmx.plnkd.in/exwSzjkb   #CellandgeneTherapy #CDMO #MinarisAdvancedTherapies Photo caption: Minaris Advanced Therapies Board, Executive Leadership and Site Leadership members celebrate the Taufkirchen facility ribbon cutting.

We are proud to welcome Luciana Mansolelli as our new Chief Quality Officer, completing our Executive Leadership Team and marking a major milestone in our strategic growth. Luciana brings over 29 years of leadership experience spanning development, manufacturing, quality, and corporate strategy.  As Chief Quality Officer at Minaris Advanced Therapies, she champions quality as a competitive advantage in advancing cell and gene therapies and expanding patient access through robust, compliant, and innovative systems. She is a recognized expert in advancing quality systems that support innovation and regulatory excellence in cell and gene therapy. With the recent addition of Luciana, Minaris Advanced Therapies now has a complete and dynamic executive leadership team marking a significant milestone in our company’s growth and strategic direction. Our Executive Leadership Team includes: ·      Orla Cloak, Ph.D. – Chief Executive Officer ·      Eytan Abraham, Ph.D. – Chief Commercial and Technology Officer ·      Hiroto Bando, Ph.D. – President, Japan ·      Kaia Boyd – Chief Human Resources Officer ·      Bill Burckardt – Chief Financial Officer ·      Rachel Collins Clarke – Chief Legal Officer and General Counsel ·      IIya Koltover, Ph.D. – Chief Transformation Officer ·      Luciana Mansolelli, PharmD – Chief Quality Officer ·      Prakash Manwani – Chief Information Officer ·      Darwin Richardson – Chief Operating Officer Iain Baird, Chairman of the Board, Minaris Advanced Therapies expressed, “I am delighted to present a passionate and experienced team that is united in our objective of transforming Cell Therapy manufacturing to enable our client’s commercial success.” Learn more about advancements from Minaris Advanced Therapies at www.minaris.com. #Cellandgenetherapy #Leadership #MinarisAdvancedTherapies #CDMO Photo from left to right: (Top) – Prakash Manwani, Bill Burckardt, Eytan Abraham, Orla Cloak, Darwin Richardson, Ilya Koltover; (Seated) – Luciana Mansolelli, Rachel Collins Clarke, Kaia Boyd; (Not pictured) Hiroto Bando.

🤝 Partnering at BIO Asia–Taiwan 2025 — Let’s Connect! Minaris Advanced Therapies is open for partnering meetings during: 🖥️ Virtual Partnering: July 22–23 🏢 Onsite Partnering: July 24–26 at Booth M309 (Taipei Nangang Exhibition Center) As a global CDMO in cell and gene therapies and a leading biopharma testing provider, we’re looking forward to exploring new collaborations that drive innovation in regenerative medicine. 🔗 Reach out via the official partnering platform to schedule a meeting with Emmanuelle Bommier, Business Development! #BIOAsiaTaiwan #Partnering #MinarisAdvancedTherapies #CDMO #CellTherapy #GeneTherapy #Taipei2025

Welcome New CEO, Dr. Orla Cloak   We are thrilled to announce that Dr. Orla Cloak has joined Minaris Advanced Therapies as our new CEO. With more than 20 years of global executive leadership, Orla brings deep scientific expertise and commercial insight. Her customer-centric mindset and track record of driving sustainable growth across the life sciences sector make her an exceptional fit for our future. As we pursue our mission to become the leading pure-play global cell therapy CDMO, Orla’s leadership will be key to accelerating innovation and delivering lasting impact. Please join us in warmly welcoming Orla to the Minaris team!   Read the full Press Release here: https://xmrrwallet.com/cmx.plnkd.in/eXA3x96G .   #Leadership #CellAndGeneTherapy #CDMO #MinarisAdvancedTherapies

🧫 We're Exhibiting at BIO Asia–Taiwan 2025! Minaris Advanced Therapies is excited to announce our participation in BIO Asia–Taiwan 2025, taking place from July 24–27 at the Taipei Nangang Exhibition Center. We would love to discuss with you our Global Cell, Gene and Testing CDMO services. 📍 Booth No.: M309 🕒 Exhibition Hours: ・July 24 (Thu) – July 26 (Sat): 10:00 AM – 6:00 PM ・July 27 (Sun): 10:00 AM – 5:00 PM We look forward to connecting with industry leaders, innovators, and partners in the Cell and Gene Therapy and biotech space. Please visit our booth or lets arrange a meeting, please contact us at: 📩 mrj_contact@rm.minaris.com 🎟️ Visitor registration is now open! Register here:  https://xmrrwallet.com/cmx.plnkd.in/dadXYXez See you in Taipei! #MinarisAdvancedTherapies #BIOAsiaTaiwan2025 #RegenerativeMedicine #CellTherapy #CDMO #BiotechInnovation #Healthcare #TaipeiEvents #MeetUsThere

We are excited that our Chief Technology Officer and Chief Commercial Officer, Dr. Eytan Abraham, will speak at the Outsourced Pharma Capacity Update, the Cell & Gene Therapy session this Thursday, July 17, 2025, at 10 a.m. As a recognized leader in advanced therapies, Dr. Abraham will discuss how Minaris expands capabilities and accelerates cell and gene therapy manufacturing innovation. This is an excellent opportunity to hear firsthand about the transformative advancements we’re driving, from cutting-edge technologies to enhanced capacity solutions designed to meet today’s growing industry demands. Join us and connect with our team at the event! We look forward to meaningful conversations, new partnerships, and helping shape the future of cell and gene therapy together. #MinarisAdvancedTherapies #CellandGeneTherapy #CDMO 

Last night we hosted the 5th event this year in the new #BioInnovation Series created by BioBuzz - Greater Philadelphia entitled "Beyond the Breakthrough: Manufacturing Cell and Gene Therapies at Scale." The event was sold out! It was a huge honor to welcome more than 100 of our fellow professionals and members of the #Philadelphia ecosystem to our headquarters in the #NavyYard. The night commenced with the BioBuzz Awards and a very inspiring, motivating, and personal patient impact story from Mary Genevieve Carty which served to remind us all why we do the work we do and how dependent patients and their families are on the outcomes. Next, there were two panel discussions centered on the journey from clinical to commercial manufacturing and the nuances of that journey. Panel #1 was moderated by patient advocate Brad Watts who posed both challenging and strategic questions to Arvind Natarajan, PhD SVP Process & Analytical Development, Iovance Biotherapeutics, Inc., Sarah Yuan, PhD, CTO at Cabaletta Bio and Rick Lehman, Interim Site Head of Quality at Minaris Advanced Therapies. Panel #2  was led by Daniel Collier, Director of Clinical Manufacturing at Minaris Advanced Therapies who has taken many clients on this journey in his career and had the opportunity to elicit insights and best practices from Karen Arneson, Director of External Manufacturing at Spark Therapeutics, Inc., Cheryl Custard, MSc, Director & Business Owner, US Quality Systems & GMP Training at Adaptimmune and Raymond Luke Senior Director of MSAT at Verismo Therapeutics. After the panels concluded attendees took advantage of the opportunity to join Audrey Chang and Andreas C. Solomos, Ph.D. for tours of our dedicated biosafety and characterization testing laboratories. Finally, a good number of people joined us at the Marriott Courtyard to continue networking and discussions. Huge kudos to Bryan Kennedy of BioBuzz for orchestrating the evening’s activities and keeping us all on track for what was a packed agenda! We are grateful to have the opportunity to sponsor this year’s BioInnovation Series and look forward to the remaining events and thank everyone who came out in the heat to join us last night. Message us if you missed the opportunity to attend or want to learn more about how we work with our clients to help them "Beyond the Breakthrough."

We are proud to announce we have recently welcomed three accomplished leaders to our executive team. Effective May 19, 2025, Kaia Boyd, SHRM-SCP joined as Chief Human Resources Officer, Rachel Collins Clarke as Chief Legal Officer and General Counsel, and Ilya Koltover as Chief Transformation Officer. Kaia brings deep expertise in HR leadership across CDMOs, most recently at Societal CDMO and Ajinomoto Bio-Pharma Services. Rachel is a seasoned legal executive with a strong background in cell and gene therapy from Spark Therapeutics, Adaptimmune, and private practice. Ilya, an experienced commercial and operations leader, joins us from Solvias and brings a strong track record in organizational transformation across the life sciences sector. Read the full announcement https://xmrrwallet.com/cmx.plnkd.in/eQfeQram and please join us as we welcome Ilya, Kaia, and Rachel to the team!

The team from Minaris Advanced Therapies was excited to join dozens of other cell and gene therapy professionals today at the Advanced Therapies hubXchange in Boston! 👩🔬 Heather Malicki, Ph.D., Executive Director of Analytical Development delivered a spotlight presentation on one of the most critical — and complex — aspects of CGT manufacturing: potency assays. Potency assays are an essential measure that directly impacting drug dose, quality, stability, and clinical efficacy. For CGTs, there’s no one-size-fits-all method — each product demands a customized approach. Heather shared insights on: ✅ The difference between biosafety and potency assays ✅ Best practices for developing and validating potency assays ✅ Critical success factors for technology transfer ✅ Real-world case studies from our GMP experience As a global CDMO exclusively focused on cell and gene therapies, we know that robust analytical development and seamless tech transfer are key to moving therapies from bench to bedside. Message us at any time for a consult on your potency assays. #AdvancedTherapies #CellAndGeneTherapy #CDMO #PotencyAssays #TechTransfer #GMP #CGT #ATMP #Biologics #MinarisAdvancedTherapies #HubXchange2025

Members of our team including Joseph Newcome, Venus Wenxin Huang, Ph.D. and our summer intern Paige Tang joined the Immunotherapies Xchange in Boston this past Tuesday and enjoyed the opportunity to take lead on two sessions while also connecting one-on-one with innovators across the immunotherapy space. The first session was an interactive roundtable on Ensuring Biosafety in Next-Generation Immunotherapies and the discussion covered: • Best practices for biosafety assessment • Regulatory expectations for immunotherapeutic products • Risk mitigation during manufacturing and clinical application A key highlight was the open discussion around the latest FDA updates, sparking thoughtful dialogue on how evolving guidance impacts real-world development strategies. Shortly after lunch, Joseph Newcome gave a spotlight presentation on Potency Assay Tech Transfer Best Practices which shared key learnings from the successful transfer of many potency assays tailored for complex cell and gene therapies. Starting from development through GMP validation, the presentation outlined key milestones, lessons learned, and case studies that demonstrate how successful tech transfer enables clinical timelines and commercial readiness. Thank you to everyone who joined our sessions and made time to connect. Events like this fuel the collaborative spirit driving the future of advanced therapies! #CellTherapy #Immunotherapy #PotencyAssays #TechTransfer #Biosafety #FDAUpdates #CGT #CDMO #MinarisAdvancedTherapies #ImmunotherapiesXchange2025