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WEST JEFFERSON, Ohio, January 30, 2025 (Newswire.com)
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AmplifyBio, a leading preclinical CRO and CDMO played a pivotal role in shaping discussions at Phacilitate’s Advanced Therapy Week, held January 20-23 in Dallas, Texas. As usual, the event brought together global experts to discuss challenges and potential solutions to accelerate the commercialization of advanced therapies.
J. Kelly Ganjei, CEO of AmplifyBio, moderated a session titled “The CAR-T Story and the Future of Cell Therapies.” Joined by Dr. Bruce Levine from the University of Pennsylvania, Lana Shiu of Kite Pharma, Boro Dropulic of Caring Cross, and a cancer survivor who is receiving CAR-T therapies on an ongoing basis, the panel explored critical topics such as breakthroughs in CAR-T for solid tumor cancers, regulatory compliance, the challenges of long-term patient monitoring, cost control, and how to increase accessibility. Kelly led a robust conversation while inserting the lessons he has learned on the importance of advanced data solutions and keeping product characterization central to a commercialization strategy.
In addition to leading the discussion on CAR-T therapy, Kelly participated in a roundtable titled “Migrating GMP Manufacturing Facilities from Clinical to Commercial Compliance.” Alongside representatives from cGMPNow, CDMOs, and industry drug developers, the group addressed key differences between clinical and commercial compliance. The discussion highlighted the importance of facility design, robust contamination control strategies, and fostering a culture of problem-solving and accountability. Attendees gained valuable insights into navigating inspections and the significance of service providers committing to external reviews for continuous improvement.
AmplifyBio also hosted a dinner roundtable event to explore the “Hoteling” Model for Advanced Therapy Manufacturing. The session brought together drug developers to examine the benefits and challenges of hoteling and hybrid staffing models in CGT manufacturing, where clients can be on-site to collaborate directly with CDMO experts. AmplifyBio employees shared lessons learned from working in the CDMO industry on some of the first cell and gene therapy products to reach the clinic, underscoring the flexibility and communication improvements that could come from client and provider staff being more cohesive. There was broad consensus that while outsourcing is convenient and cost-effective, there are times when hoteling and hybrid staff strategies drive efficiency and scalability in advanced therapy manufacturing.
“We are committed to collaborating with the advanced therapy community to overcome challenges and create safer, more efficient paths to commercialization,” said J. Kelly Ganjei. “We always want to be where these critical conversations are happening so we can be more effective partners and ultimately improve patient outcomes.”
AmplifyBio’s presence extended to the exhibit floor, where the commercial team engaged with current and potential partners. The company highlighted its comprehensive discovery, safety, and manufacturing services designed to streamline the commercialization of cell therapies, gene therapies, mRNA therapies, and plasmid production.
For more information about AmplifyBio’s services and future engagements, visit www.amplify-bio.com.
About AmplifyBio
AmplifyBio is a preclinical CRO and CDMO organization founded on the principle that all development and scale-up of advanced modality drugs should be done with commercial and clinical goals in mind. AmplifyBio launched with an initial offering of industry-leading preclinical toxicology, safety, and efficacy testing in an agile environment with analytics capabilities that serve the dynamic safety requirements of modern modalities. Since then, they have developed drug characterization and optimization service capabilities and opened a GMP manufacturing facility to provide complete concept-to-commercial partnerships for commercializing advanced therapies.
Source: AmplifyBio
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