NEW ALBANY, Ohio, November 28, 2023 (Newswire.com) - AmplifyBio, a leading contract research organization, is announcing the opening of a new business unit to further expand its reach into the manufacturing of next-generation therapies that include cell, gene, mRNA, and other advanced modalities. The Amplify Manufacturing Enablement Center (AMEC), located 30 minutes from their West Jefferson headquarters in New Albany, Ohio, will comprise individual manufacturing suites, central laboratories, and office spaces available to clients in varied contract models. The staffing options range from a hoteling lease of the GMP space, where you bring your manufacturing team, to a highly collaborative and adaptable version of a traditional CDMO relationship. Between those options is a hybrid staffing model that allows clients to have their researchers on-site and hands-on in their process and product development, with the partnership of AmplifyBio technicians and expertise.
These innovative hybrid outsourcing options come at a time when the drug development industry is facing capital constraints and is eager for alternatives to challenging buy vs. build options. Integrating with AmplifyBio staff offers cost- and time-saving advantages by allowing drug developers to avoid heavy up-front investment in expertise and facilities while still allowing them to maintain control over intellectual property critical decision points and ultimately streamline technology transfer and operational readiness.
Phase 1 of the 350,000-square-foot manufacturing facility will open in the first quarter of 2024. It will include standalone B- and C-grade suites that can be configured to accommodate any modality and simultaneously produce multiple lots. The manufacturing suites are complemented by quality, process development, and expansive analytics laboratories staffed by experts at AmplifyBio to ensure that clients have access to a development "sandbox" of assay platforms, technologies, and expertise anchored in experienced GMP quality assurance and facility management.
AmplifyBio continues to drive toward a vision where early R&D and preclinical safety and efficacy assessments stay connected to process development and the chemistry, manufacturing, and controls (CMC) activities in early-stage manufacturing. Sophisticated data tools and paperless IT technologies are a crucial part of that. AMEC will open with fully enabled systems to integrate global teams, empowering data-driven decision-making, and safety assessments in real time. Those include paperless management systems for quality, assets, LIMS, environmental monitoring, and Apprentice.io Tempo Manufacturing Execution System (MES).
"At AmplifyBio, every capability we have added has been focused on closing the gap between early R&D and CMC. We want our clients to have rich characterization benchmarks set early in discovery and to stay attached to the product safety and scale up through CMC and manufacturing," said J. Kelly Ganjei, CEO. "The addition of a manufacturing facility is a logical next step for us to take in that pursuit. We can now truly offer an end-to-end technology-empowered journey to commercialization for a wide variety of advanced therapies that will continue to change more and more lives as the industry expands its reach into different indications."
Adding a Manufacturing Enablement Center is a critical step in AmplifyBio's mission to create a technology- and expertise-infused ecosystem for commercializing safer, more well-characterized advanced therapies. The site is added to an R&D outsourcing facility and a leading preclinical CRO to create a fully integrated development pathway.
About AmplifyBio:
AmplifyBio is a drug development and commercialization partner for advanced therapies. Launched out of Battelle in 2021, they provide industry-leading preclinical toxicology, safety, and pharmacology testing in an agile environment with analytics capabilities that serve the dynamic safety requirements of modern modalities. AmplifyBio further expanded in 2022 to offer R&D services with a particular focus on drug characterization services that de-risk scale-up and manufacturing. In 2023, they opened their first fully customizable manufacturing suites for lease in staffing models that range from full “hoteling” to more traditional outsourcing partnerships. In any service program, AmplifyBio clients harness decades of experience in drug development, safety testing, and manufacturing support services to reduce risks, timelines, and costs of bringing life-saving cures to patients.
Source: AmplifyBio
Share: