West Jefferson, OH - AmplifyBio, a leading service provider in discovery, safety, and manufacturing services for the development of advanced therapies, has chosen Apprentice.io’s cutting-edge Tempo Manufacturing Execution System (MES) to expand production capabilities and meet the increasing demand for modern modality commercialization on shorter de-risked timelines. Apprentice’s, no-code, fully cloud-native MES is equipped with the power and flexibility necessary to drive the development of cell, gene, and mRNA therapies, giving AmpifyBio clients a critical tool to increase production efficiency while protecting the quality and data integrity of their products.
The Tempo MES further offers a novel configuration that integrates mobile tablets and voice-controlled wearable headsets and is a big step forward in integrating global teams to operate in real time. That seamless connection of remote teams makes the system ideal for AmplifyBio, which offers manufacturing services in varied staffing models that allow client development teams to be hands-on and fully integrate with AmplifyBio experts and support staff throughout manufacturing scale-up. Collaborating closely with the Apprentice professional services team, the AmplifyBio group achieved a swift implementation and validation of the Apprentice Tempo solution in a record-setting period of fewer than four months. This remarkable achievement equips AmplifyBio and its clientele with the capacity to effortlessly adapt to evolving processes while eliminating the necessity for extensive batch process re-engineering. Key features of this groundbreaking implementation include simultaneous access to process data from multiple locations and a streamlined data exchange system throughout the manufacturing process, enhancing operational efficiency and flexibility.
"AmplifyBio's decision to choose Apprentice's Manufacturing Execution System shows our commitment to introduce modern, flexible, and scalable manufacturing processes that accelerate end-to-end production and supercharge our data-centric journey," said Karim Khoury, VP of Information Systems at AmplifyBio. "As we rapidly increase our capacity to offer manufacturing suites in hoteling business models, hybrid team models, and full partnership models, it's critical to ensure that those novel approaches to staffing are paired with the right technology solutions and like-minded partners to uphold timelines and quality standards, and critically, much earlier in the development process than is typical."
Since its inception, AmplifyBio set a strategic mission to create a paperless, technology-integrated drug development environment offering fully customizable service programs. With the adoption of Apprentice’s Tempo MES, they are embracing modern manufacturing practices critical to accelerating the development of modern therapeutics for patients waiting for them.
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.
Apprentice helps life science manufacturers get therapeutics to patients faster by providing one platform to turn molecules into medicine. Our Tempo Manufacturing Cloud accelerates the end-to-end drug product lifecycle by connecting together distributed teams and sites, helping them execute better on the shop floor, and optimizing their operations through enterprise-wide visibility. From preclinical benchtop to large-scale commercial manufacturing, Tempo keeps your global teams connected, empowered, and in sync.
Learn how leading companies like Synthego and Bristol Myers Squibb are using Tempo to scale from drug discovery to patient delivery faster at www.apprentice.io.