AmplifyBio Adds Innovative Laboratory & Manufacturing Outsourcing Solution

AmplifyBio, a contract research organization with laboratory and manufacturing operations in New Albany, will hold a grand opening January 25 for its new Amplify Manufacturing Enablement Center (AMEC) that will expand the production of next-generation therapies. Phase one of the center, a 350,000-square-foot manufacturing facility for cell, gene, mRNA, and other advanced modalities, comprises individual manufacturing suites, central laboratories, and office spaces. “We can now truly offer an end-to-end, technology-empowered journey to commercialization for a wide variety of advanced therapies, said J. Kelly Ganjei, CEO.

In 2022, the company announced it would invest approximately $150 million in a 350,000-square-foot facility here in response to rapid advances in drug discovery and delivery together with ever-evolving technologies driving unprecedented growth in the sector.

AmplifyBio’s new hybrid outsourcing options come at a time when the drug development industry is facing capital constraints and is eager for alternative opportunities. Integrating with AmplifyBio staff offers cost- and time-saving advantages by allowing drug developers to avoid heavy upfront investment in expertise and facilities, while allowing them to maintain control over intellectual property, critical decision points, and, ultimately, streamline technology transfer and operational readiness.

AMEC will open with fully enabled systems to integrate global teams to empower data-driven decision-making and safety assessments in real time. The Good Manufacturing Practice (GMP) space adheres to U.S. Food and Drug Administration regulations, enabling manufacturing teams to work in a highly collaborative and adaptable version of the traditional Contract Development and Manufacturing Organization (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 in partnership with AmplifyBio technicians and expertise.

The manufacturing suites are complemented by quality, process development, and expansive analytics laboratories staffed by AmplifyBio experts 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.