Advancing the MAb Therapies of Tomorrow

Thomas Page (vice president, engineering and asset development, Fujifilm Diosynth Biotechnologies USA) 1:00–1:20 pm

Page introduced Fujifilm Diosynth’s Saturn monoclonal antibody (MAb) platform, which is based on the Apollo cell line. A senior team working from three facilities designed this new platform by challenging everything from previous designs, keeping the best aspects, and throwing out what did not work well — while innovating where necessary. All functional units were represented and empowered to make decisions. The team used risk-based tools to arrive at its design.

The Project Saturn mission statement is “to enhance FDB’s global capability by offering competitive MAb development and manufacturing capacity meeting regulatory standards and client needs for rapid and reliable clinical and commercial supply.” Through this project, the company offers its clients capability, capacity, and flexibility.

Page showed a video detailing the project. The video described FDB as a current good manufacturing practices (CGMP) contract development and manufacturing organization (CDMO) with sites in the United Kingdom, North Carolina, and Texas. The company supports its partners getting their products to clinic and ultimately commercialized with products, supplies, technologies, and expertise.

The Saturn MAb platform can take clients from early phases to the commercial stage. A Texas facility was modified to use this platform for CGMP MAb production. The site has 24,000 L of upstream capacity, and its production room is a multiproduct area designed to handle both clinical and commercial production. In a cell-expansion room, GE Healthcare’s Wave bioreactors with customized single-use bioreactor bags minimize contamination risk. All processing is fully closed. The harvest and capture room uses prepacked columns for early phase manufacturing and can replace those for commercial processes with larger chromatography systems or scale out using a second downstream train. Closed processing allows for robust segregation between downstream processing unit operations. A bulk formulation and filling room uses single-use tangential flow filtration (TFF), and the bulk filling system supports bags and bottles. To keep costs down, clients can choose among small, medium, and large downstream designs. Process analytical platform methods already have been developed. The Saturn platform at FDB’s Texas facility is designed with a robust process for reliability in manufacturing.

How It Works: Process development (PD) begins at FDB’s Wilton Center to translate a client’s process to the Saturn platform. Information then is transferred as a recipe from PD to manufacturing in Texas. Programs requiring more extensive PD can be brought in through existing UK and NC systems.

A closed process is desirable for preventing contaminations. “A truly closed process could run outside,” Page said. In facility design, closed processes enable ballrooms where multiple products can be manufactured in the same room at the same time. They use lower room classification than traditional processes, with simpler gowning and reduced environmental monitoring and cleaning. And they allow for rolling maintenance activities: A facility doesn’t have to shut down for maintenance. The modified facility in Texas is designed as an advanced, modified ballroom. There, FDB captures the greatest flexibility while optimizing risk control using such a design. The company will be performing a closed-process validation that will allow it to qualify as a verifiably closed operation.

Designed for robustness in manufacturing for a broad range of clients, the Saturn platform lowers variability in raw materials, consumables, and stock levels. It helps clients derisk their programs. Page calls it “the platform for life” — referring both to lifesaving therapeutics for patients and an optimized lifecycle of biopharmaceutical products.

Watch these full presentations online at www.bioprocessintl.com/BIO2017.