Manufacturing Technology

Atara Biotherapeutics and Fujifilm Form Strategic Manufacturing Partnership

Atara Biotherapeutics and Fujifilm
On January 26, Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell immunotherapy, announced that it has entered into a long-term strategic agreement with FUJIFILM Diosynth Biotechnologies (FDB), a subsidiary of FUJIFILM Corporation (Fujifilm), under which Fujifilm will acquire Atara's T-Cell Operations and Manufacturing (ATOM).

A long-term supply agreement, possibly lasting ten years, will also be signed by the parties. Following the completion of the transaction, FDB, a leading contract development, and manufacturing organization (CDMO) focused on advanced therapies, will provide Atara with access to the flexible capacity and specialized capability necessary to manufacture clinical-and commercial-stage allogeneic cell therapies for its maturing and promising pipeline, including tabelecleucel (tab-cel®), which is currently undergoing regulatory review in Europe for EBV+ PTLD, ATA188 for multiple sclerosis, and allogeneic CAR T. Additionally, FDB will increase its reliance on the Thousand Oaks facility and harness its experienced workforce to manufacture a broader array of cell therapies. Atara will retain its manufacturing process science expertise, personnel, and capabilities to continue developing the initial manufacturing and scale-up of allogeneic cell treatments.

"FUJIFILM Diosynth Biotechnologies is a highly respected, quality-focused, industry-leading manufacturing and development organization that shares our pioneering culture and belief that allogeneic cell therapies will transform the future of medicine, We are incredibly proud of our world-class ATOM staff and facility and believe that this strategic partnership will meet our long-term manufacturing needs. Our team has developed processes for our products, scaled them up, and built inventory for clinical trials and the potential commercial launch of tab-cel. We believe that now is the right time for a strategic relationship with FDB to provide us with expert manufacturing capabilities, as needed. Accordingly, we will further focus our capital resources on the development and commercialization of our pipeline of potentially transformative therapeutics for serious diseases."

-Pascal Touchon, President and CEO of Atara.

Atara anticipates having $371.1 million in cash, cash equivalents, and short-term investments as of December 31, 2021. This information is preliminary, has not been audited, and is subject to change upon the company's financial statements for the year ending December 31, 2021, being audited.

Atara will get USD 100 million upon closing, and Fujifilm intends to hire roughly 140 highly experienced manufacturing and quality personnel at the facility. In addition, the arrangement is projected to result in a multi-year reduction in Atara's planned operating expenses. Following the transaction's close, the upfront consideration, combined with the decrease in operating expenses, is expected to fund Atara's planned operations through Q4 2023, beyond the anticipated completion of the randomized, placebo-controlled Phase 2 study of ATA188, the company's investigational off-the-shelf T-cell candidate with the potential to reverse disability in progressive multiple sclerosis.

Atara retains the recently established Atara Research Center (ARC) in Thousand Oaks, California. The ARC is fully operational and will house Atara's Pre-Clinical, Translational Sciences, Manufacturing Process Sciences, and Analytical Development teams, enabling the company to accelerate innovation by using the company's unique and differentiated allogeneic cell therapy platform. Additionally, Atara will retain a competent technical operations staff to manage external production, quality, logistics, and supply chain management.

"We are thrilled that through this acquisition, we will add approximately 140 talented staff from Atara’s cell therapy manufacturing facility to the FUJIFILM Diosynth Biotechnologies family. The collective expertise of the team will further support our efforts as a world-class CDMO, We also look forward to adding the facility to FUJIFILM Diosynth Biotechnologies’ existing global footprint and to bolstering the expansion of our advanced therapies CDMO business."

-Martin Meeson, chief executive officer, FUJIFILM Diosynth Biotechnologies

ATOM is a 90,000-square-foot state-of-the-art T-cell therapy manufacturing facility that is fully qualified to support clinical and commercial production and is built to scale to meet various production requirements and capacities. The transaction is scheduled to close in April 2022, subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other standard closing conditions.

Atara is advised by Evercore Group LLC on a strategic level and by Gibson Dunn & Crutcher LLP on a legal one.

*This press release contains or may contain "forward-looking statements," as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.



Related News

Manufacturing Technology

Gotion High-tech Chooses Siemens to Build New Manufacturing Platform

Siemens | September 15, 2023

Gotion High-tech chose Siemens Xcelerator industrial software to establish an intelligent battery production platform. Gotion High-tech will strengthen its intelligent battery manufacturing capabilities through a platform that integrates production process to expedite the development of digital products. Together, the companies aim to use digital twins and battery-specific digital threads in digital transformation. Siemens Digital Industries Software has announced that Gotion High-tech has chosen Siemens Xcelerator industry software to establish an intelligent battery manufacturing platform as part of its digital transformation efforts. As part of the collaboration, Gotion High-tech and Siemens plan to explore the application of digital twins and battery-specific digital threads in product research and development, production, manufacturing, and technical services. The goal is to enhance operational capabilities across its global factories through digital intelligence. Chairman of Gotion, Li Zhen, remarked, The cooperation between Siemens and Gotion High-tech aims to enhance the operational capabilities of global factories through the joint creation of Gotion's digital Intelligence plant. [Source:] He stated that the new era is about material digitization and transformation. As a company with a strong sense of mission and responsibility, Gotion High-tech is building an energy science system based on digital science and materials science. By integrating digital technology into the process of material research and development, product operation and battery recycling, production and manufacturing, the company hopes to achieve its goal of green energy accessible and sustainable, for the future. Gotion High-tech is looking forward to integrate digital technology into its entire material research and the entire development process, manufacturing, product operation, and battery recycling efforts. This integration aligns with their mission to establish an energy science system based on materials science and digital science, promoting green energy accessibility and sustainability. The company intends to leverage AI-enabled industrial control system technology to create a closed-loop digital research and development, manufacturing, and management platform. This platform will enhance Gotion's intelligent battery manufacturing capabilities and facilitate future digital advancements. Siemens Digital Industries Software specializes in aiding organizations in their digital transformation journey using software, hardware, and services from the Siemens Xcelerator business platform. Its comprehensive digital twin technology enables companies to optimize design, engineering, and manufacturing processes for sustainable product development.

Read More

3D Printing

BizLink counts on Rapid Prototyping with the help of 3D printing technology

PR Newswire | November 03, 2023

BizLink, a leading provider of connectivity solutions worldwide, uses a method for creating physical prototypes with computer-aided design (CAD) data. This so called 'Rapid Prototyping' enables development times to be shortened, costs to be lowered and innovative ideas to be realised more quickly. BizLink's Automation & Drives business unit will showcase one of these solutions at the sps trade fair in Nuremberg, Southern Germany, which takes place from 14 to 16 November. In the development and production of individual injection moulded parts, a large part of the cost and time is spent on providing the appropriate tools. That is why BizLink uses Rapid Prototyping for sample parts in the development phase of overmoulded connection components. The principal objective of this technology involves testing and validating design concepts, functionality and features before there is any investment in series production. Through Rapid Prototyping, BizLink thus reduces development costs and time-to-market for overmoulded components and its reinforced innovative cable systems for factory automation. Rapid Prototyping involves applying layer upon layer of materials or bonding them to one another with 3D printing to make the desired object. This makes it possible to quickly adapt the design as changes can easily be made in the CAD data and the prototype can then be reprinted. It also allows, for example, the spatial conditions during fitting and operation under real-life conditions to be assessed, letting the findings thereby acquired be incorporated in product improvement before a tool-maker has even started his or her job. 3D printing technology can furthermore make valuable contributions to quality assurance while development is ongoing. If, for instance, parts being tested must be scrutinised to limit failure mechanisms along functional boundaries, it helps to be able to quickly create a matching testing device for such investigations. In some cases, such devices also facilitate good reproducibility, meaning that dependable component qualifications can also be carried out in this way. Other applications involve trialling numerous production resources and tools as well as handling aids that are, with respect to their function and ergonomics, initially tested as a 3D-printed specimen and improved repeatedly so that they can later be reproduced in a more robust version made of metal, for example. Rapid prototyping is versatile and has long been a proven tool for BizLink in the innovation process to bring new products to market faster and more effectively. Visitors to sps can convince themselves of these advantages through application examples in the Nuremberg exhibition halls from November 14 to 16, 2023 in Hall 2, Stand 431.

Read More

Industrial 4.0

ACL Digital with Tidal Wave to Drive Industry 4.0 Transformation

ACL Digital | October 09, 2023

•The agreement will integrate both organizations' key expertise to create private 5G solutions with lightning-fast speeds, URLLC, and mMTC. •The alliance is committed to providing personalized 5G solutions for manufacturing, healthcare, automotive, and other industries. •With operations on different continents, the joint offerings will benefit businesses worldwide, assuring local regulatory compliance and regional adaptation. •The cooperation provides advanced 5G infrastructure, consultancy, deployment, maintenance, and continual upgrades. ACL Digital and Tidal Wave have joined forces to establish a private 5G alliance aimed at advancing Industry 4.0 transformations. The partnership seeks to empower businesses with cutting-edge private 5G technology, enhancing operations and productivity across telecom and enterprise verticals. This alliance leverages ACL Digital's digital transformation and system integration expertise with Tidal Wave's private 5G knowledge to offer tailored solutions for connected factories, smart ports, industrial automation, and more. The collaboration will focus on delivering solutions for connected factories and warehouses, smart ports, smart manufacturing, industrial automation, real-time asset tracking remote monitoring and control. This partnership will extend to every region of the world, ensuring local compliance with regulations and allowing for regional adaptation. Its goal is to ensure compatibility and confident deployment of private 5G systems while delivering comprehensive engineering solutions and client support. Ramandeep Singh, CEO of ACL Digital, remarked that through their collaboration with Tidal Wave, they were initiating a journey into the changing realm of private 5G. He noted that the combination of ACL Digital's system integration capabilities and Tidal Wave's expertise would mark the beginning of a fresh phase in network transformation for their clients. Ramandeep highlighted that this alliance positioned them to lead global digital transformation initiatives, leveraging the significant potential of 5G to enhance various industries by adopting private networks. He added that this partnership would empower customers to improve their operations and productivity using the latest 5G technologies. Ankit Dixit, CEO of Tidal Wave, conveyed that in ACL Digital, they had found a partner who not only shared their forward-looking vision and practical approach to an interconnected industrial future but also effectively complemented their strengths. He mentioned that this collaboration established a new standard for innovative product offerings and a robust framework for execution and support. Ankit emphasized that the intricate customization required for implementing private 5G networks called for seamless cooperation between their two organizations, and he noted that this partnership operated exceptionally well between both entities.

Read More