Earlier this year Fujifilm Corporation acquired Biogen (Denmark) Manufacturing ApS, a large-scale biologics manufacturing site located in Hillerød near Copenhagen, Denmark from Biogen. Fujifilm invested approximately $890 million in the deal.

The Hillerød Manufacturing site is now the fourth biopharmaceutical manufacturing site of Fujifilm Diosynth Biotechnologies, a subsidiary of Fujifilm and a leading contract development and manufacturing organization (CDMO) with expertise in the development and manufacture of biologics and advanced therapies. Hillerød Manufacturing changed its name to Fujifilm Diosynth Biotechnologies Denmark ApS once all regulatory procedures were completed.

The new site consists of a campus hosting a large-scale production facility equipped with six 15,000L bioreactors for the manufacture of cell culture derived biologics for clinical and commercial use. There are close to 800 employees at the Hillerød campus, which also houses an assembly, labeling and packaging facility, quality control laboratories and warehouses. The products manufactured under Biogen at the site will continue to be supplied by Hillerød Manufacturing under Fujifilm ownership.

Contract Pharma caught up with Liza M. Rivera, vice president of global marketing for Fujifilm Diosynth Biotechnologies, to talk about the acquisition and what it means for the CDMO moving forward.

Contract Pharma (CP): How does the recent acquisition of Biogen’s Hillerød site enhance Fujifilm’s position in the CDMO space?

Liza Rivera (LR): Fujifilm’s culture of innovation and its reputation of manufacturing excellence provides unique value to the fast-growing bio CDMO industry where quality and experience may come at a premium.

Our acquisition of the Hillerød site in the European market demonstrates the clear focus of Fujifilm to deliver globally on its strategy, which is two-fold: one, increase cell culture capacity deliberately and significantly; and two, support projects from pre-clinical through to commercialization with best-in-class assets capable of delivering very-small to very-large production volumes.

Fujifilm Diosynth Biotechnologies, a subsidiary of Fujifilm Holdings Corporation, now has expertise in process development, in manufacture and in aseptic filling for its full service CDMO approach. We have reliable and tested capability for a variety of biologics including recombinant proteins, monoclonal antibodies, viral vaccines and gene therapies. 

CP: How would you characterize the state of the biopharma outsourcing market?

LR: The biopharma outsourcing market continues to be very strong. In the past year, CDMOs have continued to expand capacity and we have seen a large number of mergers and acquisitions, including our organization with the recent acquisition in Denmark. These are great indicators of a healthy market. 

CP: What are the major trends moving the market forward, and/or holding it back?

LR: The latest trend numbers in global demand for biopharmaceuticals that we have seen from Research and Markets says that growth last year was led by the market for monoclonal antibodies (mAb), estimated at $82.3 billion (33.2% share) in 2018, and projected to provide a fast compound annual growth rate of 10.8% between 2018 and 2025. The same study says that the global market for biopharmaceuticals this year is expected to reach $269.3 billion this year.

Global market growth is driven by several factors: aging populations, a diagnostic surge in identified chronic diseases like diabetes, the deconstruction and unlocking of once-fatal viral and cancer genomes, and expanding medical adoption of once-exotic biopharmaceuticals as appropriate if not preferred protocols for the cure and treatment of common disease and disabilities.

CP: Why bet on the bio-CDMO sector to grow the Fujifilm business?

LR: We are expanding our business with the goal of becoming a “total healthcare company” covering the areas of prevention, diagnosis, and treatment. In addition to investing in medical systems and life sciences, we view investing in bio-CDMO as crucial in order to improve the profitability of Fujifilm’s pharmaceutical and regenerative medicine businesses. 
Going forward, we will grow the healthcare business by improving the profitability of our pharmaceutical and regenerative medicine business while expanding our bio-CDMO business. 

CP: What are projections for new business growth from the recent acquisition?

LR: Fujifilm’s CDMO business is profitable. We have thoughtfully made capital investments and asset acquisitions in our bio-CDMO business. We intend to continue to promote growth along these lines by expanding the bio-CDMO business and we see it as the principal growth driver for the healthcare area. 

CP: How does the Hillerød acquisition increase production capabilities?

LR: Our decision to acquire the Hillerød assets was based on the ways the acquisition strengthens Fujifilm. It enhances our production capacity and human skills generally. It completes the full arc of our production capabilities, from small-scale operations and investigational drug development through to large-scale commercial production. 

Recent industry published research has shown that just as the number of drugs in development continue increase the number of yearly approvals is also expected as our industry matures and new classes of therapies such as biosimalrs move forward. Increasing our capacity through the Hillerød acquisition at this time sets us up very well to meet future demands.

CP: What do you predict for the future of large molecule development?

LR: In contrast, the growing number of current-day biopharmaceuticals are based on the production of large therapeutic protein molecules. These biologics are driving an expanding revolution in healthcare. They bind to specific cell receptors that are associated with the process and progress of terrible diseases—diseases that once went untreated or must be more brutally excised by surgery, chemical assaults, or radiation. With biologics, doctors can mark and fight specific abnormal cells with far fewer side effects than classic tactics like chemotherapies.

The development of new technologies have facilitated how we discover, develop and produce biotherapeutics. High throughput approaches to process and analytical development are speeding up the development of manufacturing processes, which in turn means that patients will be getting treatments made available faster. Manufacturing technologies will help the production processes become more efficient allowing for reduction of costs. 

When those biopharmaceutical systems are augmented with artificial intelligence systems, we will quite soon be capable of screening and testing tens of thousands of protein variations in a single day, in a single laboratory. We are seeing a near-time future where we can alter and edit the very blueprint of life and disassemble the diseases that diminish and destroy life. 

CP: What challenges do CDMOs in the biopharma industry face, and how is Fujifilm addressing these?

LR: Large pharma is pushing more work to CDMOs, but it is also pushing more clinical and financial risk their way.

There is legitimate concern that the current CDMO “land rush” puts management of some players into the hands of private equity firms that may have less tolerance for slow and deliberate action and high demands for a fast payback on the money they have invested.

When a company stumbles in pursuit of quality or next-step technology, company assets and talent may be too quickly abandoned as investors move on to the next good thing that beckons in global markets. 

Liza M. Rivera, vice president of global marketing at Fujifilm Diosynth Biotechnologies, is a marketing professional with experience in contract services including: process, formulation, analytical methods development, bulk drug substance manufacturing (cell culture and fermentation), stability studies, technology transfer and fill/finish. Her experience also includes freeze-thaw technologies and filtration systems. Liza has over 15 years of sales and relationship management experience in biopharma before transitioning into a marketing role.