Significant Expansion of Production Facilities For Biopharmaceuticals in Denmark

Significant expansion of production facilities for biopharmaceuticals in Denmark
Accelerate expansion of outsourced biopharmaceutical development and manufacturing business with large investment of 100 billion yen

Doubled the production capacity of the drug substance, and established a contracted system that allows one-site, one-stop support from the drug substance to formulation and packaging

FUJIFILM Corporation (President: Kenji Sukeno ) will be the Danish base of FUJIFILM Diosynth Biotechnologies (FDB), which is the core company of biopharmaceutical CDMO *2 , in order to accelerate the expansion of contracted development and manufacturing business of biopharmaceuticals *1. We will make a large capital investment of about 100 billion yen. This investment will significantly expand biopharmaceutical manufacturing facilities, including the addition of drug substance manufacturing facilities and the establishment of new drug product manufacturing lines. FUJIFILM will sequentially operate the increased manufacturing facilities from 2022 to 2023 to double the production capacity of biopharmaceutical drug substances at the Danish site, and at the same site, one-site/one-stop from drug substance to drug product/packaging. We will build a system for outsourced manufacturing.

FUJIFILM is actively investing in FDB’s three bases in the United States (North Carolina, Texas) and the United Kingdom (Billingham) to increase biopharmaceutical production capacity and develop highly efficient and highly productive technologies We are working to expand the business of contracting the development and manufacturing of biopharmaceuticals. In August 2019, we acquired a manufacturing subsidiary of Biogen Inc., a major biopharmaceutical company, for approximately ¥98 billion, which has mass production facilities such as six 20,000-liter animal cell culture tanks and excellent human resources. It has started as the fourth base of FDB (base in Denmark). Currently, by combining FDB’s advanced manufacturing infrastructure and abundant manufacturing experience with FDB’s technology for stably providing high-quality pharmaceuticals, new drug manufacturing contracts from new and existing customers, new model manufacturing We have also received contract manufacturing of therapeutic drugs from the Coronavirus Infection Treatment Promotion Project *3 , and we are rapidly expanding orders.

This time, FUJIFILM will invest approximately 100 billion yen at the Danish site to significantly increase the production facilities for biopharmaceuticals in order to respond to the increasing number of orders and the growing needs for outsourcing.
First, in order to double the production capacity of drug substances in Denmark, we will expand the drug substance manufacturing line and add six tanks of the same size as the existing animal cell culture tanks. As a result, the Danish site will have 12 20,000-liter animal cell culture tanks, making it one of the few large-scale drug substance manufacturing sites in the CDMO industry and also in the biopharmaceutical industry.
We also constructed a new building and established a large-scale pharmaceutical production line for the first time in Denmark to support formulation. By adopting a state-of-the-art fully automatic formulation manufacturing system capable of filling about 35 million bottles/year, we are able to accept large-scale contracts. In addition, we have introduced a device that can assemble syringes filled with chemicals into a wide variety of auto-injectors *4 and a highly versatile automatic labeling/packing facility on the packaging line to meet a wide range of customer needs. I will continue.
Through these capital investments, FUJIFILM will build a system for mass production of biopharmaceuticals from drug substance to formulation/packaging with one-site/one-stop at the base in Denmark to further improve customer convenience. We will strive for further business growth.

FUJIFILM has developed a production process for all types of biopharmaceuticals such as antibody drugs, hormone preparations, gene therapy drugs, and vaccines, and takes advantage of its strength to handle manufacturing contracts from low-volume production to high-volume production, from API to formulation/packaging. We will achieve the sales target of 100 billion yen for FY2021 set in the bio CDMO business *5 . In addition, we are aiming for sales of more than 200 billion yen by fiscal 2025, in addition to the effect of increased revenue from this capital investment. We will continue to contribute to the further development of the pharmaceutical industry through the stable supply of high-quality pharmaceuticals.

*1 Drugs that utilize biomolecules such as proteins that have effects that cannot be achieved with low-molecular-weight drugs. In addition to insulin and growth hormone, vaccines, antibody drugs, gene therapy drugs, etc. are included.
*2 Abbreviation for Contract Development & Manufacturing Organization. We provide pharmaceutical companies with a wide range of services from cell line development in the early stages of drug development to production process development, stability testing, drug development and manufacturing, and over-the-counter drug manufacturing.
*3 The COVID-19 Therapeutics Accelerator, a treatment promotion project for the new coronavirus infectious disease (COVID-19), launched by the Bill & Melinda Gates Foundation with the Welcome Foundation and Mastercard. This project supports rapid development and manufacturing of therapeutic agents for COVID-19.
*4 An automatic injector, which is a formulation (or dosage form) into which a drug solution can be injected by pressing the injection button or pressing it against the skin.
*5 Including not only biopharmaceuticals, but also contract development and manufacturing of low-molecular drugs.

[Outline of capital investment]

1. Base

FUJIFILM Diosynth Biotechnologies Denmark
ApS (currently “Biogen (Denmark) Manufacturing ApS”, the company name will be changed to “FUJIFILM Diosynth Biotechnologies Denmark ApS” after notification to the regulatory authorities in each country)

2. Location

Hilrod City, Denmark

3. Total investment amount

About 100 billion yen

4. Contents of investment

[Pharmaceutical drug production line]
-Expansion of existing building-
Introduction of 20,000-liter animal cell culture tank (6 units)[Formulation manufacturing line]
-Construction of new building-
Introduction of fully automatic drug manufacturing system[Packaging line]
Introduction of equipment capable of assembling various types of syringe devices, automatic labeling and packaging equipment, etc.

5. Start time

June 2020

7. Operation period

API manufacturing line: Fall 2023
Formulation manufacturing line: Summer 2023
Packaging line: Spring 2022

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