Finding a happy medium: meeting the rising demand for bioproduction media

Recent years have seen shortages of raw materials across the biopharmaceutical industry, including critical components of cell culture media. Here, Marlin Frechette, Chief Quality and Compliance Officer and ISO Management Representative, FUJIFILM Irvine Scientific, shares how the global supplier is adapting to meet the needs of its customers.

Q How is the demand for media for bioproduction evolving worldwide and how are you meeting the needs of this global sector?

MF: With the high rate of growth in the biopharmaceutical market, and pharmaceutical drugs and vaccines moving into clinical trials and commercialization at a fast pace, our customers require full support as their products advance through regulatory approvals. To address these needs, FUJIFILM Irvine Scientific utilizes a global forecasting strategy that incorporates flexibility and consistency while keeping apprised of trends in supply interruptions or bottlenecks to support growth. We also hold Drug Master Files (DMF) for our media products in many parts of the world, stay apprised of global regulations for raw materials and components in each country, and communicate directly with authorities during customer file reviews to answer questions regarding media or raw materials.

To meet the increasing customer production and reliable, regional supply needs, we have built a world-class cGMP manufacturing facility in Europe. The facility encompasses 245,428 square feet of space and increases production capacity by 320,000 kg/year of powder and 470,000 L/year of liquids. The new European site will follow the same certified Quality System as our locations in the US and Japan and includes sustainable initiatives important to FUJIFILM Irvine Scientific and our customers, such as reducing manufacturing water usage, using a membrane bioreactor for wastewater purification, and windmill-powered electricity.

Q What are FUJIFILM Irvine Scientific’s procedures for the qualification of raw materials for media?

MF: To guarantee ultimate safety, consistency, and effectiveness of the cell culture media, FUJIFILM Irvine Scientific has a robust and stringent supplier and raw material qualification and maintenance program. A risk-based approach is used during the qualification process to remove and minimize the potential risks associated with materials used. Once a supplier is qualified, the raw material documentation such as Certificate of Analysis, TSE/BSE statements (to confirm components are free from human- or animal-derived materials), and other relevant documentation are evaluated. We then audit the manufacturing site, production history, and the supplier quality system. Once we receive a new raw material, samples are evaluated and tested in three separate manufacturing lots and processed through our Quality System. The decision to qualify a material for use or not takes all of these actions into account.

Q What is your approach to ensuring continuity of supply?

MF: To secure our supply chain, FUJIFILM Irvine Scientific utilizes multiple risk mitigation strategies, continuous improvement, and custom management as fundamental principles of excellence. We strive to ensure continuity of supply through robust supply agreements with terms and conditions that protect us, as the customer, should a supplier divest or close their business. These contracts also provide us with the right to procure materials up to a certain point in time – typically nine months to a year – until we find an alternative source.

The facility in Tilburg, Netherlands, further solidifies continuity of supply for our European manufacturers. Providing customers with our products from a local source enables FUJIFILM Irvine Scientific to reduce time-to-market and helps to lower drug manufacturing costs. The new facility will use the same raw materials, equipment, and certified Quality System as our locations in the US and Japan, with the consistency of finished goods assured by our standardized raw materials program, equipment validation, adherence to SOPs, and environmental monitoring.

Affiliation

Marlin Frechette
Chief Quality & Compliance Officer (CQO), FUJIFILM Irvine Scientific

Authorship & Conflict of Interest

Contributions: All named authors take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Acknowledgements: None.

Disclosure and potential conflicts of interest: The author is an employee of Fujifilm Irvine Scientific. The author declares that they have no other conflicts of interest.

Funding declaration: The author received no financial support for the research, authorship and/or publication of this article.

Article & copyright information

Copyright: Published by Cell and Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Attribution: Copyright © 2021 FUJIFILM Irvine Scientific. Published by Cell and Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0.

Article source: Invited.

Interview conducted: Nov 1 2021; Publication date: Dec 14 2021.