For 25 years the companies that today make up Fujifilm Diosynth Biotechnologies (FDB) have been at the heart of the biopharmaceutical outsourcing industry making it one of today’s leading players. With sites in the northeast of England, UK, North Carolina and Texas it is a globally recognized ‘top table’ Biologics Contract Development and Manufacturing Organization known as a CDMO providing its partner clients a wide range of services and solutions needed to ensure successful drug clinical development through commercialization to approval and long term manufacture across the full range of recombinant proteins, vaccines, monoclonal antibodies, other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems.
Fujifilm’s mission to deliver recombinant proteins, viral vaccines and gene therapies to the patients requires long term commitment and partnerships built on successful delivery underwritten with transparency and trust
Being a CDMO, Fujifilm Diosynth Biotechnologies mainly focuses on combining technical leadership in cell culture, microbial fermentation and advanced therapies with world-class cGMP (current Good Manufacturing Practice) manufacturing facilities to advance tomorrow’s medicines. By doing this, the firm builds long-term relationships in the market that enable its partner’s clinical and commercial success.
The company provides its clients with unrivaled product experience including:
- Process development and manufacture of over 310 biologics
- Licensed manufacturer for six commercial products
- Over 2,000 cGMP batches manufactured at range of scales from 100 liters to 5000 liters with a 20,000 liter scale microbial facility under construction in collaboration with MSD
- Creators of the class-leading pAVEway™ microbial expression technology and the Apollo™ CHO Cell Line System
- Strong inspection history with the major global regulatory agencies
A Trailblazer with Biopharmaceutical Expertise
Steve Bagshaw is the Chief Executive Officer at Fujifilm Diosynth Biotechnologies. As CEO Steve has global responsibility for all the business activities of Fujifilm Diosynth reporting directly to Fujifilm Corporation in Tokyo. He has been CEO for 4 years and a senior business leader for 15 years in this company. He has extensively contributed to the development of Biologics Contract Development and Manufacturing sector both in UK and US, with this company and its predecessors. Prior to Fujifilm Diosynth, he served as President at Image Polymers Inc, a joint venture between Mitsui Chemicals and Avecia for three years and prior to that had a number of roles across the pharmaceutical intermediates and specialty chemicals industries having graduated from Manchester University in the UK as a Chemical Engineer. He is a fellow of the Institute of Chemical Engineers and was awarded the North East England Business Executive of the Year Award in 2018 in recognition of the outstanding growth and success of Fujifilm Diosynth under his leadership as well as his national contribution as Chair of the UK Industrial Biotechnology Leadership Forum and as Co-Chair of the UK BioEconomy Strategy Board working with his fellow industrialists and UK Government to create a vibrant vision and action plan to further the use of biotechnology across the societal sectors – healthcare, foodstuffs, fuel and materials.
Providing Auxiliary Solutions
Fujifilm Diosynth offers numerous industry leading solutions including;
Stability Programs for BDS and DP: Fujifilm Diosynth Biotechnologies offers a full suite of testing required to support the release of the drug substance, drug product, and placebo and stability studies. The Quality Control Team works very closely with the Analytical Development Team to ensure a rapid and seamless transfer of analytical methods as programs progress from process development to cGMP manufacture.
Formulation Development: It is an experimental design of a buffer and excipient combination that maintains the integrity of the purified protein during routine bioprocessing, storage, handling, and delivery to the patient. These molecular characteristics will directly impact the formulation development process, at Fujifilm Diosynth Biotechnologies.
Process Characterization: Process characterization is a critical activity during the lifecycle of biopharmaceutical drug development, allowing effective process control strategies to be developed for successful process validation and commercial manufacture.
Process Validation: It is a pivotal lifecycle activity that involves the collection and evaluation of process data and knowledge to establish a defendable control strategy that defines a capable manufacturing process that reliably meets product quality attributes.
An Innovative Journey
While sharing about Fujifilm’s journey Steve mentions “I have personally been on a journey from the 1950’s technologies of my starting days in fine chemicals to the cutting edge of today’s advanced therapies – at every stage of life there has been a blend of experience working with those who have done it all before alongside the tangible excitement of exploiting new technologies.”
“In the early days of pre-computing technology might even be optional. You need to be fast and you need to have a company prepared to act fast with you – my role is to create the environment where this happens,” adds Steve further.
Emerging Future Goals
Personally, as CEO of Fujifilm, Steve is continuously contributing to the company growth investing in smart people partnered by developing and acquiring technology, systems, and assets. Steve lives the company vision of becoming a leading Contract Development and Manufacturing Organization that serves unified biopharma, therapeutics, vaccines, and advanced therapies worldwide.
Steve advises emerging tech enthusiasts who are contributing in the Biopharmaceutical industry. He asserts, “Find awesome people you want to work with doing cool stuff on projects you care about – life’s too short to do anything less.”
Source: The 30 Most Influential Business Leaders in Tech 2018
