40th Annual J.P. Morgan Health Care Conference
January 2022
Join CEO Martin Meeson at these events
Clinical As you move through your Drug Development Process, finding the right CDMO partner to support your therapeuticthrough the clinical stages will be extremely important. FUJIFILM Diosynth Biotechnologies offer you specific Phase appropriate expertize and experience to help you reach your goals on time, within budget, and on strategy.
Late phase With only 30% of therapeutics making it through to Phase 3 development, your CDMO partnership and managing your supply chain will become increasingly critical as you move towards process validation to support your Biologics License Application (BLA). By operating as a network, we offer the resources and infrastructure needed to successfully meet your timelines.
Commercialization The goal of the commercial stage is to produce cGMP Bulk Drug Substance utilizing an approved process under a regulatory license to supply customer material needs. However, commercial supply goes beyond making the Bulk Drug Substance. Our post-approval activities include: Process Surveillance, Annual Product Quality Review and Annual Regulatory Support.
What we do
Quality
This is at the heart of everything we do. Quality drives the development and the successful production of your biologics and advanced therapy products from beginning to end, with propriety statistical design tools like RAPTA™ for Laboratory Process Characterization (LPC).
Cell Line/Strain Development
As your partner, we help expedite this process by combining our years of experience with our technologies for microbial expression, Paveway™ PLUS; and mammalian expression, Apollo™ X.
Process Development
At FUJIFILM Diosynth Biotechnologies our Process Development philosophy is driven by designing processes for a wide range of expression systems that result in having phase appropriate product controls that will result in successful process execution during cGMP manufacturing.
cGMP Contract Manufacturing
We offer our partners highly flexible clinical and commercial cGMP facilities for the production, by microbial fermentation and cell culture, of biologics and advanced therapies.
With you every step of the way
We are a world leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their therapeutic candidates.
Our mission is to help our customers bring their biologic and vaccine candidates to the clinic and, ultimately, to commercialization.
With over 30 years of experience in process development and cGMP manufacturing, a dedicated staff of over 3,000 and a reputation for excellent customer service, flexibility and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry.
We offer five development and manufacturing facilities located in the USA,
UK and Denmark where we are licensed for the commercial manufacture of sixteen approved products.
Our Service Offerings
Martin Meeson, CEO
United Kingdom
Belasis Avenue, Billingham
TS23 1LH, UKTel: +44 (0) 1642 363511
Denmark
Biotek Allé 1,
3400 Hillerød, DK
Tel: +45 7741 6000
USA
101 J. Morris Commons Lane,
Morrisville, North Carolina 27560, USA
Tel: +1 (919) 337 4477
USA
3939 Biomedical Way,
College Station, TX 77845, USA
Tel:+1 (979) 431 3500
Email: contactfdb@fujifilm.com
www.fujifilmdiosynth.com
Endpoints
LIVE Fireside Chat
January 11 at 1:00 PM EST
Panel
Discussion:
Collaboration Style
January 19 at 9:30 AM EST
Fierce Executive Interview
January 18
11:30 AM EST
Meet our experts at EBD Biotech Showcase and Fierce
Holly Dowling
Manager, Commercial Development
Mike Dunn
VP, Commercial Development
(Biologics)
Don't forget to look for us in the Endpoints publication in February
MICROBIAL FERMENTATION
CELL CULTURE
VIRAL VECTORS & VACCINES
• Recombinant protein expression in E. coli and P. pastoris
• Proven pAVEway™ expression system (E. coli)
• Process and analytical method development
• cGMP manufacturing (100L to 5,000L)
• Drug Substance and Drug Product
• Clinical and Commercial manufacturing
• To learn more, click here
• Recombinant protein expression in mammalian and insect cells
• Proven ApolloX™ expression system (CHO)
• Process and analytical method development
• cGMP manufacturing (200L to 20,000L)
• Drug Substance and Drug Product
• Clinical and Commercial manufacturing
• To learn more, click here
• Viral vectors, recombinant vaccines and oncolytic viruses
• AAV manufacturing platform with industry-leading triple transfection technology
• Process and analytical method development
• cGMP manufacturing (50L to 2,000L)
• Drug Substance and Drug Product
• Clinical and Commercial manufacturing
• To learn more, click here
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