40th Annual J.P. Morgan Healthcare Conference
January 2023
Join CEO Martin Meeson at Fierce!
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
Sustainable Operations: A New BioManufacturing Paradigm
10:40am – 11:00am
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
Click to play
Cocktail Reception Opening Remarks
4:15pm
Reception
4:15pm – 5:15pm
Venue:
Fairmont Hotel
950 Mason St.
San Francisco, CA
Grand Ballroom
Introducing an operational paradigm in BioManufacturing that focuses on flexibility and reliability to allow for efficient response to changes in product demands
Click to view full live agenda
Date:
Tuesday, January
10th, 2023
Playing the long term game by making efficient and responsible use of the world's resources for sustainable operations
Being ready to respond quickly to changes in technology
United Kingdom
Belasis Avenue
Billingham, TS23 1LH
UK
Tel: +44 (0) 1642 363511
Denmark
Biotek Allé 1
3400 Hillerød
DK
Tel: +45 7741 6000
United States of America
101 J. Morris Commons Lane
Morrisville, North Carolina, 27560
USA
Tel: +1 (919) 337 4477
United States of America
3939 Fujifilm Way
College Station, Texas, 77845
USA
Tel:+1 (979) 431 3500
United States of America
2430 Conejo Spectrum Street
Thousand Oaks, California, 91320
USA
Tel: +1 (805) 699 5579
United States of America
300 N. Beacon Street, Suite 102
Watertown, Massachusetts, 02472
USA
Tel: +1 (617) 798 5211