Fujifilm Diosynth Biotechnologies General Introduction October 2016 Value from Innovation
Safety information Accompanied by FDB staff at all times Fire alarm. Follow host to assembly point Toxic alarm. Stay in building Labs. Wear lab coat and safety specs PPE (Personal Protective Equipment)
What do we do? FUJIFILM Diosynth Biotechnologies is a dedicated biopharmaceutical CDMO business CDMO = Contract (Biopharmaceutical) Development and Manufacturing Organisation Contract means we work on our customers products only
The products we make for our customers are for a wide range of indications, at varying stages of drug development. Customer : Dyax Corporation Indication : Hereditary Angioedema Clinical Phase : Licensed Cylinder Indication : Obesity Clinical Phase : I TwoSevenSeven Indication : Lung Disease Clinical Phase : I Blackadder Indication : Type 2 Diabetes Clinical Phase : II Eurocalin Indication : Kidney Disease Clinical Phase : I Sushi Molecule : Gelatin Phase : III Iguana Indication : Autoimmune Disease Clinical Phase : I Shepherd Indication : Lysosomal Storage Disease Clinical Phase : I Mosquito Indication : Malaria Vaccine Clinical Phase : I Starbucks Indication : Infectious Disease Clinical Phase : I Pallas Indication : Oncology Clinical Phase : Preclinical Jericho Indication : MRSA Clinical Phase : I Haematos Indication : Bleeding disorder Clinical Phase : I Customer : ThromboGenics Indication : Vitreomacular Adhesion Clinical Phase : Licensed Oasis Indication : Dry Eye Clinical Phase : II Magellan Indication : Inflammatory Disease Clinical Phase : I Lapis Indication : Growth Hormone Clinical Phase : II Nordwand Indication : Asthma Rajma Indication : Kidney Disease Clinical Phase : II Mariana Indication : Multiple Sclerosis Clinical Phase : III Tortola Indication : C. difficile infection Clinical Phase : Preclinical Jim Platt Indication : Multiple Sclerosis Clinical Phase : II Acorn Indication : Inflammatory Disease Clinical Phase : II Wax Indication : Growth deficiency Clinical Phase : III Paean Indication : Lupus Clinical Phase : III Peggy Indication : Oncology Clinical Phase : III Clinical Phase : III Approved by NICE 4
FUJIFILM pharma activities AND YOU THOUGHT WE WERE JUST THE WORLD S LARGEST FILM AND IMAGING COMPANY JV with Mitsubishi Corp.
Business Headlines RTP, NC, USA Biologics PD & Manufacturing College Station, TX, USA Viral Vaccines and Gene Therapy PD & Manufacturing EU and USA operations ~1000 staff Recombinant proteins and viral vaccines >230 development products and processes 5 Commercial Products (3 microbial) Process innovation focus Extensive inspection history Billingham, UK Biologics PD & Manufacturing
History 1995 2000 2005 2009 2011 2013 2015 7
The Stages of Clinical Trials Drug Discovery Preclinical Clinical Trials FDA Review Scale-Up to Mfg. Post-Marketing Surveillance PRE-DISCOVERY ~ 5,000 10,000 COMPOUNDS 3 6 YEARS 250 IND SUBMITTED 5 PHASE 1 PHASE 2 NUMBER OF VOLUNTEERS 6 7 YEARS PHASE 3 20 100 100 500 1,000 5,000 NDA SUBMITTED ONE FDA- APPROVED DRUG 0.5 2 YEARS INDEFINITE 8 Sources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org; CBO, Research and Development in the Pharmaceutical Industry, 2006.
Good Manufacturing Practice (GMP) Regulatory requirements for manufacture of pharmaceuticals Clean rooms Prevent contamination of product from environment Separate cell growth and purification Prevent contamination of product by production organism Separate product streams Clean between batches Prevent contamination of product by other products
Contract Manufacturing Pharmaceutical Companies used to do everything Research Manufacturing Marketing But expensive to be experts at everything Contract out work to specialist service providers Increased flexibility Don t have to build new factories
Fujifilm Diosynth Activities Preclinical Phase I Phase II Phase III Regulatory approval Launch Strain development Process invention Pre-clinical Manufacture Process Development & Optimisation Analytical Development cgmp Manufacture Stability Process Characterisation Process Validation cgmp Manufacture Stability cgmp Manufacture Post-approval activities Supporting customers through the development journey
Track Record > 20 years CMO experience 5 Commercial Products > 250 Molecules Developed > 1000 cgmp Batches Manufactured > 50 Mammalian Cell Culture Programs > 200 Microbial Programs > 50 antibodies and antibody-like molecules > 200 non-mab recombinant proteins Inspected by all major regulatory authorities
Made by Fujifilm Diosynth All recently approved by the FDA Hereditary angioedema Prostate cancer Vitreomacular adhesion
Global GMP Manufacturing Facilities Scale UK RTP USA TX USA* Cell culture microbial R&D 10L/200L SUBs 200L/1,000L SUBs 200L 650L / 2,000L Stainless Steel 2,000L SUB 2016 R&D / 100L or 200L microbial 100L or 200L microbial cgmp 2000L microbial cgmp x3 5000L microbial cgmp x2 *BSL2 14
The Billingham Site GMP Warehousing ABC 1000 Facility Fermentation Development Process Development ABC 5000 Facility; QC Conferencing
The Manufacturing Process gene for protein X Host cell FILL INTO BOTTLES = a recombinant organism PURIFICATION protein X plus other proteins protein X >95% pure mix of cells, protein X, other proteins SEPARATION FERMENTATION 5 litres to 5000 litres hours a few days waste cells contaminating proteins
R&D Team Structure Upstream Processing Fermentation Mammalian Cell Culture Molecular Biology Microbiology Primary Separation Downstream Processing Purification Characterization Analytical Development Method Development Method Qualification Transfer to QC (Pre-)Formulation Process Design Process Characterization Robustness Studies Process Validation 1.8 1.6 1.4 1.2 V I P [ 7 ] 1.0 0.8 0.6 0.4 0.2 0.0 M e th a n o l f E x it _ C O 2 C E R E x it_ O 2 O U R S T I R R R Q I n le t _ C O 2 E x t r a O 2 G ly c e r o l f In let _ O 2 P O 2 T E M P A I R F L p H 17 17
UK R&D Team Headcount UK R&D based in Billingham: ~179 staff >95% Graduates: >40% Higher Degrees 4 11 48 35 5 76 Expression and Cell Sciences Downstream Processing Process Design Analytical Development Manufacturing Support Management & Support 18 18
Customers Small/Medium biotechs 1-100s people US, Europe, Japan etc Large pharma Others US/UK government Other non commercial institutions
Fundamental Programme Style Focus on Delivery on time, on cost, to Quality High Transparency Full visibility of data and progress High Flexibility Meeting changed customer needs Interactive Benefit from FDB past experience Listen to customers Encourage cross-site visits and working TRUST Commitment Teams largely dedicated to customer programmes 20