Technology Roadmapping - BioPhorum trends & Business drivers •Analysis •Metrics Future...
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Transcript of Technology Roadmapping - BioPhorum trends & Business drivers •Analysis •Metrics Future...
© BioPhorum Operations Group Ltd
Technology Roadmapping Introduction
Rajesh Beri, Lonza Biologics Inc
Steve Jones, BPOG,
18-20 May 2016
© BioPhorum Operations Group Ltd
The executive team
May 2016 Technology Roadmapping 2
SC + Roadmap team
Steering Committee
© BioPhorum Operations Group Ltd
Technology Roadmapping Steering Committee
Developed a strong Steering Committee
• Drive Road Mapping
• Decision Making
• Access External Experts
18 companies on the Steering Committee
• We expect more to make the commitment
3
Company Abbvie AstraZeneca Baxalta Bayer Biogen Fujifilmdb GSK Immunogen Janssen Lonza Lilly Merck & Co EMD Serono Pfizer Roche Sanofi Shire Takeda
May 2016 Technology Roadmapping
© BioPhorum Operations Group Ltd
Agenda
Why technology roadmapping is needed for the industry?
What is the ambition, process, structure?
What is the progress & plan forwards?
Technology Roadmapping May 2016 4
© BioPhorum Operations Group Ltd
Complex industry structure has traditionally held back innovation
Biomanufacturers • Develop new technology in isolation
• Standardisation after the technology is launched
Suppliers find it difficult to innovate • Have to guess end user requirements
• Risk-reward balance is poor
New technology that makes it onto commercial programs is often removed to de-risk
Everyone wants to be a Fast Second
May 2016 Technology Roadmapping 5
BioManufacturers
Suppliers
© BioPhorum Operations Group Ltd
The next wave of capacity expansion cannot only use large scale facilities
Extremely high CAPEX • Increasing Payer & Biosimilar
cost pressure
Long build time • Forecasts will never match
real demand and
• Delays time to market
Inflexible • Pipeline trends many more
products in lower quantity
• Eventually towards personalised medicine
Technology Roadmapping May 2016 6
© BioPhorum Operations Group Ltd
Agenda
Why technology roadmapping is needed for the industry?
What is the ambition, process, structure?
What is the progress & plan forwards?
Technology Roadmapping May 2016 7
© BioPhorum Operations Group Ltd
Audacious goal: To agree an industry technology strategy
An industry technology roadmap is – a dynamic and evolving collaborative technology management process for
Determine precompetitive critical needs and drivers,
Identify technology and/or manufacturing targets, and
Assess / Model potential solutions
Goals:
Focus an industry community
Provide direction
Identify critical needs for a specific timeframe by consensus
Technology Roadmapping May 2016 8
Technology Roadmapping
What will the output look like?
Contents
Market trends & Business drivers • Analysis
• Metrics
Future Biomanufacturing scenarios • Assessment
New technology & enablers • Needs
• Difficult challenges
• Potential solutions
NASA
Semiconductor
May 2016 9
© BioPhorum Operations Group Ltd
What is the scope of the Technology Roadmapping process?
Technology Roadmapping
What it is?
Process
• Engage and align industry stakeholders
• Define future needs of the industry, difficult challenges & potential solutions
Stakeholders –
• Biomanufacturers, Supply partner, Regulatory, Academia input
Communication • The needs, challenges and potential solutions to
industry stakeholders to guide innovations
Monitor industry progress
What it is not?
Actual implementation –
• Responsibility of the industry once the consensus on requirements is clear
Focused on short term tactical needs
• Roadmap provides a long term, big picture view of industry requirements
May 2016 10
© BioPhorum Operations Group Ltd
Collaborating on an Industry Technology Roadmap will enable company technology strategy
Technology Roadmapping 11
BioPhorum Industry
Roadmap
• Collaboration of bio-pharmaceutical companies at an industry level engages regulators and supply partners on common industry need / position
Company Strategic Roadmap
• Adaptation to company specific perspectives and business strategy
Company Site
Roadmap(s)
•Application of company technology strategy and sets priority at the site level
Note: A lot of companies are investing in a formal “Technology strategy” role in their organisations. These are the perfect people / roles to contribute to the roadmap process
May 2016
© BioPhorum Operations Group Ltd
Building the industry strategic landscape
Technology Roadmapping May 2016 12
© BioPhorum Operations Group Ltd
Kick-off meeting Feb 2015 - 19 companies contributed to a high level industry roadmap, identifying focus topics for the technology roadmap
Technology Roadmapping
Advanced
integration of
current platform
Speed to clinic
Diversification
of product
groups
Payer pressure
on cost
In region
manufacturing
Personalised
medicine
Portable
modular
manufacturing
Human
resources &
talent
Global
regulatory
strategy
Supplier
management
Inline
monitoring
Real-time
release
Fully automated
robotic facility
Process
intensification
Knowledge
management
Continuous
processing
Modular and
mobile
Modelling data
& integration Regulatory
harmonisation
Sensing
technology
Vendor
interaction
Multi-use and
flexible facilities
Technology
standards
Keep workforce
capable
Preparing the
next generation
capabilities
Industry Trends & Drivers
Roadmap Focus Topics
Capabilities and Enablers
May 2016 13
© BioPhorum Operations Group Ltd
In summary, the 4 main market trends affecting the industry
May 2016 Technology Roadmapping 14
New product classes
Market growth Volume / year / drug
Number of drugs supplied
Global reach and emerging markets
Cost Payer pressure
Biosimilars
Cost of clinical Failure
Uncertainty of approvals and sales
Market Trends
Thanks to Bert Frohlich
© BioPhorum Operations Group Ltd
Capacity Needs
May 2016 Technology Roadmapping 15
Decentralized Production Personalized Medicine
20 50 200 500 1000 2000 5000 10000 20,000 40,000
Economies of Scale Increased Control / Consistency
Market Forces
Nominal Bioreactor Capacity Requirement for Product Manufacture
Frequency
(Number of
Products
Produced)
Limit of SUT
Future? Multi-modal?
Current Capacity Distribution
Thanks again to Bert Frohlich
© BioPhorum Operations Group Ltd
Business drivers
Cost
• Cost per dose
• Cost of development
Flexibility
• Batch size
• Number of platforms
• Changeover time
Quality
• Cost of quality
• Variability
Speed
• End to end cycle time
• Launch speed
• Speed to clinic
May 2016
Cost
Flexibility
Speed
Quality
Technology Roadmapping 16
© BioPhorum Operations Group Ltd
The teams have focused on 4 Biomanufacturing scenarios
May 2016 Technology Roadmapping 17
Scenario – USP DSP Typical Products
1 Stainless Steel > 10K, Batch
Batch /Continuous Mab’s, Mab Fusions, rec Proteins,
2 Disposable ~ 2K, Continuos
Semi Continuos / Continuos
Unstable Products e.g. Factor VIII, Therapeutic Enzymes, Viral Vaccines, Allogenic Cell Therapy
3 Disposable ~2K, Batch
Batch Semicontinuous
Mab’s, Mab Fusions, rec Proteins, Viral Vaccines
4 Disposable < 500L Continuous
Continuous Biologics on Demand, Bioproduction at Bedside, Typically recombinant proteins and viral vaccines in microbial systems
© BioPhorum Operations Group Ltd May 2016 18
Scen
ario
Evo
lution
“What”
Te
chn
olo
gy , c
apa
bili
tie
s &
En
ab
lers
“How”
Bu
sin
ess D
rive
rs
“Why”
Now 10 years 5 years
Cost
Flex
Speed
Low cost <$30g/L DS
Scale-out not scale-up
Clinical –Comm pIII
Continuous processing
Supplier management
Modular & mobile
Real-time release
Knowledge Management
Fully automated
facility
Single use cell retention
device
Capital <$70m full facility
No QC FTE fr release
CoGs high >110g/L
Release of funds to OQ complete
~ 2 yrs
2 g/L/d In clinic
Manufacture to release weeks to
months
Perfusion USP in commercial
Fully integrated processing
Multi-product Commercial
Facility
Rapid changeover 0 extra time
Seamless buffer
operability
Highly/Fully automation
Integrated knowledge
management
Plug & play adaptable
>1000kg 2g/L/dat @ 2000L 4g/L/day @1000L
Multi attribute analytics
Advanced process control
Integrated DP
Process intensification
In-line monitoring
Fully sanitary GMP continuous chromo skids from multiple
vendors
Robust continuous
viral clearance
Deviation management (how much quarantine)
Perfusion ~2kL to DSP semi cont & Cont
Release in 0 days
Multiple platforms Changeover <1 wk between platform
Manufacture to release by exception
Release of funds to PPQ complete
<2 yrs
RFT
MVDA / SBOL
2x200L SUB to integrated
DSP
No clean steam or autoclave
PAT / RTR for raw
materials Clinical PhIII
facility in production
1x 2000L SUB
QC testing takes weeks
Continuous not yet in clinic
Sandbox (industrial collaborative) at
scale
Demonstrate process
robustness
Pipeline into platform
Simplify buffer system
Reduce number of solutions
Low cost media
concentrates
DS ProcDev 3-5 yrs from PhI
process to commercial
Optimize media for perfusion
Perfusion to batch
comparability
Limited GMP continuous
chromo skids
KM platform
Integrity of SU systems (leaks)
not assured
Limited integration automation for SU
facilities
Virus Mycoplasma
Bioburden
Batch definition
Informatics CPV
Convert internal Reg & QA principles
& culture
Standard single use assemblies
/connections and how to support and
run them
Fully SU perfusion
Harvest robust
Very limited SU sensors
In-line of QAs/PP
Multi-attribute analytics
Advanced process control developed
USP x DPS
Supplier Integration
Fully SU sensors
Closed system
USP ↓CSPPR ↑Qp
2g/L/dy < 1VVD
Supplier integration – Connecting
equipment together is complex
Traceability / Firewall
On demand buffer formulation for
continuous
Skills / exp in sensors - Models
Process model for RTR
Technology Roadmapping
© BioPhorum Operations Group Ltd
Substantial benefits can be gained through a cross industry collaboration on the roadmap team topics
19
Roadmap Team Vision Benefit
Process Technology
Process Intensification - Intensifying production through highly concentrated reactants and products and combining unit operations into single units
• Reduction in facility size • Reduced capital investment • Speed to market
Continuous Processing - New separation and media technologies, coupled with advanced automation and process control
• Flexibility for smaller patient populations • Speed • Reduced cost
In-line Monitoring and Real-time release
Process control and assurance of product quality through advanced monitoring devices, in-direct or multi-attribute sensors, and PAT.
• Tighter product and process control • Reduced cost of quality • Enables real time release
Global regulatory testing standards, advanced process control strategies and raw material characterization.
• Eliminate $Bn’s of inventory • Product released 1-2 days after manufacture • Reduce quality costs
Modular and Mobile
Manufacturing systems that are quick to configure and assemble using ‘plug and play’ standard designs
• Scalable capacity • Manufacturing process available in weeks
rather than years.
Fully Automated Facility
Scale up from development to manufacturing, with a focus on automation, equipment, and biology, results in a fully automated facility.
• Consistent high product quality • Reliable supply • Reduced time to market.
Supplier Management
Suppliers become technology development partners for our industry, collaborating to solve problems.
• Innovative supply partners • Industry needs delivered faster and better
Knowledge Management
Integrated knowledge of product and process technology across the development, manufacturing and commercial value streams
• Speed to market • Cross-product learning • Efficiency throughout product lifecycle.
May 2016 Technology Roadmapping
Process Technologies
Please define what your sensors need to measure - - Product quality - - media
Before Continuous, need full
automation of unit ops
TOP
5
Scenario 2 + 3 2k Batch/Perfusion
Upstream
Does PD have impact on pdt
quality – start & end?
+ intensified ------------ Perfusion [10 days]
+ perfusion ------------
Continuous Harvest
Media
Seed Train
Production Bioreactors
Harvest
Facility/ Automation
Consumables RM
Regulatory
Personal exchange between Biopharma/Medium vendor to develop customised medium
Host cell line development
for Rolling Seed technology
Closed Scale-up
Foam-sensing vision system for automated
controll
ATF 2k Fully disposable;
Robustness Improved
Shaken & Stirred bioreactor for
high turnaround - one bioreactor
Improved filter for venting
Media most input on ACQA
Improved media sterilization
-improved filters - alternate tech.
2k Batch Disposable HTST for
media Other treatments
(virusfilter)
Alternate CO2 removal strategy to enable O2 only gassing & no foam
Standard seed train
1:10 split
More robust tech.
Better weldevs ½-1”
Improved foam
reduction technology
Design product for high perf mfg
Increase bag customize speed by
vendor (ie <2 months)
Number of ports in bag
Bag reliability; Lot-to-lot variability
Minimal bag material concern (leachables) & proper control/defect
strategy
Robust bag packaging & delivery from
vendor
Economical single-use centrifuge
Ergonomic but smallest possible layout
configurations for lowest cost facilities
Supporting data for fully closed
‘connectors’ for use in non-classified space
EoL Consolidated list of
compounds/test could lower cost for academia to research
5g/L 10 day
Seed train & prod
Closed processing - Production bioreactor unclassified - including scale-up - Downstream bioreacto Class D or E
Process Automation;
Reduced intervention
Harvest to support high
density
Faster changeover
‘limited’ changeover
Reduce or eliminate IP
sampling
Implement disposable
probes
Faster, robust RM testing /
release
Faster cycle times
<10d Prod. Brx
Reduced lot-to-lot
varibaility
Media High concentrations
Liq-liquid reduced components
Improved mass transfer
matches cell type/density
Robotic cell scale-up in
isolator
Proper gassing strategy for high density process
Reduced cost of filter for cell
sep.
Improved inline disp. Sensors
-DO, cell density
TOP
5
Large cell bags -Robust -Low temp -P/T -automatic dispensing
R-T stable Media
Microbial media?
Storage of high vol. cell bags
Reliable bio-mass probes (wide
dynamic range)
pH measurement
w/o offline correction
Single-use harvest
technology
TOP
5
Improved filtration (body
feed)
Acoustic separator
blank Robustness
bag film - leaks
Ballroom Concept - No segregation
classified in F
Reliability of bag ‘integrity’
Reliability of bag film
(leachables)
TOP
5
Real-time release –
1 day
High potency products
Managing data & using it to inform
process with enhanced PAT
tools
Inline characterization
of product quality
Sensors for BM+
metabolite
ATF Disposable
PAT
20 yrs Sensor
do all-in-1
Ballroom -closed system
upstream & downstream
Single bioreactor scale-up
100ml-500L
Need simple in-line conditioning
(not a chromo skid)
Single use of ATF for N-1 perfusion
Robust disposable pump, not peristaltic
Real-time reconstitution
of medium (powder) -
liquid
Microbial fermentation/
synthetic biologics not detailed
Single use, robust, low cost harvest
tech
10-20g/L 10 day process
Max. seed expansion efficiency
(high density cell bank w/ good vol.)
Multi-product Parallel streams
Interchangeable bags
Not Vendor Specific
Target MAB $1/gm
No changeover
Online sensors
Raw materials – electronic
cofa Min testing
Same-day release
Mnimal / No. release testing
-Qdb, well controlled, well characterized
process
TOP 5
Minimal tech
transfer <1 month
Upstream Team
20
© BioPhorum Operations Group Ltd
Supply partners and academics provided input and ideas to the roadmap team
Technology Roadmapping 21 May 2016
© BioPhorum Operations Group Ltd
Agenda
Why technology roadmapping is needed for the industry?
What is the ambition, process, structure?
What is the progress & plan forwards?
Technology Roadmapping May 2016 22
© BioPhorum Operations Group Ltd
Technology Roadmap plan – 2016 activities
2016
D J F M A M J J A S O N D
Face to face meetings
Roadmap Team (RT) activity
Industry stakeholder engagement in roadmapping
Roadmap content development
Communications
Publish industry roadmap
Stakeholder engagement and input to the roadmap
Chapter detailing Chapter finalising
Final approvals
Mobilise RT’s
TR03 – Roadmap team meeting (12-14 Apr’16)
TR04 – Finalising the roadmap (20-22 Sep’16)
Comms strategy and channels
Comms for progress and launch of roadmap
1st Level Map
2nd Level Map
SC input
Draft due
SC review
Press release
Technology Roadmapping May 2016 23
© BioPhorum Operations Group Ltd
Anti Trust Statement
All BioPhorum meeting activities shall be conducted to strictly abide by all applicable antitrust laws. Meetings attended by BioPhorum members are not to be used to discuss prices, promotions, refusals to deal, boycotts, terms and conditions of sale, market assignments, confidential business plans or other subjects that could restrain competition.
Antitrust violations do not require proof of a formal agreement. A violation may be alleged based upon the mere appearance of unlawful activity. For example, discussion of a sensitive topic, such as price, followed by parallel action by those involved or present at the discussion, may be sufficient to show a price-fixing conspiracy.
Criminal prosecution by federal or state authorities is a very real possibility for violations of the antitrust laws. Imprisonment, fines or treble damages may ensue. BioPhorum, its members and guests must conduct themselves in a manner that avoids even the perception or slightest suspicion that antitrust laws are being violated. Whenever uncertainty exists as to the legality of conduct, obtain legal advice. If, during any meeting, you are uncomfortable with or questions arise regarding the direction of a discussion, stop the discussion, excuse yourself and then promptly consult with counsel..
The antitrust laws do not prohibit all meetings and discussions between competitors, especially when the purpose is to strengthen competition and improve the working and efficiency of the marketplace. It is in this spirit that the BioPhorum conducts its meetings and conferences.
Technology Roadmapping May 2016 24