© BioPharm Services Ltd Biopharm Services Adding Value to Bioprocesses Minimising CoGs Across the Enterprise, Collaboration & Standardisation Andrew Sinclair - Managing Director & Founder [email protected] www.biopharmservices.com
© BioPharm Services Ltd
Biopharm Services Adding Value to Bioprocesses
Minimising CoGs Across the Enterprise,
Collaboration & Standardisation
Andrew Sinclair - Managing Director & Founder
www.biopharmservices.com
© BioPharm Services Ltd 2 CONFIDENTIAL
Industry Trends
Healthcare providers are putting pressure on the industry to reduce prices
Facility planning from construction to licensure takes 5 years, and it is getting more expensive
Sales forecasts for breakthrough therapies are highly uncertain
Production output is uncertain at time of facility build decision
Increase threats from biosimilars
14%
21%
19%9%
37%
Price Breakdown
Manufacturing R&D Sales & G&A Profit share Pre tax profit
© BioPharm Services Ltd 3 CONFIDENTIAL
Industry Cost Trends
Productivity in development is reducing
As spend per drug increases
Productivity is decreasing
Now overall cost of bringing a successful biologic to market is between $0.8bn to $1.2bn
Manufacturing costs are increasing proportionately
20 years ago about 3% of sales price for chemical candidate
Biologics range between 10% to 20%1
Healthcare providers are putting pressure on the industry to reduce prices by looking at the cost benefit balance2
1. In a recent GE Healthcare webinar they quoted a figure of 14% 2 . The Evidence Gap British Balance Benefit vs. Cost of Latest Drugs, December 3, 2008, New York Times
© BioPharm Services Ltd 4 CONFIDENTIAL
Conclusions
Industry has achieved great success
Costs are now a major driver
In development improved success rates reduce costs
Manufacturing costs are increasingly important
Need greater understanding of costs
Implications of process & technology choices
The earlier in development the better
Managing Process Knowledge
Consistent & standard formats
Streamline process development & deployment
© BioPharm Services Ltd 5 CONFIDENTIAL
Process Economics
Process Models In house solutions
Spreadsheets many issues
The problem! Individual solutions
Not shared
Poor data integrity
Poor communication
Inefficient operations
Capital Costs
Analytical Data
Process
Performance
Data
Plant
Performance
Data
Process
Development
Data
Unit Operation
Data
Plant Design
Manufacturing
recipes
Technology
Transfer
Package
Labour Costs
Materials Costs
Validation
Packages
Maintenance
History
Capital Costs
Analytical Data
Process
Performance
Data
Plant
Performance
Data
Process
Development
Data
Unit Operation
Data
Plant Design
Manufacturing
recipes
Technology
Transfer
Package
Labour Costs
Materials Costs
Validation
Packages
Maintenance
History
Capital Costs
Analytical Data
Process
Performance
Data
Plant
Performance
Data
Process
Development
Data
Unit Operation
Data
Plant Design
Manufacturing
recipes
Technology
Transfer
Package
Labour Costs
Materials Costs
Validation
Packages
Maintenance
History
Capital Costs
Analytical Data
Process
Performance
Data
Plant
Performance
Data
Process
Development
Data
Unit Operation
Data
Plant Design
Manufacturing
recipes
Technology
Transfer
Package
Labour Costs
Materials Costs
Validation
Packages
Maintenance
History
Capital Costs
Analytical Data
Process
Performance
Data
Plant
Performance
Data
Process
Development
Data
Unit Operation
Data
Plant Design
Manufacturing
recipes
Technology
Transfer
Package
Labour Costs
Materials Costs
Validation
Packages
Maintenance
History
Capital Costs
Analytical Data
Process
Performance
Data
Plant
Performance
Data
Process
Development
Data
Unit Operation
Data
Plant Design
Manufacturing
recipes
Technology
Transfer
Package
Labour Costs
Materials Costs
Validation
Packages
Maintenance
History
Capital Costs
Analytical Data
Process
Performance
Data
Plant
Performance
Data
Process
Development
Data
Unit Operation
Data
Plant Design
Manufacturing
recipes
Technology
Transfer
Package
Labour Costs
Materials Costs
Validation
Packages
Maintenance
History
Capital Costs
Analytical Data
Process
Performance
Data
Plant
Performance
Data
Process
Development
Data
Unit Operation
Data
Plant Design
Manufacturing
recipes
Technology
Transfer
Package
Labour Costs
Materials Costs
Validation
Packages
Maintenance
History
Islands of Multiple
Data Sets
© BioPharm Services Ltd 6 CONFIDENTIAL
Requirements Provides the solution through
Managing process information and related data
Materials
Consumables
Equipment sets
Process models
Data Integration & Standardisation
Defined data structure
Common methods/models
Integrated data sources
Accessibility across the enterprise
Import/export
Security model
Access, tracking & auditing
© BioPharm Services Ltd 7 CONFIDENTIAL
BioSolve Delivers Integrated Enterprise Solution
© BioPharm Services Ltd 8 CONFIDENTIAL
Terminology
BioSolve
Is the name of the product family
BioSolve Process
Process modelling package (in Excel)
BioSolve Process Professional [sold on a per machine basis]
BioSolve Process Enterprise [licenses are managed centrally]
BioSolvePLM
Manages resource data sets that includes libraries of consumables, equipment etc.
Platform for a range of future products
BioSolve Connect
Centrally manage multiple datasets for BioSolve Process this references data from BioSolve PLMs libraries
© BioPharm Services Ltd 9 CONFIDENTIAL
BioSolve Connect The Enterprise Solution
Central Resource
Management
Everyone shares same
data
Central Unit Op Models
Everyone shares same
methods
Multiple Data Sets
Tailor to facilities or
technologies
Central Management
Manage distribution &
updates
© BioPharm Services Ltd 10 CONFIDENTIAL
BioSolve Connect Applications Examples
Application Benefits
Fit a process to a facility quickly
Maintain different facility data sets • Which is the best fit • Which is the least cost
Maintain reference processes
Ensure a common reference across the Enterprise • Effective decision making
Tailored data sets for processes
Different processes need different configurations • Vaccines vs. cell therapies vs. proteins etc.
Sharing & transferring processes
Move a process to different groups • Transfer methods & resources seamlessly
Evaluating technologies
Evaluate & distribute the latest technologies • Identify the right cost & application • Avoid costly mistakes
© BioPharm Services Ltd 11 CONFIDENTIAL
BioSolve Connect Platform for Process Deployment
BioSolve Process Users
Understand and evaluate
In a trusted environment
Operation Library
Centrally managed
Assembled for deployment
Target key clients
Selected distribution
Innovative Technologies
Scaling rules, recipes
Standard operations
Standard processes
© BioPharm Services Ltd 12 CONFIDENTIAL
BioSolve Connect Helping you make informed decisions quickly
Application Benefits
Managing process & resources centrally
• Everyone shares the same data • Seamless automated updates • Consistent and informed decisions
Custom data sets • Quickly evaluate the cost effective process • Rapid technology adoption • Screen processes for manufacturability • Optimise cost and minimise risks
Controlled distribution • The right people get the information • Avoid mistakes through consistent data
© BioPharm Services Ltd 13 CONFIDENTIAL
Supporting decision making early on
Understand impact of choices
Identify the cost drivers
Identify fit early on
Solving problems before they happen
Optimising for the facility
Screening processes
Supporting Tech transfer
Standard reports
BioSolve Process
© BioPharm Services Ltd 14 CONFIDENTIAL
BioSolve Process Addressing your needs
Process optimisation
Technology evaluation
Capacity analysis
Facility fit
Sensitivity analysis
© BioPharm Services Ltd 15 CONFIDENTIAL
Manufacturability Assessments Reduce risk
Stages
First pass analysis Rapid analysis Based on BioSolve Process, processes
Basis Equipment list specific to a facility Equipment has a defined capability Review support equipment
Fit process to facility data set
Reports
Fit analysis
Yes, no or nearly
Main constraints
Support equipment
Required equipment
Capabilities
All main equipment
Impact of constraint removal
© BioPharm Services Ltd 16 CONFIDENTIAL
Continuous Processes Evaluate the latest technologies
Template unit operations available within the process library:
Perfusion production bioreactor
Depth filtration
Bind & Elute chromatography
UV virus inactivation
Flow through membrane adsorber
Viral filtration
Concentration
Diafiltration
Sterile filtration
© BioPharm Services Ltd 17 CONFIDENTIAL
Capacity Analysis Understanding constraints
Define shift durations
Used to assess the number of shifts that a unit operation spans
Downtime added to adjusted duration if multiple shifts spanned
Impacts upon production capacity if the unit operation is a bottleneck
Shading highlights the production bottleneck
© BioPharm Services Ltd 18 CONFIDENTIAL
BioSolve Process Analysis & reports
Scenario analysis Cashflow & NPV
Sensitivity analysis
© BioPharm Services Ltd 19 CONFIDENTIAL
BioSolve Process Flexible, User configured, Scaleable
Uses
Therapeutic proteins
Vaccines
Cellular therapy
DNA Vaccines
Egg based flu
Peptides
Oligosaccharides
And more…..
© BioPharm Services Ltd 20 CONFIDENTIAL
BioSolve Process Helping you make informed decisions quickly
Application Benefits
Optimise process in early development
• Identify cost drivers early • Optimise the process where the
opportunity exists
Assess manufacturability
• Screen processes for manufacturability • Ensure key issues are addressed early on
in development • Identify the cost effective manufacturing
sites
Screen and evaluate technologies
• Assess a new technology rapidly • Apply the right technology in the right
application • Maximise the opportunity
© BioPharm Services Ltd 21 CONFIDENTIAL
BioSolve Service Offering
Annual cost database update
Development upgrades
Access to online helpdesk
Optional
Training packages (highly recommended)
Consultancy support for custom configuration
Setting up your technologies
Setting up your processes
© BioPharm Services Ltd 22 CONFIDENTIAL
Real Demonstrable Value Case studies
Integrating technologies in BioSolve: Pall Cadence
single-pass TFF
Developing business cases for new products & new technologies
Process models guiding process development
Process cost & facility considerations when selecting cell culture clarification technology
and
Magdalena Stepien, Crucell "BioSolve enables us to develop robust , cost effective downstream processes in our development group"
Jim Velez, Merck & Co "Use the right tool. For our case to assess impact of innovative technology BioSolve was the right tool. We were able to generate multiple scenarios and sensitivity rapidly."
Jean-Marc Guillaume, Sanofi Pasteur "In these challenging times BioSolve helps you deliver the optimum process technology mix wherever you are in the product lifecycle"
© BioPharm Services Ltd 23 CONFIDENTIAL
Coming Soon
2. How Well Does Your Process Fit into a Facility?
3. What Cost Antibody Drug Conjugates?
4. Potential of Continuous Processing in Downstream
5. When and where to use Pre-packed columns a cost perspective
6. Optimising Design During Concept Case Study Clinical Supply Facility
Sign up now for these webinars on: http://www.biopharmservices.com/webinars Any questions? Contact us at: [email protected]