Minimising cost of goods

© 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

mailto:[email protected]

http://www.biopharmservices.com/

http://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


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


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


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


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


BioSolve Delivers Integrated Enterprise Solution


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


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


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


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


BioSolve Connect Helping you make informed decisions quickly


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


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


BioSolve Process Addressing your needs

Process optimisation

Technology evaluation

Capacity analysis

Facility fit

Sensitivity analysis


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


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


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


BioSolve Process Analysis & reports

Scenario analysis Cashflow & NPV

Sensitivity analysis


BioSolve Process Flexible, User configured, Scaleable

Uses

Therapeutic proteins

Vaccines

Cellular therapy

DNA Vaccines

Egg based flu

Peptides

Oligosaccharides

And more…..


BioSolve Process Helping you make informed decisions quickly


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


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


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"


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]

http://www.biopharmservices.com/webinars

http://www.biopharmservices.com/webinars

mailto:[email protected]

Minimising cost of goods

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