Scalability Considerations for Technology Transfer

December 13, 2016 / Jasmina Xie & Ricardo Ibarra

Scalability Considerations for Technology Transfer Structures, Tools, and Systems

The steadily growing and aging

global population has a need for new and better

medicines and for an adequate supply of safe food.

Our innovations offer answers to these challenges. We invent

new molecules which can positively influence the biochemical

processes in living organisms with the goal of improving

the quality of life. That is what our mission

“Bayer: Science For A Better Life”

stands for.

Our MissionBayer: Science For A Better Life

Bayer • Scalability Considerations for Tech Transfer Structure, Tools, and Systems • December 2016Page 2

Our Business Areas

Bayer • Scalability Considerations for Tech Transfer Structure, Tools, and Systems • December 2016Page 3

Pharmaceuticals Consumer Health Crop Science• Prescription drugs • Over-the-counter medicines,

dietary supplements,dermatology products,foot care and sunscreen

• Innovative crop protectionand seeds

Maximizing Success of a Technology Transfer

• Information being transferred is technical, but the transfer process itself is a

Business Process

• Degree of execution leads to speed to market

• “Give me 20 years! I can transfer anything!”

• Technology transfer can occur without tools and systems

• Technology transfers can be successful without proper scoping and

planning

• To maximize success, minimize risk to failure

• Technology transfer structures, tools, and systems help maximize success

• Speed comes from having the right tools, right information, right resources -

where you need them, when you need them

• Dependent on how you plan, scope, and resource the project

• Bayer • Scalability Considerations for Tech Transfer Structure, Tools, and Systems • December 2016Page 4

Considerations When Planning the Technology Transfer

• Goal: Accurately scope a technology transfer

• Scope differs on:

• Lifecycle of product

• Facility

• Capital expenditure

• Location and language

• Company culture

• Complexity of the product and process

• Differences in scale

• Tools need to scale based on scope


Technology Transfer Tools (1 of 3)

• Gating processes – Stage

gate approach to

technology transfer

• Typical Timelines –

Leveraged from previous

technology transfers

• Loaded resource charts –

Leveraged from previous

technology transfers


Abraham S., Bain D., Bowers J., Kenty H., Larivee V., Leira F., Tsang J., Xie J. "Overview of Best Practices for Biopharmaceutical Technology

Transfers." PDA Journal of Pharmaceutical Science and Technology. Vol. 69, No. 5 (Sept-Oct 2015): 645-649.

Bain D., Hohwald S., Toso R., Tsang J., Xie J. "Risk Management In Biologics

Technology Transfer". PDA Journal of Pharmaceutical Science and Technology (2016).

Web. 15 Nov. 2016.

1.5 FTE

2.0 FTE

1.0 FTE

0.5 FTE

0.5 FTE

1.0 FTE1.0 FTE

1.0 FTE1.5 FTE

1.0 FTE2.0 FTE2.0 FTE5.0 FTE

3.5 FTE1.0 FTE

1.0 FTE

1.0 FTE1.5 FTE

2.0 FTE

2.0 FTE


• Team structures

• Size and Composition of

Team – Resource allocation

• RACI – Roles and

Responsibilities

• Governance &

Communication structures –

Metrics and Meetings


Bain D., Hohwald S., Toso R., Tsang J., Xie J. "Risk Management In Biologics Technology Transfer". PDA Journal of Pharmaceutical Science and Technology (2016). Web. 15

Nov. 2016.

Gabriele, Mirko, et al.. PDA Technical Report No. 65, Technology Transfer. 1st ed. Bethesda: Parenteral Drug Association, 2014. Print.


• Due diligence and facility fit

checklists

• Gap assessment methodology

• Risk assessment and

remediation methodology

• Knowledge management


Examples of Scalability when Planning for Transfer and Creation of Documents

• Standardized Documentation Package

• Engineering documentation creation

• Multi-lingual considerations


Standardized Documentation Packages (SDP)

• Standardized Documentation Packages

comprise product knowledge and

documentation to facilitate transfer

• Product and process characterization

• Manufacturing procedures

• Equipment and facility

• Raw materials

• Analytical methods

• Etc.

• Completion status and number of

documents dependent on product lifecycle

• Aligned expectations with development

groups ensures that the information

needed is available when transfer occurs


SDP: Dependent on Product Lifecycle

Chart goes here


Key

N/A Not applicable

I If available /

requested

D Draft needed

R Required

Types of Documentation Preclinical Phase I/II Phase III Commercial

Equipment

- List I D R R

- URS N/A D D R

- DQ/IQ/OQ/FAT & SAT I R R R

- PQ N/A R R R

- Process flow diagram I R R R

Process

- Process Descriptions I D R R

- Samples I R R R

- Process Control Strategy I D D R

Raw Material

- List I R R R

- Specifications I R R R

- Testing requirements N/A R R R

Validation

- Processing Times / Hold times /

Intermediate hold times

N/A I/D D R

- Mixing qualification N/A I D R

- Cleaning qualification N/A I D R

- Resin and membrane lifecycle N/A I D R

- Extractables / Leachables N/A N/A I R

- Pathogen safety N/A I R R

Platform vs Greenfield

Engineering Documentation Creation

Page 12 • Bayer • Scalability Considerations for Tech Transfer Structure, Tools, and Systems • December 2016

Platform Facility FTEs

Facility

- Process/Personnel/Raw Material flow N 0

- Room Classification N 0

- Process Temperature Profile L 1

- Product Storage L 1

- Personnel Considerations L 0.5

- Storage for Materials L 1

Utilities

- Utilities list N 0

- Specifications N 0

- Commission and Qualification N 0

Equipment

- List N/L 0 - 0.25

- URS N/L 0 - 0.25

- DQ/IQ/OQ/FAT & SAT N/L 0 - 1

- PQ M 4

- P&ID N/L 0 - 2

Key

N None

L Low

M Medium

H High

Greenfield FTEs

M/H 6

M/H 6

M/H 3

M/H 2

M/H 1

M/H 2

M/H 0.5

M/H 4

M/H 6

H 1

H 6

H 10

H 4 -10

H 10

Disclaimer: Numbers are theoretical to illustrate a concept

Multi-Lingual Considerations – “We all speak English, right?”


• Process documents are transferred from the Sending Unit (SU)

to Receiving Unit (RU)

• Documents at RU may need to be in another language

• Document verification is needed to maximize success of

project and minimize process drift

• Additional time and resources needed for:

• Establishing a system of verification

• Translation – by a translation agency or RU personnel

• Training of RU to enhance process understanding and

improve communication between both sites

• Verification of translated process documents

Scalable Technology Transfer Tools and Systems

• To maximize the chances of technology transfer success, one must assess

the scope of the technology transfer accurately

• Every technology transfer is different and there is no one-size-fits-all solution

for tools and systems

• Best practice: technology transfer business process with tools, systems, and

structures that are scalable and modular based on scope


Acknowledgements

• Jonathan Tsang, Assoc, Dir., API Operations Lead, Technology Transfer

• Teit Agger, VP of Global Biotech Production Technology

• Global rFVIII Process Mgmt – API Technology Transfer

• BJ Bruce

• Eric Nakasako

• Mimi Yuen

• Jean Benjauthrit

• Bryan Tran

• Jennifer Tom

• Will Asuncion

• Scalability Considerations for Tech Transfer Structure, Tools, and Systems • December 2016Page 15

Questions?

This website/release/presentation may contain forward-looking statements based

on current assumptions and forecasts made by Bayer management.

Various known and unknown risks, uncertainties and other factors could lead to

material differences between the actual future results, financial situation,

development or performance of the company and the estimates given here. These

factors include those discussed in Bayer’s public reports which are available on the

Bayer website at http://www.bayer.com/.

The company assumes no liability whatsoever to update these forward-looking

statements or to conform them to future events or developments.

Forward-Looking Statements


Thank you