CONTINUOUS QUALITY

VERIFICATION
(CQV)
G.K.Raju, Ph.D.

Pharmaceutical Manufacturing Initiative (PHARMI),

MIT Program on the Pharmaceutical Industry,
Massachusetts Institute of Technology
July 2001

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

MIT Pharmaceutical Manufacturing Initiative

Objective: To Describe the Opportunity to Improve
Pharmaceutical Manufacturing Performance

Research

Development

Manufacturing

Marketing

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

Pharmaceutical Manufacturing

Research

Inbound
Logistics

Bulk
Active

Development Manufacturing

Bulk
Formulation

Filling &
Finish

Marketing

Packaging

Outbound
Logistics

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

STUDYING PHARMACEUTICAL MFG:

VERTICAL VS. HORIZONTAL APPROACH
VERTICAL
APPROACH
Plant A
Bulk
Active

Plant A
Bulk
Formulation

Filling/
Tableting

Packaging/
Finishing

Plant B
Bulk
Active

HORIZONTAL
APPROACH
Bulk
Active

Bulk
Filling/
Formulation Tableting

Packaging/
Finishing

Bulk
Filling/
Formulation Tableting

Packaging/
Finishing

Plant B
Bulk
Formulation

Filling/
Tableting

Packaging/
Finishing

Bulk
Active

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PHARMACEUTICAL MANUFACTURING
THE HORIZONTAL APPROACH
Company A
Bulk
Active

Bulk
Formulation

Filling/
Tableting/
etc.

Packaging/
Finishing

Bulk
Active

Bulk
Formulation

Filling/
Tableting/
etc.

Packaging/
Finishing

Bulk
Active

Bulk
Formulation

Filling/
Tableting/
etc.

Packaging/
Finishing

Company B

Company C

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

CONTINUOUS QUALITY VERIFICATION (CQV)

DESCRIBING THE OPPORTUNITY

IN
ROUTINE MANUFACTURING

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS CYCLE TIMES

WHICH PROCESSES?
In Process
Development

Biggest Impact Here?

Time-to-market
Enabling
Potent Products

In Routine
Manufacturing

Place for Validation?

Potent Products
Difficult Processes
High Volume Products
Products with Tough QC Tests
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS A WITH QC TESTS

DRY MIX

WEIGHING

QC1
API
MICRO

STEP

WET
GRANULATION

FB DRY

STEP

BLEND

SIEVE

QC2

QC3

ENCAPSULATE

QC4

LOD Particle Size Description

ID
Assay
CU
Impurity
Dissolution
MICRO
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS A WITH CYCLE TIMES

< 3 DAYS
DRY
ProcessingFB DRY BLEND
MIX

WEIGH WETSTEP
GRANULN

7 DAYS

QC2

QC1
API
MICRO

LOD

SIEVE
ENCAPSULATE

QC3
Particle
Size

13 DAYS

QC4
Description
ID
Assay
CU
Impurity
Dissolution
MICRO

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS B WITH QC TESTS

CHEMICAL
WEIGHING

QC1
API
OVI

BLEND

FILL CAPSULES

BOTTLE
PACKAGING

QC2
Description
ID
Assay
CU
Impurity
Dissolution
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS B WITH CYCLE TIMES

17 DAYS

CHEMICAL
WEIGHING

14 DAYS

BOTTLE
BLEND FILL
CAPSULES PACKAGING

7 DAYS

QC1

QC2

API
OVI

Description
ID
Assay
CU
Impurity
Dissolution

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS C WITH QC TESTS

GRANULATION

WEIGHING

QC1
API

FB DRY

COMPRESS

STEP

FILM
BOTTLE
COATING PACKAGING

BLEND

QC2
Particle Size
LOD

QC2
Description
ID
Assay
CU
Impurity
Dissolution

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS C WITH CYCLE TIMES

21 DAYS
GRANULATION

6 DAYS

WEIGHING

QC1
API

FB DRY

STEP

COMPRESS

BLEND

BOTTLE
PACKAGING

FILM
COATING

14 DAYS

QC2
Description
ID
Assay
CU
Impurity
Dissolution

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS D WITH QC TESTS

GRANULATION

CHEMICAL
WEIGHING

QC1
API

Processing

FILM
COATING

STEP

BLEND 1: BLEND 2: FINAL COMPRESS

PREBLEND
BLEND

QC2
Particle Size
LOD

BOTTLE
PACKAGING

QC3
Description
ID
Assay
CU
Impurity
Dissolution

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS D WITH CYCLE TIMES

20 DAYS

15 DAYS

BLEND 2:
PRE-BLEND
FILM
COATING

GRANULATION STEP

CHEMICAL
WEIGHING

PROCESSING

BLEND 1:

FINAL
BLEND

COMPRESS

BOTTLE
PACKAGING

10 DAYS
QC1
API

15 DAYS
QC2

QC3

Particle Size Description

LOD
ID
Assay
CU
Impurity
Dissolution

60 DAYS
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS D WITH QC TESTS:

Cycle Times including BULK ACTIVE

20 DAYS

15 DAYS

BLEND 2:
PRE-BLEND
FILM
COATING

GRANULATION
STEP

CHEMICAL
BLEND 1: FINAL COMPRESS BOTTLE
WEIGHING
PROCESSING
PACKAGING
BLEND

10 DAYS
QC1

21-90 DAYS

15 DAYS
QC2

QC3

60 DAYS
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS D WITH QC TESTS

Cycle Times
20
15
Actual
10

Target
Potential

5
0
QC1

PFD

QC3

20 DAYS

Release

15 DAYS

BLEND 2:
PRE-BLEND
FILM
COATING

GRANULATION STEP

CHEMICAL
WEIGHING

PROCESSING

BLEND 1:

FINAL
BLEND

COMPRESS

10 DAYS
QC1

BOTTLE
PACKAGING

15 DAYS
QC2

60 DAYS

QC3

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

WHAT DRIVES THE

QC TESTING TIMES?
20
15
Actual
10

Target
Potential

5
0
QC1

PFD

QC3

Release

2%
Sampling
Batching
Other Products
Waiting
Coordinating

TEST

Other Products
Other Paperwork
Waiting
Coordinating

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS CYCLE TIMES

WHICH PROCESSES?
In Process
Development

Biggest Impact Here?

Time-to-market
Enabling
Potent Products

In Routine
Manufacturing

Place for Validation?

Potent Products
Difficult Processes
High Volume Products
Products with Tough QC Tests
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS E WITH QC TEST POINTS

ACTIVE

INITIAL GRANULATION STAGE

LOD
MILL

WEIGH

DRY MIX

SECOND GRANULATION STAGE

QC1 WET GRANULN

WET
GRANULN

LOD

DRY

MIX

QC2 SIFT

BLEND

MIX

COATING STAGE

LOD

MILL

SIFT&BLEND STAGE

SIFT

MILL

COAT
MILL

WET GRAN

FL BED DRY

STORE

LOD

GRANUL

DRY

STORE

MIX

MIX

QC3

DRY

QC4

STORE

BLEND&FILL STAGE

BLEND

BLEND

BLEND

STORE

BOTTLE FILL

MILL

EXCEPIENT PREPARATION STAGE

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS E WITH QC TEST TIMES

7 days
QC1

3 days
QC2

7 days
QC3

7 days
QC4

ACTIVE

<1 <1
day day
FIRST SECOND
GRAN GRAN

1-2 < 1
days day
COAT SIFT&
BLEND

<1
day

<1
day

BLEND

FILL

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

TOWARDS PARAMETRIC RELEASE

WHICH PROCESSES?
In Process
Development

Biggest Impact Here?

Time-to-market
Enabling
Potent Products

In Routine
Manufacturing

Place for Validation?

Potent Products
Difficult Processes
High Volume Products
Products with Tough QC Tests
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS F: LIQUID LINE

ENVIRO. MONITORING

WFI TESTING
Endotoxin
TOC

QC Check
WASH AUTOCLAVE

WFI

STOPPERS
WEIGH

QC Check

QC Check
WASH DEPYROGEN

BUFFER

SEALS

VIALS
WEIGH

ID

pH ADJ COMPOUND

WEIGH
ID

TERMINAL
FILL STOPPER CAP STERILIZATION

FILTER
pH

BIOBURDEN

LABEL/PKG
Wt Check

Visual Check Appearance

ID
Assay
Impurity
Fill Vol, Osmolarity, Partic.
Endotoxin
STERILITY TESTING

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS F:
LIQUID LINE WITH CYCLE TIMES
ENVIRONMENTAL MONITORING
7 days

10 days
WFI TESTING
3-4 days

3-4 months

STERILITY TESTING
17-20 days
7 days
BIOBURDEN TESTING

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PERCEIVED PROCESS CYCLE TIMES:

SUMMARY

Process
Flow
A
B
C
D
E
F

Process MICRO Optimized Process

QC QC:Process
Type Test? Process? Cycle Time Cycle Time Time
High Vol. Y
Y
3
20
6.7
High Vol. N
N
17
21
1.2
High Vol. N
N
21
20
1.0
High Vol. N
N
20
25
1.3
Variable N
Y
7
24
3.4
Parentals Y
N
3
20
6.7
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

CYCLE TIME COMPONENTS

STEPS

IN THE PROCESS/PLANT

IN QC/QA

Process/Unit operation
Interruption of the process
Securing of sample from process
Holding of sample in plant
Documentation and verification of sampling
Transferring of samples to QC lab
Batching of samples in QC
Preparation of test samples
Actual test - separation
Actual test - measurement
Test data collection and processing
Documentation and verification of testing
Transferring of results for review
Decision regarding impact on process

Process/Process Step
Inventory Hold

Primarily Manual Operation

Actual test
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

ON-LINE TECHNOLOGY IMPACTS

DOMINANT CYCLE TIMES
STEPS

IN THE PROCESS/PLANT

IN QC/QA

Process/Unit operation
Interruption of the process
Securing of sample from process
Holding of sample in plant
Documentation and verification of sampling
Transferring of samples to QC lab
Batching of samples in QC
Preparation of test samples
Actual test - separation
Actual test - measurement
Test data collection and processing
Documentation and verification of testing
Transferring of results for review
Decision regarding impact on process

Process/Process Step
Inventory Hold

Primarily Manual Operation

Actual test

On-line LIF, NIR, Pattern Recognition, etc.

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

CQV OPPORTUNITY IN ROUTINE MANUFACTURING

SUMMARY

Quality Monitoring is Discontinuous

QC testing times are approximately = 1 month
Factor of 20-25 opportunity in cycle time: Process
Factor of 20-25 opportunity in cycle time: QC
QC Cycle Times >= Process Cycle Times
Time is driven by off-line nature of test
Exception is MICRO test

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

CONTINUOUS QUALITY VERIFICATION (CQV)

DESCRIBING THE OPPORTUNITY

IN PROCESS DEVELOPMENT

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

THE VERTICAL APPROACH

Company A
Bulk
Active

Bulk
Formulation

Filling &
Finish

Packaging

Bulk
Active

Bulk
Formulation

Filling &
Finish

Packaging

Bulk
Active

Bulk
Formulation

Filling &
Finish

Packaging

Company B

Company C

Flow
Rapid
Fermentation Blending
Drying
Tableting Microbial
Granulation Transport Detection
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

VERTICAL ANALYSIS I:

BLENDING UNIT OPERATION

Company A
Bulk
Active

Bulk
Formulation

Filling &
Finish

Packaging

Bulk
Active

Bulk
Formulation

Filling &
Finish

Packaging

Bulk
Active

Bulk
Formulation

Filling &
Finish

Packaging

Company B

Company C

Eg. Blending
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS CYCLE TIMES

WHICH PROCESSES?
In Process
Development

Biggest Impact Here?

Time-to-market
Enabling
Potent Products

In Routine
Manufacturing

Place for Validation?

Potent Products
Difficult Processes
High Volume Products
Products with Tough QC Tests
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

MIT Pharmaceutical Manufacturing Initiative

FOCUS
Explore the Potential Impact of On-line
Monitoring Technology on Blending
Process Development

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

Blending Operation Model

Undermixed
mix-longer

Raw material load

Mixing

Active
Excipients
ingredient

Homogeneous

Blender
cleaning

Sampling

Next batch
Discarded
Next batch

Homogeneity test
OK?

Results & Decision

Making

Analysis

Transporting

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PHARMACEUTICAL MANUFACTURING:
LIF FOR ON-LINE MONITORING OF BLENDING

LIGHT INDUCED FLUORESCENCE SYSTEM

FOR THE DETERMINATION OF THE
HOMOGENEITY OF DRY POWDER BLENDING

4500

LIF Signal Units

4000
3500
3000
2500
2000
1500

A: 5% T/L

1000

B: 5% T/L

500

C: 5% T/L

0
0

10

20

30

40

50

Number of Rotations

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

LIF VERIFICATION STUDIES

Established a correlation between LIF assessment of
homogeneity and thief-sampling with off-line analysis

End Point Determination

6
LIF % Triamterene A
LIF % Triamterene B
Thief Assay A
Thief Assay B

5
4
3
2
1
0
4.75%

3.22%

1.64%

Run Batch

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS D:
BLENDING PROCESS DEVELOPMENT

CHEMICAL
WEIGHING

Processing

FILM
COATING

STEP

BLEND 1: BLEND 2: FINAL COMPRESS

PREBLEND
BLEND

BOTTLE
PACKAGING

OFF LINE QC TEST

Mixing Of 1:10 Triamterene-Lactose
@ 70% Fill & 27.4 RPM

ON LINE SENSOR

PMT Signals, Volts

GRANULATION

40
35
30
25
20
15
10
5
0
0

50

100

150

200

250

300

Number of Rotations

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

Blending Operation: Two Technologies, Two Approaches

Process Development, Validation and Manufacturing

OFF LINE

Raw Materials
Process
knowledge

Blending

Sampling

Transport

Analysis

Results &
Decision making

Waiting Stock

Information Flow
R/D/W

Materials Flow
a- Process Development

ON LINE

Reprocessed

Raw Materials

Discarded

Well Blended

Blending
Analysis &
Decision making

b- manufacturing

Well Blended
Discarded

On-line
Information Feedback
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

Blending Data Collected from CAMP Companies

Operation Characteristics
Low

Medium

High

Cleaning time (min)

20

250

480

Loading time (min)

10

35

60

Discharge time (min)

18

30

Sampling time (min)

60

90

120

Transport time (min)

30

60

QC Testing time (min)

20

250

480

QC Holding time (min)

25

48

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

Results
Blending Performance
Process Development and Validation
6% no wait between blends

Time (days)

1 Blend
Best

2.32 0.36

Med.

13.19 1.31

Worst

25.82 2.57

2 Blends
4.96

3 Blends

0.68

8.45

1.07

23.45 1.93

30.65

2.41

43.40 3.56

56.17

4.46

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

Blending Performance
Process Development and Validation
Impact of the number of blends on total
process time
60

Time (days)

50
40
30.65

30
20

23.45
13.19

10

2.41

1.93

1.31

0
1

Number of blends
Avg Off line

Avg On line
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

APPROACH TO LEARNING:
Consequences on Process Development & Commercial Production
Current Approach

Process Development

Proposed Approach

1a

2a

x
x
xxxxxxxxx
xxx
x

xx
xxxx
x
x xx xx
x x
x
x x x
x

Commercial Production

1b

x
x
xxxxxxxxx
xxx
x

2b
xxxxx
xxx

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

CQV Opportunity in Process Development

SUMMARY

Process development can be on the critical path

Factor of 10-15 reduction in cycle time in blend
process development (maybe more..)
Variability reduction in blend process dev. time
independence of organization/product -> predictability
Benefits not restricted to use of new on-line sensors
improvement data analysis of existing sensor data
use of this for experimental design
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

CONTINUOUS QUALITY VERIFICATION (CQV)

WHAT ARE THE

IMPLICATIONS?

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

Consortium for the Advancement of

Manufacturing in Pharmaceuticals (CAMP)
Pharmaceutical Companies
Abbott

Hoffmann-La Roche

Aventis

Glaxo SmithKline

Bristol-Myers Squibb Wyeth-Ayerst

FDA

Johnson & Johnson

Vendors

CAMP
Purdue

MIT
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PROCESS A WITH CURRENT QC TESTS

AND NEW POSSIBILITIES

DRY MIX

WEIGHING

QC1
API
MICRO

STEP

WET
GRANULATION

FB DRY

STEP

BLEND

SIEVE

QC2

ENCAPSULATE

QC3

LOD

Particle Size

QC4
Description
ID
Assay
CU
Impurity
Dissolution
MICRO

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

Need to Focus on Both

Material Flow and Information Flow
INFORMATION FLOW

Sensor1 (or QC test1)

Bulk
Active

t1

Y1

Sensor2 (or QC test2)

Bulk
Formulation

t2

Y2

Sensor3 (or QC test3) Sensor4 (or QC test4)

Filling/
Tableting/
etc.

Y3

t3

Packaging/
Finishing

Y
Y4

t4

MATERIAL FLOW
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

Manufacturing Information Management:

Has Hardware and Software Components
Fast Response
On-Line
Real-Time
Accurate
Robust

Rapid Rate of Learning

Short Cycle Times
Benchmarking
Modeling
Continuous Problem Solving
20

Mixing Of 1:10 Triamterene-Lactone @ 85%

10.00
5.00

y = 1.9757x + 0.4886

0.0

2.0

4.0

6.0

8.0

10.0

10
5
0
0

R = 0.9983

0.00

30
25
20
15

50

100

150

200

250

Number of Rotations

300

Fluorescence Signals, volts

Signals, volts

PMTSignal, volts

15.00

30

16

40
35

20.00

35

18

Fill (10g) And 27.4 RPM

14
12
10

15

1%

0.5%
0.1%

4
1:10 powder flow

50

100

150

200

50

100

150

200

Number of Readings @ 0.375 s/reading

1:20
0

250

Readings @ 0.375 seconds

% of Triamterene

Sensor1 (or QC test1)

5%

20

10

12.0

10%

25
Signal, volts

25.00

Bulk
Active

Y1

Sensor2 (or QC test2)

Bulk
Formulation

Y2

Sensor3 (or QC test3)

Filling/
Tableting/
etc.

Y3

Sensor4 (or QC test4)

Packaging/
Finishing

Y
Y4

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

HORIZONTAL AND VERTICAL APPROACHES

Company A

High Vol

Bulk
Active

Bulk
Formulation

Filling &
Finish

Packaging

Bulk
Active

Bulk
Formulation

Filling &
Finish

Packaging

Bulk
Active

Bulk
Formulation

Filling &
Finish

Packaging

Company B

Variable
Company C

Liquids

Flow
Rapid
Fermentation Blending
Drying
Tableting Microbial
Granulation Transport Detection
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

CQV: BENEFITS

Data Mining of Process Data

Data -> Information -> Knowledge
Rationale for New Sensors
Variable Categorization: PCCPs, etc.
Basis for Specifications, Batch Record Design
Basis for Experimental Design, Etc.
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

Learning Curve: Cycle Times

Accelerated Learning Curve Facilitated By
Continuous Quality Verification
Total cycle time

days

1000

100

10
0

50

100 150 200 250 300 350 400 450 500 550 600 650 700
batch #

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

CQV: SO WHAT?
On-line sensors doing the same thing will have
only incremental impact
This impact will still be only incremental
even if there is an MES/EBR system
Data Warehousing focused on exceptions can
have a large impact
On-line sensors + EBR + Data Warehousing
can fundamentally change pharma. mfg.
MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

PRODUCT LIFE CYCLE: OPPORTUNITIES

1: NET INCOME
1:

2: NET INCOME

3: NET INCOME

370.88
2
1

Reduction of
manufacturing cost
3

Reduction of
time-to-market
1:

114.92

3
2

1:

-141.04

1.00

8.25

15.50

Net Income (Untitled Graph)

Years

22.75

30.00

7:15 AM Tue, Mar 02, 1999

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

Pharmaceutical Manufacturing:
Opportunity Areas

Manufacturing:
Cost --> Profit
Organizational focus: Functional --> Process
Optimization:
Local --> Supply chain
Inventory Management: JIC --> JIT
Cost of Quality: Inspection --> Prevention

KEY TECHNOLOGY OPPORTUNITY:

On-line Sensors+EBR+Data Warehousing!

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

ACKNOWLEDGEMENTS

Professor Charles Cooney (MIT)

Professor Stephen Byrn (Purdue)
CAMP

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)

NOTE ON CONTEXT

This presentation does not necessarily represent

the views of MIT, Purdue or CAMP
Some data have been disguised for reasons of
sensitivity and confidentiality

MIT PHARMACEUTICAL MANUFACTURING INITIATIVE (PHARMI)