The INTACT Filler

MEDIntegrityTM
201 Housatonic Avenue
New Milford, CT 06776
860.350.1900
MEDInstill Bridges Physics and Microbiology to Engineer the
Compliance of Complete Sterile Transfer Systems
Turn-Key MFG Lines
2013-14
Regulatory
Dispensing
Filling
INTACT Fill for Topical
Non-Preserved at Encube
2011
2007-09
2001-03
1987
STERILITY
&
COMPLIANCE
Licenses INTACT
Closed Vial
Licenses
INTACT Valve
MEDInstill &
founded by
Daniel Py, MD, ScD
INTACT Valve
“New Standard”
for Multi-Dose Dairy
Non-Refrigerated
EMA Vaccine Approval
GSK Synflorix
DMF Registered at FDA
Qualification
PATH Validation for
• WHO
• B. Gates Foundation
• Homeland Security
INTACT DMF
For DSL Fast-Track
2 LACF
Acceptances
Over 400 patents granted
02
MEDInstill Technology Platforms
* = Pall Exclusive
Intact™
Technologies
(Platforms)
Intact™
Modular Filler
Intact™
Products
& Services
+
Filling
Mini Intact™
Modular Filler
*
In-line
Sterilization
+
Container
sterilization
Dispensing
Devices
*
+
Universal
Closure
Connectors
DROC
Multiple Dose
Syringe
*
SCOT
*
Baby bottle
Eye Dropper
Pouch
*
Markets
• Pharma/Biotech
• Nutrition & Beverages
• Cosmetics
• Compounding
Home Care
Hospitals
• Pharma/Biotech
• Nutrition & Beverages
• Cosmetics
• Pharma/Biotech
• Nutrition & Beverages
• Cosmetics
• Home
• Hospitals
*Device may be single-dose or multi-dose
*
• Pharma/Biotech
• Nutrition & Beverages
• Cosmetics
• Home
• Hospitals
Public Service Announcement
MEDInstill has licensed to Pall the SCOT Multi-Use Connector
Samples available now
MEDInstill and Pall own the Joint Venture, MEDIntegrity to
commercialize the INTACT CNC Sterile Filler
Schedule trials now
EMA Approval of 1st Generation INTACT (DMF filed at FDA) (Parenteral)
FDA Submission this year (Parenteral)
TM
MEDIntegrity Platform is the Intact CNC Filler
The IntactTM CNC is a scalable platform for the sterile fill of high value
biopharmaceutical, cell therapy and pharmaceutical fluids utilizing a disposable
fully closed needle and closed septum format in controlled non-classified
manufacturing space.
CNC = Controlled-Non-Classified environment
• Lock-in / Lock-out
• Basic Gowning (Hairnet, gloves, lab coat)
05
INTACT Filler Enables Protein Therapeutic
Disposable Platform to be Vial-to-Vial
INTACT CNC
Sterile Filler
Implementation Strategy for Complete Single Use Processing for Biologics, David Pollard, Merck &
Co. Inc., IBC Single-Use Conference, 2011
INTACT Filler Enables Cell Therapy
Disposable Platforms to be Vial-to-Vial
Mini-INTACT
Sterile Filler
SCOT RSS
Multi-Use Sterile Connector
INTACT CNC
Sterile Filler
The INTACT CNC Filler
Primary advantages: (Value Proposition)
Highest safety
100% closed systems
Capital avoidance
Reduce facility requirements by hundred million(s) $
Reduce line requirements by tens of millions $
Time to market
Reduce build-to-commission time by at least 2 years
Reduced operating costs
At least $4-6M/yr per line
Process flexibility
One machine for multiple products, volumes, devices
Primary Uses:
Repetitive large & small scale sterile fill in CNC environment
INTACT CNC Single Module
CNC = Controlled Non-Classified, (ISO 8 or Class 100,000)
Loading Plate for
INTACTTM Pouches, Vials or
Multi-Dose Vials
Montrac runs through the
INTACT CNC Filling Modules(S)
TM
The Intact CNC is a Breakthrough Sterile Fill Technology with
Validated Performance
INTACT CNC Fill is validated to meet high performance thresholds:
• Robust microbial integrity / Complete exclusion of bioburden
• Validation of sterile transfer at 6 log challenge
• >165,000 sterile media fills at MEDInstill in 2013
• > 90,000 planned this year at customer sites
• Consolidating kit & device validation package per CURRENT industry standards
E.P.3.1.9
JP 59
USP 88 Class VI
Cytotox ISO 10993
Hemolysis ISO 1099
USP 381
USP661
USP 788
Pyrogen
LAL/Endotoxin
L/E (per BPSA)
ADCF Certifications
010
The INTACT Filler “Kit” is
Multi-Use and Disposable
SCOT
Connector
ISCON
Needle
(To Fill Reservoir
or surge vessel)
(To filled Device)
INTACT
Fill Head
ISCON
Needles
(Caps On)
INTACT Devices from MEDInstill
INTACT Value Proposition
Highest Safety
INTACT Provides Highest Safety at Lowest Cost
Class 100
12G
12G
12G
Class 100,000
12G
385,000X Safety Increase
CapEx ($60M - $150M)
For 2ml Vial
ISO 5
CR = 5/10,000/1hr
Total System
Exposure (mm2)
Aseptic
Open 12g Needle +
2ml Open Vial
Aseptic Cannula +
Vial + Stopper
Aseptic Cannula +
Closed Vial
Closed Needle +
Closed Vial
173
32
Safety Index
1/Total Exposure (mm2)
(Needle + Vial + Stopper)
4.5 x 10-4
CR = 1/10,000/1hr
ISO 7
Aseptic
Open 12g Needle +
2ml Closed Vial
Clean Fill,
Preserved
INTACT CNC
Closed 12g ISCON +
2ml Closed Vial
CR = 1/10,000,000/1hr
ISO 8
6 x10-3
3 x10-2
2 x103
Safety Index (2ml Vial)
Contamination Risk (CR) is function of:
Surface exposure
Exposure duration
INTACT Provides Unmatched Safety
for Preservative-Free Multi-Dose Devices
The INTACT dispensing valve “utilizes an anti-contamination visco-elastic valve
which uses a stress differential effect to force out any residue and prevent microbial
ingress.” (PATH, Sept. 30, 2013. “Review of multi-dose primary packaging and
delivery systems for vaccines without preservative.”)
The INTACT Anti-Contamination Valve
For Multi-Dose Dispensing
PATH = Program for the Appropriate Technology in Health
Validation of Safety
• Link to microbial validation data
• Link to particle validation data
• Link to L/E data
INTACT Value Proposition
Lowest Capital Requirements
Scenario 1: 6ml Devices / 3ml fill
Assumptions
Sales = 20,000,000 vials per year
Depreciation capital / yr
Asceptic in Existing Facility not fully depreciatedShifts
INTACT is 3 Module
Hr. per shift
Total hr. / day
Time to Market (Mo.) Aseptic INTACT
FTE / Shift
18
2
Days / Yr
Source/deliver filler
4
1
$ FTE / Day
Install/Qualify filler
12
9
Direct labor / yr
$
Validate filler
TOTAL (Mo) 34
12
Devices/min
Theoretic output / yr
Uptime
Downtime
Actual output / yr
Prep space for Fill Hardware (ft2)
(Class 10000 for Aseptic, CNC for
INTACT Value Concepts
INTACT)
Reduced capital
Prep space cost/ft2
Reduced time to market
Space for Fill Hardware (ft2)
Reduced risk of contamination
(Class 100 for Aseptic, CNC for INTACT)
Reduced labor
Cost fill hardware space (ft2)
Reduced HVAC hardware
Total cost space for filler
Increase facility effiency (Reduced downtime)
Depreciation filler space / yr
Cost HVAC / yr
Eliminate SIP / CIP
Filler hardware
Eliminate HVAC validation
Depreciation filler/yr
Reduce costs
SIP/CIP Hardware Plumbing cost
Space for SIP/CIP (ft2)
Cost SIP/CIP space (ft2)
Total cost SIP/SIP space
Depreciation SIP/CIP space
Cost SIP/CIP Validation / yr
QA/QC/Maintenance SIP/CIP /yr
Waste water treatment structure
Space for WIFI (ft2)
Total cost WIFI space
Depreciation WIFI space (ft2)
WIFI hardware
Depreciation WIFI hardware
QA/QC/Maintenance WIFI /yr
Total /Yr
Distilling the Value
Proposition
Aseptic
0.1
2
8
16
4
250
$1,000
2,000,000.00
200
48,000,000
49%
51%
23,298,000
INTACT
Delta Cap
0.1
1
8
8
2
250
$1,000
$500,000
240
28,800,000
82%
18%
23,726,400
1,000
1,000
$1,300
$300
2,000
1,000
Delta
Ops/yr
$1,500,000
$1,600
$300
$4,500,000
$600,000 $3,900,000
$450,000
$60,000
$390,000
$300,000
$0
$300,000
$9,000,000 $6,000,000 $3,000,000
$1,800,000 $1,200,000
$600,000
$3,000,000
0
1,000
0
$300
$300
$3,300,000
$0 $3,300,000
$330,000
$0
$330,000
$500,000
$0
$500,000
$200,000
$0
$200,000
$800,000
$0
$800,000
1000
0
$300,000
$0
$300,000
$30,000
$0
$30,000
$3,000,000
$0 $3,000,000
$600,000
$0
$600,000
$200,000
$0
$200,000
Total /Yr $14,300,000 $4,650,000
Validation of Cost Models
• Link to cost models
• Link to case studies
INTACT Value Proposition
Fastest Time to Market
Time to Market (Mo.)
Aseptic INTACT
Source/deliver filler
18
2
Install/Qualify filler
4
1
Validate filler
12
9
34
12
TOTAL (Mo)
Confidential
INTACT Fill Reduces Time to Market
Design INTACT Filler
Build & Deliver
<2 months
(See case study)
Design INTACT Facility
(Existing CNC)
Install & SAT
1 Week
(See Case Study)
INTACT Fill Reduces Time to Market
Remote Location: Design, Build, Install & SAT
A MEDInstill Placement
Confidential
Stainless Steel
Reservoir
Conveyor Open for the
Reservoir Passage
Peristaltic
Pumps on
INTACT Kits
Stainless Steel
Reservoir
Confidential
The 1st Non-Preserved Dermatologic Cream
Manufacturing in the World
• Delivered in less than 2 months from PO
• Installation & SAT less than 1 week
• At a fraction of an aseptic line cost
Confidential
INTACT Value Proposition
Lowest Cost of Goods
Cost Savings From Class “C” to CNC
Savings per year in bulk drug substance facility with 180 operators, 15,000 ft2 class ’C’ space versus controlled not
classified (CNC), air changes from 30 to 10 per hour and humidity ranges from 45% to 60%.
Source: Challenging the Cleanroom Paradigm for Biopharmaceutical Manufacturing of Bulk Drug Substances. Aug 1, 2011 / BioPharm International,
Volume 24, Issue 7. By: Simon Chalk, Scott Probst, Paul Gil, Tim Palberg, Matt Kennedy, Joe Rogalewicz, Jeff Johnson, Ken Green
Cost Savings of INTACT Devices
Eliminates all labor, capital requirements, process validation,
utilities and risk associated with traditional vial (or device):
•
•
•
•
•
•
•
Vial (or device) sterilization
WIFI Rinse
Hot air tunnel
Stopper sterilization
Siliconization
Stopper seal
Stopper crimping
Customer Study
1 Module INTACT Filler in Existing Building
CONVENTIONAL DEDICATED VIAL
FILLING SYSTEM IN AN ISOLATOR
CONVENTIONAL SYRINGE
FILLING SYSTEM IN AN
ISOLATOR
Capex
$3M
$3.8M
$5M
Throughput /
minute
Up to 120
(10ml Vials)
Up to 60
(1 to 3ml Syringe)
Up to 40
(1 to 10 ml Vials &
Syringes)
Uptime
40%
40%
85%
Annual Volume /
shift
(250 days)
6M
5M
8M
CNC Pilot Filler
Customer Study
3 Module INTACT Filler in a Existing Building
CONVENTIONAL Aseptic
Filler
CNC 3-Module Filler
Capex +
Peripherals
$10M
$10M
Throughput /
minute
Up to 500
(10ml Vials)
Up to 480
(1 to 10 ml Vials &
Syringes)
Uptime
40%
80%
Annual Volume /
shift
(250 days)
25M
49M
Customer Study
3 Module INTACT Filler in a New Building
CONVENTIONAL Aseptic
Filler
CNC 3-Module Filler
Capex +
Peripherals
$10M
$10M
Capex Suite
$8M
$2M
Capex Building
$60M
$5M
Throughput /
minute
Up to 500
(10ml Vials)
Up to 480
(1 to 10 ml Vials &
Syringes)
Uptime
40%
80%
Annual Volume /
shift
(250 days)
25M
49M
Validation of Cost Models
• Link to cost models & case studies
INTACT Value Proposition
Unmatched Flexibility
Same Filler for Multiple MEDInstill Devices
IntactTM Filling Head (“Kit”)
( ISCON , Tubing, SCOT Connector)
INTACT Bottle
INTACT Pouches
INTACT Multi-Dose
INTACT Vials
The INTACT filler is quickly converted from one product to another and
one INTACT device to another.
The INTACT Multi-Dose device adds exponential value
The INTACT Filler Series
CNC 3 module
in double line
filler
Generation of Filler
CNC 3 module
Filler
CNC 1 module
Filler
CNC Mini-Filler
4
3
Large Commercial
Volumes
2
Medium to Large
Commercial
Volumes
1
Validation, Pilot Plant, R&D,
Launch & Medium Volumes
+
R&D, Qualification
++++
Volume / year
The INTACT Fill Technology is Scalable
CNC Pilot
Filler
CNC Filler /
3 Modules
CNC Filler /
3 Modules
CNC Filler /
3 Modules
CNC Filler /
3 Modules
Containers / Vehicle
4
4
12
32
40
Device per Line
4
4
6
8
10
Number of Rows
1
1
2
4
4
Production Rate / min
40
80
240
640
800
Production Rate / hour
2,400
4,800
14,400
38,400
48,000
4
8
24
65
82
Annual Production Rate /
year/shift (M)
Note: 10ml Device Assumption
Fill Kits
Installation in <10’
INTACT ISCON Needle
Ready to be uncapped by 1st
vehicle in closed canopy
Multiple MEDInstill INTACT Devices in Same Filler
Thank you.