Droplet ExteNsion (DEN) Technology for the Commercial Microarray Patch Manufacturing
MICRONEEDLE 2020
10th, Nov., 2020
RAPHAS Co., Ltd.Medical Business Division
Juyeop, SHIN
1. Introduction of RAPHAS & IP
2. Technology as DEN microarray
3. Business Model : Cosmetic, Medical Device & Medical field
4. Automatic In-line mass production for DEN
5. Production Yield and Capacity
6. Quality Control for Commercialization
CONTENTS
RAPHAS HQs & Research CenterPharmaceutical / Cosmetic GMP
HQs,Pharmaceutical GMP Factory in Seoul
1st GMP Factory in Cheonan, Korea
2nd GMP Factory in Shizuoka, Japan
Patent Status
Method & Equipment for DEN Microarray Core Technology
Raphas has 43 granted patents and Keep try to build evergreen strategy
Covered in USA, JAPAN, EU, CHINA and Korea(51 patents within Application)
Dispensing on the Adhesive Patch
Contacting Elongation And Drying
Separation of a couple patch
DEN MAP FABRICATION TIME
Dispensing on the Adhesive Patch
Contacting Elongation And Drying
Separation of a couple patch
1 min 3-4 min3 min 100-array based
1 process time needs just 8 minutes
One Layer DEN MAP
Double Layer DEN MAP
COMMERCIALIZATION PRODUCTS OF RAPHASAntiaging & Skin Care Products
PARTNERS
Trouble Cure PigmentationCare
Wrinkle care Dark Circle Care
Basement 2 hours (1-app.) After 4-weeks
0 Day 4 Day 7 Day
0 Week 4 Weeks
0 Week 4 Weeks
TOTAL ACCUMULATED SALES HISTORY of RAPHAS Microneedle Dermacosmatic Products
(2015- 2019)
0
200
400
600
800
1,000
1,200
1,400
1,600
1,800
2015 2016 2017 2018 2019
x 10
0000
00
ACROPASS ODM
MEDICAL PRODUCTS OF RAPHASFirst Dissolving MAP Medical Device
The rapas s ®
Psoriatic plaques improved significantly after 1 week of MAP application. The circle indicated by the white dotted line is a plaque treated with MAP. The modified Psoriasis Area Severity Index (mPASI) decreased from 7 to 1 in patient 1 (A and E), from 9 to 3 in patient 5 (B and F), from 5 to 0 in patient 6 (C and G) and from 6 to 2 in patient 9 (D and H). These patients were very satisfied with the additional application of the MAP application.
Clinical improvement of prurigo nodularis. Photograph of prurigo nodularis lesions before (A) and after (B) the application of dissolving MAP following topical steroids, and before (C) and after (D) the application of topical steroids alone (without the MN patch). The dissolving MAP side exhibited greater improvement with regards to size and height, compared to the control side.
Patch for absorption of transdermal medicine
Psoriasis Treatment
Prurigo nodularis Treatment
Eur J Dermatol 2018; 28(1): 71-7
J Dermatol. 2018 Jan;178(1):e24-e25
MEDICAL PRODUCTS OF RAPHASVaccine & Therapeutic area
Airway Hyper-Responsiveness
TuberculosisVaccine
COVID-19Vaccine
Hepatitis type BVaccine Immunotherapy
ACNE CareOTC
SCAR CareMedical device
Neutralization Antibody
7 weeks treatment
CAPACITY & YIELD OF RAPHAS MANUFACTURING SITE
12,000patches/single equipment/day
Automatic In-line Capacity (Present in 2020)
31,000patches/day
MT 20,000 Blister pack/day
Production Capacity of Individual Machine (Condition: day = 8hours, Yield 90%, Spot patch)
21,000patches/day
21,000 patches / line / day (8 hours)App. 420,000 patches / Line / Month (working day)
SPECIFICATION FOR QUALITY OF DEN MICROARRAY
Automatic Inspection of Appearance
Physical Strength of each Array/Needle
Microorganism ControlAerobic live & Specific M/O
(CFU/ml)
00.050.1
0.150.2
0.250.3
0.350.4
-0.04 0.01 0.06 0.11 0.16
Sta
ndar
d F
orce
(N
)
Travel from Touching Onwards (mm)
THERAPASS®
650um needle length
Microarray can puncture into skin and deliver drug into body. This image shows real skin puncture on our forearm by OCT.
MAKING CHANNEL BY MICRONEEDLE SKIN SURFACE
Stratum corium250um length of Microarray 600um length
of Microarray
Epidermal Dermal Junction
Epidermis
Dermis
These images are shown that skin penetrate depth depends on length of microarray.
SPECIFICATION FOR QUALITY OF DEN MICROARRAYSkin Puncture
SPECIFICATION FOR QUALITY OF DEN MICROARRAY
Basic Quality Control Points of Rapahs
Manufacturing is not the end, it's just the beginning. The ultimate goal is customer satisfaction.
We has Real Experiences form production to C/S managing of Microneedle commercial products.
“We innovate by starting with the customer and working backwards. That becomes the touchstone for how we invent”
We hope that many Microneedle inventors and developers will work together to help the market demand the productization and successful entry into the market.Thank you to the organizers of the Micronedle2020.