JBP Curacen Inj.

JBP Curacen Inj.

Product Information

CURACEN Inj.

Etymology- Cure + Placenta

Product Name

Ingredient

Human Placental Extract (2 mL)

1 mL of Soln. containing 1 mL of Human

Placenta Extract (as soluble substance 50mg)

JBP Curacen Inj.

Product Information

Indication • Improve symptoms of Climacteric Disorder

Use & Dose

Indolent Agent

Raw material/

Technology

• 1amp.(2mL), 3 times in a week for 2 weeks

• Injection by Subcutaneously

• Benzyl alcohol (0.03mL/amp.)

• Ensuring pain-reduce

• Secure the long shelf-life as 2 years

• 株式會社日本生物製劑

(Japan BioProducts Co., Ltd.)

JBP Curacen Inj.

Clinical Study

Efficacy and Safety Profile of Curacen to Climacteric Disorder (薬理と臨床 2005)

Excellent: Remedy rate-over 70 %

Effective: Remedy rate-50 % ~ 70 %

Slight effective: Remedy rate- 30 % ~ 50 %

Ineffective: Remedy rate- 0 % ~ 30 %

Exacerbation: Remedy rate- ~ 0 %

41 patients in Climacteric Disorder

Inject 3 times/week for 2 weeks

Statistical significant (p < 0.01)

High Effectiveness as over 90%

JBP Curacen Inj.

Clinical Study

Efficacy and safety of Curacen to alleviate climacteric symptoms Department of Obstetrics and Gynecology, Seoul National University Hospital, Seoul, Korea, 2006

Figure 1. Comparison of the baseline and mean values at different times of the Kupperman Index (KI) of the women treated with the placebo and plamon. In both groups, the final value was significantly different from baseline; nonetheless, the index was significantly lower in the plamon group in comparison with placebo (p=0.012).

108 patients in Climacteric Disorder

Prospective, Random, Double-Blind

Inject 3 times/week for 4 weeks

Measuring with KMI (Kupperman Index)

Statistical significant (p < 0.012)

JBP Curacen Inj.

Beauty Applications

Cell Proliferation

Cell Reproduction

Collagen Generation

Anti Oxidation

Rejuvenating

Whitening

Anti aging

Lifting

Mesotherapy

JBP Curacen Inj.

Unique Characteristics

Safety 1

2

3

4

Collect placenta and Manufacture raw material under Japanese Pharmaceutical affairs law

Raw material processing at JBP who manufactures placenta inj. for 40 years

Credibility

Validation

Tracking

Execute validation in all processes for preventing contamination by microbe

Establish tracking system for post checking

JBP Curacen Inj.

Quality & Safety

DS

PST

BS

VFA

FPS

Final Product

Sterilization

Virus Free Assurance

Bulk Sterilization

Placenta Selection

Donor Screening

JBP Curacen Inj.

Donor Conditions

Donor must be not infected by any virus including BSE 1

Exclude donor who has infectious disease like syphilis and chlamydia, or hepatism and malignant tumor 2

Explain purpose of use to donor, and provide a written consent 3

Retain record of collection agency, date and ID No. and maintain manufacture data, distribution data and injection record

4

JBP Curacen Inj.

Donor Screening

Under Japan MOHLW

Strict Regulation “Biological Origin”

Maternity consent Checking results

Contract with Hospitals Maternity Screening

Collection of Placenta (only normal childbirth)

Check virus infection & BSE

Prepare written consent

JBP Curacen Inj.

Placenta Selection Test

Basic test

Appearance, Color, Solidity,

Foreign matter

Quantitative test

NAT Test

HBV HCV HIV

Selection

Only approved placenta

should be delivered to

JBP Plant

Selection Test under Validation

JBP Curacen Inj.

Bulk Sterilization (1)

Processing of

Placenta

Evaporation of

HCl

(Vacuum heating)

• Separate villus tissue / Wash & eliminate blood

• 80°C~100°C over 100 hours

HCl

Hydrolysis

• 101°C for 3 hours • All proteins hydrolyzed • Negative sign for protein reaction test • Content an effective substance due to control of hydrolysis

JBP Curacen Inj.

Bulk Sterilization (2)

Processing of

Raw material

Final sterile

Process

• Autoclave 121°C for 20 minutes • Sterile-Membrane Filter

• Ion exchange resin, Filtration • Neutralization (add NaOH, pH 6.8~7.2) • Add distilled water & benzyl alcohol for controlling volume

Execute validation in all sterile processes

JBP Curacen Inj.

Virus Free Assurance

• Content test

• Execute validation for

checking

virus contamination

• HBV, HCV

• HIV, HTLV

• Parbovirus B19

Provide Production No.

Quality test

Validation

Virus negative Test

JBP Curacen Inj.

Final Product Sterilization

Import

Inspection

Sterility &

Manufacture

Quality

Check

Identification

Sterile test

Histamine test

Antigenic test

Safety test

Content test

Sterile filtration

Filling ampoule

Sterilization

(autoclave121°,30mn.)

Identification

Sterile test

Histamine test

Antigenic test

Safety test

Content test

Provide Tracking No.

JBP Curacen Inj.

Tracking System (1) Curacen is controlled safely from collection of placenta and processing to patient chart

Keep all records completely

Tracking system can trace even placenta as raw material

JBP Curacen Inj.

Tracking System (2)

Quality test

(Test No.)

Incoming test

(Test No.)

Processing/Sterilization

(Raw material No.)

Japan

Collect/Convey Placenta

(Identification No.) • Hospital name, Doctor’s name, Contract, Collection date • Written consent, Chart, ID No.

• Incoming date, Tester’s name • Check each test, Provide test No. • Discard inadequate placenta (Provide confirmation)

• Manufacture raw material following the proper process • In-process test, Validation, ID No.

• Quality test, Record • Tester’s name, Test date, Test No.

JBP Curacen Inj.

Tracking System (3)

Import/Quality test (Quality control No.)

Manufacture product (Batch No.)

Quality test (Tracking No.)

Inject (Injection record)

Korea • Import, Quality test • Record data, Tester’s name, Test date

• Production, Sterilization • Provide Batch No.

• Quality test • Tester’s name, Test date, Test No. • Provide Tracking No.

• Inject to patient • Attach batch No. on the chart • Completion of Tracking system

JBP Curacen Inj.

Thank You!