R&D Center

R&D / R&D Center

Biosolution R&D Center

As we enter the 21st century the average life span and health & welfare benefits have increased, therefore leading to the emerge of ‘Tissue Engineering and Regeneration’ as a medical field that can replace body part damage due to degenerative diseases, hereditary disorders, disorders, and accidents. In these situations, cell therapy products can provide a good answer for treatment of the damaged body through the improvement in tissue and cellular functions.

Cell therapy products of Biosolution Co., Ltd. are divided into two groups, one including products for skin diseases, and the second including products for articular cartilage diseases. KeraHeal, KeraHeal-Allo and PlusubGel are developed as skin therapeutics for burns and chronic incurable ulcers, while KeraHeal-II is developed for treatment of hypo-/hyper-pigmented disorders. Also, we developed several osteoarthritis therapeutics such as CartiLife, CartiLife-Allo and LipoCartigen for treatment of articular cartilage lesions caused by osteoarthritis or trauma.

PIPELINE

Product Contents Indications Discovery Preclinical
Trials
Clinical
Trials
Launch Current status
Skin
Disease
KeraHeal

KeraHeal

A Spray-Type Autologous Keratinocyte Therapy Product for Wounds

Product Name KeraHeal
Indications Deep 2nd degree burns that cover more than 30% of the total body surface area
3nd degree burns that cover more than 10% of the total body surface area
Dosage 1 mL cell suspension / 100~400 cm2
Storage Refrigerated at 2~8℃
Autologous
Keratinocytes
Burns(Severe) Market Authorization (2006)
Completed PMS (2013)
KeraHeal-Allo

KeraHeal-Allo

A Thermosensitive Hydrogel-Type Allogeneic
Keratinocyte Therapy Product

Product Name KeraHeal-Allo
Indications Promotes the re-epithelialization of deep 2nd degree burns
Dosage Apply 1 KeraHeal-Allo Syringe(2×107 cells / 1.5 mL)
once on 100 cm2 of burn wound
Storage Frozen at -15 to -25℃ in a Sealed Container
Shelf Life 18 months from production
Allogeneic
Keratinocytes
Burns(Deep 2nd degree) Market Authorization
(2015)
KeraHeal-II

KeraHeal-II

A Multi-Skin Cell Therapy Product containing Melanocytes

Indications Hypo-/hyper-pigmented skin disorder
Multi-Skin Cells Hypo-/Hyper
-Pigmentation
Completed Preclinical
Trials
PlusubGel

PlusubGel

A novel bioactive skin wound treatment product under development containing in vivo peptide that assist in the re-epithelialization and formation of granulation tissue through stem cell mobilization

Indications General skin wouands or chronic incurable ulcers
Peptide-Based Hydrogel
for Stem Cell Mobilization
Normal Skin Wounds,
Chronic Incurable Ulcers
Under Preclinical Trials
Osteoarthritis CartiLife

CartiLife

A scaffold-free bead-type autologous chondrocyte implantation for cartilage repair

Indications Articular cartilage lesions caused by osteoarthritis or trauma
Autologous Chondrocytes
with Extracellular Matrix
Osteoarthritis Planning on Marketing
in 2017
CartiLife-Allo

CartiLife-Allo

A scaffold-free bead-type allogeneic chondrocyte implantation for cartilage repair

Indications Articular cartilage lesions caused by osteoarthritis or trauma
Allogeneic Chondrocytes
with Extracellular Matrix
Osteoarthritis Under Preclinical Trials
LipoCartigen

LipoCartigen

An allogeneic adipose tissue-derived stem cell product genetically modified with non-viral vectors to enhance cartilage regeneration in ostearthritis

Indications Osteoarthritis
Gene-Transfected
Adipose Stem Cells
Osteoarthritis Under Large Animal-Based
Preclinical Trials
Human Tissue
Model
Human Tissue
Model
Skin, Cornea, Oral
Mucosa, Airway Mucosa,
Liver and Pancreas etc.
Alternative Test Methods Under Registration Process
for OECD Test Guidelines
Cosmeceutics STeM水 Cosmeceutic Ingredients
containing Stem Cell
Culture Media Extract
Anti-Wrinkle, Whitening,
Anti-Aging Effects etc.

Skin

What is Skin?

Skin, the largest organ of the body, plays a key role in protecting the body against pathogens and excessive water loss. It is comprised of the epidermis, dermis, and the subcutaneous layer underneath. More than 90% of the epidermis consists of keratinocytes, and the remaining area contains melanocytes, Langerhans cells etc.

The avascular epidermal layer, comprised mainly of keratinocytes, provides the barrier function of the skin. The epidermis is composed of 4 layers called the stratum corneum, granular cell layer, spinous cell layer and the basal cell layer. Epidermal stem cells are found in the basal cell layer and are responsible for the daily regeneration of the layers in the epidermis.

Different Types of Skin Diseases

Skin can be damaged by different types of skin diseases as shown below.

Burns

Burns are a type of injury caused on the skin or other tissues due to heat,
electricity, chemicals, friction, or radiation.

회사개요
Type Tissue Damage Appearance Symptoms Time to Heal Scars
1st Degree Burns Epidermis Rubefaction, Hyperemia Pain, Hot Flushes Several days None
2nd Degree Burns
(Superficial, Epithelial Layer)
Epidermis,
Superficial Dermis
Blisters, Rubefaction,
Swelling, Wet
Severe Pain, Hot Flushes,
Dullness in Sensibility
About 2 weeks In Some Cases
2nd Degree Burns
(Deep)
Deeper Dermis Blisters, Rubefaction,
Swelling, Wet, Blanched
Less Pain, Noticable
Dullness in Sensitivity
About 3 weeks Easily Scarred
3rd Degree Burns Entire Dermis,
Hypodermis
Necrosis, Carbonization,
Dried, Blanched
Painless, Loss in
Sensitivity
No Self-Healing Scarred
4도화상 Entire Dermis,
Hypodermal Fat,
Muscle, Bone
Necrosis, Carbonization,
Dried, Blanched
Painless, Loss in
Sensitivity
No Self-Healing,
Epitheleal Layer
does not Regenerate
Scarred

The fundamental goal of burn treatment is to prevent infections and regenerate the epithelial layers of the wounds at the earliest opportunity. Primarily used as therapeutics for burn treatment, skin substitutes were developed as an alternative to skin grafts, especially for burn patients; however, it is difficult to cover a large area of damaged skin using skin substitutes.

Intractable ulcer

Intractable ulcers are conditions caused by ulcerative damage on the epidermal and dermal region of the skin and occur in areas with insufficient blood flow. They are congenital or acquired through irritants, injury, and problems with auto-immunity and include conditions such as diabetic foot ulcers and pressure ulcers.

[Diabetic foot ulcer]

Intractable ulcers such as diabetic foot ulcers and pressure ulcers even result in hand or foot amputation and create profound psychological stress while interfering with daily lives. Therefore, there is a strong need for the development of new therapeutics.

[Pressure ulcer]

Vitiligo

Vitiligo is a chronic skin condition characterized by white spots forming on the skin due to a lack of melanin pigments. It presumedly occurs due to genetic, immune, and self-destructive melanocytes.

Along with vitiligo, achromic nevus, pityriasis alba and hypochromic scars trigger severe psychological stress and interfere with daily activities; development of new therapeutics is urgent.

[Vitiligo]

Development of the Next-Generation Therapeutics for Skin Conditions

Biosolution Co., Ltd. is developing safe and effective skin therapeutics such as highly concentrated skin stem cells, complex skin cells including melanic pigments, and wound healing peptides in the body that take part in stem cell mobilization.

Cartilage

Articular Cartilage and Osteoarthritis

Articular Cartilage is a tissue that acts as a cushion which neutralizes the physical load applied between the bones; it is composed of cells and extracellular matrices(Type II Collagen, Glycosaminoglycan(GAG)) that comprise less than only 10% of the volume of the articular cartilage.

As we age, the articular cartilage slowly wears out and progresses into degenerative arthritis. The self-regenerative capabilities of the cartilage are extremely limited; therefore a lack of treatment on damaged cartilage can lead to osteoarthritis, which in turn can cause a decrease in the quality of life due to pain and difficulty in movement.

Current Treatment Options for Damaged Articular Cartilage

There are medications or surgical procedures such as microfracture, osteochondral autograft or allografting being used, but these methods cannot fundamentally cure the damage in articular cartilage and show limitations when regenerating hyaline cartilage.
Microfracture/Drilling Osteochondral Graft/ Mosaicplasty Total Arthroplasty

A surgical method that drills small holes down to the subchondral bone for the stem cells and blood to be introduced from the bone marrow.
Can only be applied to small lesions and a drawback is that the cartilage regenerates itself into fibrous cartilage.


A method that transplants normal cartilage (cartilage that does not take weight load) or allogeneic cartilage into the lesion.
The lack of donor tissue limits the transplant only to smaller lesions, and there are chances of immune responses and infections when using allogeneic tissue.


A method that replaces the joint surface with a metallic artificial joint. It limits the range of movement in the joint after surgery and can induce osteolysis to its neighboring bone tissue.
Although the patient has to undergo trouble of another surgery after around 10 years, this is the only surgical process available for extensive terminal osteoarthritis.

Reference

1), 2), 4): “Overview of Treatment Options for Articular Cartilage Repair: Past Present & Future” (May 15, 2009 by Ken Zaslav, M.D.)M
3): J Bone Joint Surg Am. 2004;86:65-72.

Cell Therapeutics, the Next-Generation Biopharmaceuticals

To improve on the weaknesses of existing therapeutics, companies are developing cell therapeutics, the next-gen biopharmaceuticals using cell culture technology. However, a product that is able to regenerate cartilage that can carry out the functions of the articular cartilage and have the ability to regenerate hyaline cartilage in an arthritis environment is desperate both in and out of the country.

Biosolution Co., Ltd. does more than the 1st-gen cell technology that simply proliferates the cells; we use a next-gen cell application technology to develop a small spherical cartilage called CartiLife, which uses scaffold-free tissue engineering technology to regenerate articular cartilage, and to develop LipoCartigen which is made through the transfection of genes that promote cartilage differentiation.

Alternatives to Animal Testing

Alternatives to Animal Testing are new or amended test methods that have a basis on the 3R rule which stands for the Refinement by minimizing the pain inflicted on experimental animals, Reduction of the number of experimental animals, and the Replacement by using lower forms of life or cells.

Using human tissue models as alternatives to animal testing will improve on the errors within previous animal test results to predict a more accurate human response and is under vigorous research as an alternative due to the prohibition of animal testing.

Animal testing on cosmetics is prohibited in the EU, thereby advising alternative test methods. This movement of prohibiting animal testing is expanding over to medicine, medical devices, chemical substances etc.

The Cosmetics Act in Korea has also been amended to include restrictions on animal testing in the year 2015.