Biologic and Cell Solutions

Biologic and Cell Solutions

Without a targeted delivery system, the chances of biological drugs or cell therapies succeeding in clinical trials is decreased.

Achieve Success with Biologic Drugs and Cell Therapies

As the healthcare system moves away from treatments that focus on the symptoms of a disease and towards curing the disorder, new technologies are necessary to achieve success. Historically the pharmaceutical industry utilized small molecules and chemicals as active ingredients in drugs, but cures require more complex entities such as cell therapies, peptides and antibodies.

Thus, novel methods to deliver these therapies are needed. Without a targeted delivery system, the chances of biological drugs or cell therapies succeeding in clinical trials is decreased.

Core-Shell Spherification® (CSS) is a platform delivery technology that coats (encapsulates) biological therapies including cells, cell clusters, peptides, scaffolds and antibodies in a hydrogel. CSS is completely unique because it can utilize hydrogels that were once thought to be unavailable for encapsulation such as hyaluronic acid and PEG-based hydrogels. These hydrogels are already successfully used in areas including wound healing, dermal fillers, and cosmetic applications.

For the first time, a delivery system is now available for the newest classes of therapies that biotech companies are developing. CSS maintains and slowly releases the biological in a target location. Tunable control over formulations allows control of factors such as microbead size, release rates, and loading densities, providing a wealth of opportunity to create successful cell-based therapeutics.

Delivering Efficient Cell Therapies That Change Lives

Discover a whole new modality for the delivery of cell therapies. We have the first and only customizable platform for targeting cell therapies to increase their potency.

What We Do For Humans

By using better encapsulants, new opportunities unfold to treat specific diseases. CSS® enables cell therapies to function where they’ve never functioned before.

Ongoing or Completed U.S. Clinical Trials Using Stem Cells

as listed in the National Institutes of Health/FDA-approved database. (accessed Dec 2021)

…but few have made their way to the patient. The majority fail in Phase I and I/II. (Trounson A & McDonald C 2015; Stem Cell Therapies in Clinical Trials: Progress and Challenges; Cell Stem Cell 17, July 2015)

60%+ of FDA approved cell therapies focus on blood disorders

%

Many others focus on topical or superficial uses such as treating burns, wounds or for cosmetic applications. While an IV injection of cells may be successful to target blood diseases, obtaining a sufficient dosage at a targeted organ or tissue is still a major challenge. (US Food & Drug Administration, Aproved Celular and Gene Therapy Productsaccessed Dec 2021)

 

The Solution

We help our partners solve the following…

Brain

The loss of neurotransmitters can lead to diseases such as Parkinson’s disease. Cells that secrete these neurotransmitters can be placed in the brain with CSS.

Liver

The damaged liver from conditions such as liver failure can be replaced with new liver cells made from stem cells. Those cells need to engraft in the liver, but holding them in place while that happens has been a challenge that CSS solves.

Cancer

Peptides, antibodies and cell therapies are all being developed to treat cancer with the promise of more targeted therapies and fewer side effects. However, getting a sufficient dose to the site of the cancer has been a challenge for the field that CSS can solve.

GI

Crohn’s disease can be treated with antibodies to reduce inflammation, but without a delivery product like CSS, enough antibodies won’t get to the correct site.

Heart

Stem cells directed at heart damage following a heart attack need to be released at the heart with a delivery system like CSS.

Bones

Antibodies can be administered to block bone loss while stem cells can assist in repairing slow healing fractures, but how to get those cells to the right site and stay there is a problem that CSS can solve.

Hormone Disorders

Low hormone levels, such as the lack of insulin in type 1 diabetes, can be treated with cells that make the hormones (insulin), thus replacing daily injections with a single infusion of cells, but the cells need to be protected long-term from the immune system, which CSS can do.