Sign up for Our Newsletter

Sign up below to get new article notifications, important news & exclusive deals from Keeler.

Opticyte

Opticyte: Better Scientific Process, Better Outcomes

Click to Play Audio Version of this Content
Voiced by Amazon Polly

The following article is a guest post by CEO and founder of Merakris Therapeutics, Chris Broderick, RAC, CTBS:


As the CEO and founder of Merakris Therapeutics, I was extremely proud to partner with Keeler to help advance our missions. Their forward-thinking culture aligned perfectly with our values, and they have proven to be an ideal partner for our Opticyte Amniotic Ocular MatrixRM product line. This state-of-the-art biological barrier graft protects damaged eye surfaces during healing in patients who may suffer from corneal defects, such as dry eye disease.

At Merakris Therapeutics, we work to produce commercially-scalable biotherapeutic technologies derived from stem cells. These innovative solutions are designed to promote homeostasis in damaged tissue. 

Today, our OpticyteRM has been used in the north of 30,000 implants and the success of Opticyte can be attributed to our unwavering dedication to product integrity, quality production, and better science. Let's take a closer look at why our better scientific process is driving better outcomes.

Your Patient's Safety Should Come First 

Across the industry, there is a misconception that cryogenic methods are superior to dehydration methods. However, this isn't true, especially when it comes to ocular products. During cryopreservation, some type of cryoprotectant must be added; and usually, this is dimethyl sulfoxide (DMSO). Once added to the media, DMSO prevents the formation of intracellular and extracellular crystals during the freezing process. 

Although DMSO has been declared non-toxic and safe to stem cells, several reports have been submitted from transplant centers on the serious side effects in patients because of the DMSO toxicity.

Based on Berz, et. al. 2007, about half of all transplant cases involve mild side effects such as nausea, vomiting, and abdominal cramps. However, more serious side effects have also been observed. For example, patients with cardiovascular, respiratory, and renal systems therapies and surgeries have even suffered some fatalities. 

Another common cryoprotectant used is glycerol, and like DMSO, it can be toxic depending on the concentration. Unfortunately, we don't always know whether a manufacturer is using cryopreservation chemicals because the manufacturing is usually done in a proprietary manner. 

OpticyteRM Is the Safer Solution

Due to the known propensity for toxicity associated with glycerol and DMSO, we innovated a dehydration process to create our Opticyte Amniotic Ocular MatrixRM. Our sophisticated and delicate dehydration process is designed to retain extracellular matrix properties and structures. Unlike many cryopreservation methods, Opticyte is manufactured without harsh chemical reagents that can irritate the eye when placed in the corneal bed. With Opticyte Amniotic Ocular Matrix, we strike the perfect balance between efficacy and safety. 

OpticyteRM Is Engineered for Ease of Use 

When we created OpticyteRM, we set out to challenge the status quo to produce a superior product and the best way to achieve this goal is by utilizing a superior dehydration process. Other companies that offer discs use a dehydration process that involves the use of a plate to — not necessarily cook — apply heat to expedite the dehydration. 

However, those products have not been analyzed for protein denaturation. At Merakris Therapeutics, our dehydration process involves the gentle use of air to dry the membrane out and is focused on the maximum preservation of proteins.

Our process also results in the creation of a product that is extremely easy to use and readily available. We wanted to provide tissue in the form that is the easiest for the customer to store for the longest amount of time and use on-demand. 

The whole idea behind dehydrated membrane is it can be stored easier and ready to go when you need it. You'll never need to purchase special equipment to store Opticyte, which can negate a hefty capital expense. There is no need to rehydrate Opticyte before placing or even bring it to room temperature. Instead, you simply pull Opticyte out and use it, which can save you and your staff time. 

No Chemical Cross-Linking Reduces Irritation & Increase Comfort and Effectiveness

With our DermacyteRM product, we use glutaraldehyde to cross-link and chemically treat the tissue. This works well for the Dermacyte product because it's designed for wound care. However, due to the sensitivity of the eye, we worked diligently to use no cross-linking chemical in the manufacturing and engineering process. The result is an Opticyte product that is extremely gentle and doesn't result in irritation to the patient's eye. 

Another innovation we used in our manufacturing process is with irradiation. Some products tend to get cooked a bit more than necessary, which is a common indicator of the tissues being irradiated at twice the radiation level. At this level — 25 kilogrades— the tissue will begin to take on a yellowish tint, which isn't ideal for ocular applications. 

However, irradiating at this level causes more than cosmetic issues. It has been shown to break down the proteins. The higher the radiation, the more likely denaturation will occur. To avoid this phenomenon, we are at around 12 kilogrades of radiation, which allows us to protect key proteins and deliver a more sensitive, delicate product that performs. 

How Does OpticyteRM Compare to Fresh-Frozen Products?

According to research published online on May 6, 2019, titled "Comparison of cytokine expression and ultrastructural alterations in fresh-frozen and dried electron beam irradiated human amniotic membrane and chorion," the dehydration method is more effective than freezing in the preservation of Epidermal Growth Factor (EGF), which plays a critical role in healing wounds by stimulating dermal and epidermal regeneration.

The study looked closely at and compared the effects of fresh-freezing and drying on the human amniotic membrane (HAM) and amnion/chorion membrane (HACM) in terms of structural and histological characteristics as well as cytokine levels. In addition to the dehydration method being more effective than freezing in the preservation of EGF, the study also discovered there is more EGF in the amnion than chorion. 

This is critical and speaks directly to the effectiveness of Opticyte's method of production and why we chose our gentle method of dehydration over freezing. Because we use a gentle dehydration method, we are able to preserve more EGF, which plays a vital role in re-epithelialization. EGF is a highly potent mitogen for epithelial cell growth, helps promote wound healing, and is theorized to play a role in supporting corneal epithelial cell expansion after amniotic membrane transplantation. 

OpticyteRM Boasts Versatile Orientation 

Aside from our preservation technique, another key benefit of OpticyteRM is versatility in up or down placement. There are two different sides to amniotic tissue: 

  • An epithelial cell lining that is representative of the inner wall of the amniotic membrane.
  • The exterior is the in utero exterior side that faces out from amniotic fluid. 

We have discovered that when it comes into contact with the natural hydration of the eye, Opticyte will do its job of supporting the healing process — regardless of orientation. 

This means whether you use an up or down placement strategy, the exchange of fluids around the extracellular matrix proteins still happens. We have seen no evidence that suggests there is a directional application that gets better results one way or another. On the contrary, physicians have reported back they have experienced comparable results on either side. 

Why Is OpticyteRM a Better Product?

It's all about the process. There are very few things we can do inside the current regulatory framework that will concentrate the natural, inherent components of the tissue. 

However, we can optimize the process from recovery to the purification of the membrane for a clean product. Our process yields a product that remains stable and usable for up to five years. While other competing products may require you to wait, bring to room temperature, and then use; OpticyteRM was designed through a better process for you to use more easily. 

Other manufacturers either apply significant heat or freeze it at -80 with no cryoprotectant. Heat has historically led to denaturation; and freezing is cumbersome, expensive to ship, and can even require you to purchase special equipment to preserve it. If you have frozen membranes and they fall out of the required range, they are unusable. 

We chose to take the best of both worlds and go down the middle of the road. We perfected a process of dehydration that involves using an ambient room temperature — like a cool fan blowing system — to strategically dry the disc and minimize it. As a bonus, we cut down on irradiation and the results are in the product and the user experience.

About the Author Chris Broderick, RAC, CTBS

Mr. Broderick is CEO and founder of Merakris Therapeutics Inc., and has been instrumental at leading Merakris’ through the development of its core quality system, intellectual property strategy, investigational new drug filing, and implementation of advanced information technology systems. He previously led a startup tissue banking operation, including raising over $1.5M in equity financing, for the manufacturing of human placental- and cadaveric-derived allografts technologies. He received a Bachelor of Science in Business Administration from Appalachian State University and has spent 15 years working for product and service organizations, including manufacturing operations in human tissue-derived bioprocessing. Mr. Broderick is currently pursuing a Master of Science in biomanufacturing at North Carolina State University’s Golden Leaf Biomanufacturing Training and Education Center (BTEC), the world’s largest commercial-scale biopharmaceutical training facility, with a research thesis concentration in cGMP optimization of targeted biomolecule purification from amniotic tissue.

follow me on: