ECT Platform
Encapsulated Cell Technology (ECT) is a unique biotechnical implant system developed at Neurotech Pharmaceuticals. ECT implants are capable of continuously producing recombinant biotherapeutics for up to two years in the eye.
Biology
The basis of the ECT platform is the NTC-200 cell line, a naturally immortalized retinal pigmented epithelial cell line. NTC-200 has not been virally transformed and is not oncogenic in nature. NTC-200 cells were initially screened from many other cell types as being remarkably hardy: the cells thrive under low oxygen and low nutrient conditions, while being amenable to genetic manipulations under stringent selection methods. These NTC-200 cells can be traced back to primary tissue culture cell isolation, and have a documented history of expansion in growth media since 1995. Recombinant cell lines derived from transfected NTC-200 cells can secrete all modern classes of biotherapeutics: cytokines, monoclonal antibodies, antibody Fabs, single-chain Fv and other alternative scaffolds. Recombinant protein production levels of NTC-200 cell lines rival CHO manufacturing cell lines, attaining secretion levels up to 50 picogram/cell/day of recombinant protein. Therapeutic NTC-200 derived cell lines have been master banked under GMP conditions and have been tested to be free of known viral and bacterial pathogens. Cell lines producing CNTF, Renexus® (NT-501), have won IND approval in the US by the FDA for clinical trials.
Engineering
ECT devices are fabricated from medical-grade plastics and consist of a semi-permeable polysulfone exterior capsule and an internal scaffolding made of polyethyleneteraphtalate yarn. The finished devices allow prolific cell growth and protein production within the hollow capsule. Watch Video The semi-permeability of the capsule allows nutrients in the vitreous to freely diffuse inward, and allows the recombinant biotherapeutic to freely diffuse outward. Devices are engineered and assembled according to specifications that defines porosity and controls drug diffusion. Different device geometries and nutrient conditioning are explored for each clinical cell line produced, and the configuration best addressing the target disease indication are tested in models for bio-compatibility. Simultaneously, the capsule is a barrier to the host cellular immune system and allows long term viability in an implanted setting. Watch Video
Manufacturing
Neurotech Pharmaceutical's manufacturing operations in Cumberland, RI, are held within a 26,000 square foot facility and operates under GMP guidelines. The ECT manufacturing facility is designed for Phase 3 / commercial launch, with the capacity of producing at least 150,000 ECT units a year. Filling of cells into ECT devices is tightly controlled by proprietary semi-automated liquid injectors and performed under cGMP clean room environments. Finished implants are held in nutrient media containers and monitored under strict cGMP Quality guidelines. ECT implants are then shipped to trained ophthalmic surgeons for implantation into patients.
Clinical Trials
The 20 minute outpatient surgical procedure is simple: a single incision, insertion, and suture-anchoring of the device. Watch Video. The ECT implant does not cross the visual axis, and does not impair vision. The implant cannot be visualized in the absence of dilation. ECT implants have demonstrated an excellent safety record in over 250 patients and 20 medical centers. Neurotech has deep connections within the ophthalmic community. Neurotech has ongoing collaborations with a network of renown ophthalmic surgeons, located in private clinics and medical academic centers. Neurotech actively participates in research investigator initiated trials that apply next-generation analytical instruments to measure the effects of ECT treatment. New methodologies currently being utilized to evaluate ECT efficacy include adaptive optics (AOSLO), microperimetry, and sd-OCT. Neurotech collaborates with the National Eye Institute on trials related to retinal diseases such as retinitis pigmentosa, dry AMD and achromatopsia.