Manufacturing Program
Living Immune Cell
GMP Manufacturing
Mirror Biologics operates a FDA-registered blood donor center compliant with both 21 CFR 600 blood regulations and 21 CFR 1271 tissue regulations. The facility contains a blood donor suite and class 100 clean room cell processing suite for collection and purification of blood components from whole blood and leukapheresis for further manufacturing use. Source blood is further processed in our cell manufacturing facilities built and operated in compliance with Good Manufacturing Practices (GMP). These GMP facilities perform aseptic cell purification, expansion and differentiation processes, cell harvesting, washing and aliquoting, formulation and filling, liquid nitrogen storage, vein-to-vein bar-code tracking of all supplies and components, cold chain distribution control to points-of-care around the world. Our GMP facility includes class 100,000, class 10,000 and class 100 clean room facilities, separate environmentally controlled quarantine and release warehouse facilities, centralized environmental monitoring and with systems for control of equipment, supplies, reagents and personnel. All systems and processes operate according to written instructions with regular internal and external audits. Our Quality Management Team, consisting of the heads of manufacturing, quality control (QC) and quality assurance (QA) assure quality by design, conduct root cause investigations and manage change control with systems for continuous improvement to provide consistent safe and functional products. Our production processes have been optimized and in-process QC and QA controls incorporated such that blood from different donors results in a product that consistently meets pre-defined release criteria for identity, function and safety.
Pioneer and Leader
Living Immune Cell Manufacturing
Mirror Biologics is a pioneer and leader in the GMP manufacturing of living cell products. The use of living cells as therapy has become one of the fastest-growing segments in the life sciences industry. Production and distribution of living cell products has unique challenges as compared to manufacturing of pharmaceuticals or monoclonal antibodies. Living therapeutic cells are regulated as biological drugs. Unlike pharmaceutical products, a biological drug is licensed together with the facilities and processes for production of the drugs. Recognizing this, Mirror Biologics invested early in developing and optimizing the manufacturing processes and associated quality control testing requirements for our living cell products. Because we pre-defined the identity and function of our drug in the specifications under our Investigational New Drug (IND) applications, we are able to incorporate equipment, reagent and process changes designed to optimize, scale-up or incorporate automation into our manufacturing processes without the risk of having to re-do clinical trials for each change. Our technology transfer team incorporates each change and we subsequently conduct trial production runs with the updated process to demonstrate that the pre-determined identity and function of our living cell products have not changed.
Artificial Lymph Node
Bioreactors
A central part of our strategy to leverage the economic advantages of our “off-the-shelf” technology is to expand the number of treatments that can be derived from an individual donor. We have developed a proprietary bioreactor system that solves many of the problems associated with large-scale cell expansion. The major limiting factor of bioreactor scale-up is the availability of dissolved oxygen in the culture media. Unlike blood that has red blood cells with hemoglobin molecules to sustain high levels of oxygen availability, bioreactors are limited by the amount of oxygen that can dissolve in a liquid. Generally this limits the density of cells to around 1 x 10 cells/ml. Our artificial lymph node bioreactors have a patent-pending design that provides sufficient oxygen to support cell densities approaching 1 x 10 /ml. This means we can produce approximately 100-fold more cells per unit volume than current technology, providing a significant cost savings.
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Automated Manufacturing
Cloud Controlled Pods
In order to assure rapid expansion of manufacturing capacity, we have developed a unique business model. We develop our manufacturing systems in “pods”. These pods contained an automated, closed, sterile production system with “plug-and-play” disposable components and reagents. A pod can produce sufficient doses to treat approximately 100 patients a month. Only a single pod is required in order to submit a Biological License Application (BLA) to regulatory authorities. Once approved, the pods can be “cloned” and placed anywhere in the world they are required in accordance with demand and logistics.
The pods are “fed” with source blood derived from “blood pods”. The blood pods are donor centers that can be located in areas that can support large numbers of healthy paid donors (such as near college campuses). The source blood collected from the blood pods is processed into a frozen product from further manufacturing use and shipped to a cell processing pod as required. A logistics manager can route the blood so as to maintain maximal capacity at all the pods. The plug and play disposables, reagents and media are manufactured in-house and distributed to the pods on a just in time basis. The cell processing pods produce a final frozen dosage form which is distributed to clinics or regional distribution centers around the world.
Each pod can be considered to be a “franchise”, some owned by Mirror (franchisor) and some to a franchisee or as a joint venture in order to accommodate various regulatory and logistical issues on a country-by-country basis. Each pod becomes it’s own profit center. The entire network of blood pods and cell processing pods will be connected by internet cloud to Mirror central monitoring and control facility. In this manner, senior regulatory management is not required at each pod, the release of product will be done centrally. This is not only cost effective, but will assure world-wide, pod-to-pod consistency in product quality, function and safety.
The same cloud internet connection is established with our clinic providers. In this manner, our Medical Affairs department can provide real time medical support and advise to physician users in rural clinics and third world environments, as well as in major medical centers providing expanded acceptance and access.
