November 25, 2017

الإدارات

Research

Quality Assurance

Production

Quality Control

Research & Development:

In order to optimize the stem cell production process, improving quality and cost-effectiveness of products under cGMP standards, the R&D section of Cell Tech Pharmed co. stablished in March 2014. The goal of the department is new designed projects to improve and develop the cell manufacturing industry as an advanced therapy medical products (ATMPs). Regarding to have benefit from the knowledge and experience of professors, medicines and researchers of Royan Institute, R&D section make great and extend cooperation with Royan Institute.

In the same line, while the Cell Tech Pharmed co was implementing the project plant, launched the process of optimizing the production process of cell products in two general plans.

Development of cell products company pipeline: These projects are related to receiving CTDs and SOPs of technical knowledge, which is modified, completed and rewritten according to the manufactory specific and legal requirements of the food and drug administration (FDA).

 

Quality assurance (QA):

Achieving quality objectives in a production line requires a quality management system. This system needs comprehensive design and implementation methods. Pharmaceutical industry and ATMP are assessed as the safety, quality and efficacy of products based on compliance of rules and regulation through the product life cycle. The product life cycle is including the principles of optimal clinical trials and optimal methods for producing, analyzing, storing and distributing pharmaceutical products that generally expressed in terms of the GXP expression.

The pharmaceutical quality management system in the Cell Tech Pharmed co is based on the proposed models by recognized organization such as ICH in ICHQ10 and PIC/S structure. In addition, this company also has other quality management system such as ISO 9001:2015, ISO 14001:2015, OHSAS 18001:2007.

The quality assurance section and chief scientific officer are supervised on design and implementation of product’s quality, quality risk management (PQM) and product quality review (PQR) and also knowledge management through product life cycle.

The quality assurance section of Cell Tech Pharmed co consists of 4 parts:

Metrology: This section consists of the following parts: validation, quality assurance and calibration. In the Cell Tech Pharmed co validation (process validation, analytical method validation and quality assurance {quality assurance of building, equipment and support system}) are carried out with a concurrent approach. Calibration is also one of the most important tasks of this department, which is managed by using the developed internal software.

 

Documentation: This part specialist will be responsible for assisting in the implementation and maintenance of the Quality Management System (QMS) by coordinating the revision and review of documents under control of QA and other cooperate departments which play role in quality, document control function, including document login, tracking, processing, distributing and archiving and controlling electronic batch records and issuing codes for all company documents and reviewing product quality on an annual basis. It should be noted that implementation of document management and software records has been developed internally.

 

Inspection: This part’s instructions ensure that products manufactured meet GMP requirements which evaluated the periodic and systemic, effective and feasible implementation of the quality management system of the company. Inspection is required monitoring the implementation and observance of the principles of GMP and providing corrective and preventive measures (CAPA). Other tasks of this section are including that controlling personnel matters, places, equipment, documents, production, quality control, distribution of pharmaceutical products, responsibility to complaints and recall. Re-evaluation of the suppliers, services and purchased materials in order to adapt their specification of GMP requirements and internal rules of the company and their impact on products, human resources, as well as environmental performance, safety, health and other factors.

 

Production line:

Nowadays, one of the biggest health problems and complexities is the discussion of treating severe and demand illnesses that has no definitive treatment till now. In the field of rehabilitation medicine, the main aim is ability to enhance and restore functional method and quality of life to those with physical impairments or disabilities.

Accordingly, based on the results of clinical trials conducted by Royan institute for stem cell transplantation in diseases such as arthritis, wrinkled, acne scar, vitiligo and heart failure, therapeutic and beneficial effects has been proven in these patients.

In order to meet the demands of the patients, the Cell Tech Pharmed plant was established for the mass production of stem cells under GMP standards. Products which produced in the production line are including:

MesestroCell® product is applied for osteoarthritis of the knee, hip, ankle and hip

MonuCell® product is applied for ischemic cardiomyopathy and dilated/congestive cardiomyopathy (DCM) of adults

RecolorCell® product is applied for vitiligo patches

RenuDermcell® product is applied for wrinkle and acne scar

LipoVasCell® product is applied for soft tissue and skin lesions

After receiving the tissue samples such as bone marrow, skin and adipose samples from the patients, the segments will enter to production line after confirmation of their health and ultimately a cell product would have a complete identification card which is containing detailed information on cell identification and sterilization tests. After full control process, this product will deliver to the clinics for injection.

The latest cultural method of stem cell in our facility is based on sterile flask culture. By this method 3000 patients will be covered in 2017. Since the number of patients on the waiting list has increased lately, there is a need to create a way to significantly increase production capability to respond market demand.

 

Accordingly, the goal is to boost the production capability by 5000 patients per year till 2019 and for this reason, using bioreactor technique will be so helpful.

To accomplish our aim, there are trained production staffs at the plant with full knowledge of GMP regulations and product manuals. Each of this user of production line, in accordance with the appropriate coverage of the class B clean room, below the class A laminar flow, will produce product based on instructions for the processing of each product.

Our today products are autologous based (own tissue samples) stem cells but our company’s aim is to replace allogenic product by 2020. In this case, with the introduction of cell culture technology in the bioreactor and the construction of a new plant with a greater number of clean rooms, the capacity to produce allogenic products could be increased to 50000 patients per year.

 

 Quality control (QC): 

The quality control section of Cell Tech Pharmed company consists of 3 laboratories of microbiology, biochemistry, cellular& Molecular biology that along with trained and experienced experts. Various analytical and biological tests, such as sterilization, bacterial endotoxin testing, mycoplasma detection and cell counting, etc.

 

The quality control unit of Salt Tekh Fardam Company consists of 3 laboratories of microbiology, biochemistry, cell and molecules that along with trained and experienced experts. Various analytical and biological tests, such as sterilization, bacterial endotoxin testing, mycoplasma detection, and culture , Cell identity, cell counting, etc. on the raw materials, interstitial and final products, in accordance with the authoritative references in the field of cell therapy and the USP, BP drug standards.

Providing a quality control certificate for each product series in accordance with international standard protocols and valid methods is one of the main tasks of this unit. Having appropriate and calibrated laboratory equipment, and the method of accurate testing and upgrading the level of scientific knowledge of our experts, testify to the efforts and confirmation of controlling and assuring the quality of cell therapy products.