جستجوی مقالات مرتبط با کلیدواژه "gmp" در نشریات گروه "پزشکی"

Among different kinds of cells involved in the wound healing process, fibroblasts play a pivotal role in the proliferation phase of this procedure wherein they induce the production of local growth factors and cytokines. Fetal fibroblasts with low immunogenic property and different wound healing process could be considered as a suitable alternative to neonatal foreskin cell based products in regenerative medicine and cell therapy. Cell therapy is an almost newly introduced method in the medical field and is also a challenging issue, which should assure the safety of the final product and the absence of viral or bacterial contamination with minimal immunogenic response. Therefore, based on current GMP (cGMP) principles, it is a matter of great importance to monitor raw materials’ quality and the conformity of all production procedures including cell culture, collection, and cryopreservation with validated standard operating procedures (SOPs). In the current study, we demonstrated the GMP-compatible and clinical-grade fetal fibroblast cells banking to be used for clinical applications.
All steps of isolation and culturing and cryopreservation of fetal fibroblast cells were performed under the sterile condition according to cGMP guidelines in the clean room. During the cell culture procedures, bacteriological investigation was performed in order to identify the probable contamination of the samples.
Isolated fetal dermal fibroblasts were harvested and stored at early passages. The viability of fibroblasts was ≥ 98%, indicating successful establishment of fibroblast banking. Flow cytometry analysis has revealed the high purity of isolated and cultured fibroblastic population Karyotyping of fibroblasts at the 10th subculture shows a normal diploid male pattern.
The manufactured cells, according to the highest level of safety are considered as the most appropriate treatment option for cellular therapy. Based-on the current evidence, clinical-grade fetal fibroblasts throw new light on efficient and prompt healing of acute and chronic wounds of any etiology.

Just like any other process, vaccine manufacturing procedures are defined as a series of interrelated functions and activities using a variety of specified actions and equipment designed to produce a defined product. To assure the reproducibility and consistency of such processes, they must be carried out using validated equipment and under the established procedures that meet all the acceptance criteria, at least 3 times. In many cases, “worst case” conditions are used for the validation purposes to ensure that the process would be acceptable in extreme cases. Therefore, the validation concept in vaccine production facilities is a key element of the quality assurance goals which may reduce the dependence upon intensive in-process and finished products testing. Nevertheless, the concept of validation has expanded through the years to embrace a wide range of activities such as analytical methods used for quality control of drugs, the computerized systems for the clinical trials, the labeling and the process control. To perform such validation activities properly, the updated knowledge of the current regulations are needed. Therefore, the present article focuses on the recommendations in the related guidelines addressing different aspects of validation procedures related to the vaccine production facilities as a part of the product’s life-cycle.