Showing posts with label regulatory affairs. Show all posts
Showing posts with label regulatory affairs. Show all posts

Sunday, 22 February 2015

What is Dendritic cell based Immunotherapy and T cell Adoptive Transfer therapy.

In this blog we are going to serve the details of dendritic cell based Antibody Drug Conjugate and Adoptive T cell transfer therapy.

Regarding dendritic cell based therapy; one must know that dendritic cells have the ability to be stimulated to produce a cytotoxic response towards a certain antigen.

Mainly for this to happen, dendritic cells which are a type of cells that present antigens, are collected from a patient. Then these cells are either transfected with a unit of a virus or are pulsed with an antigen. When the sample is reintroduced into the patient, as a result of the activation of these cells, they present the tumor antigen into the lymphocyte effector, which is made of CD4, CD8, T Cells, and B cells.
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This leads to an initiation of a cytotoxic response to the cells that are expressing the tumor antigen. An example of this approach is Sipuleucel T which is used mainly to treat patients with metastatic prostate cancer (HRPC).

On the other hand, the Adoptive T cell transfer, is mainly the transfer of T cells to produce a cytotoxic effect to attack cancerous cells, naturally these types of cells are reactive to cancerous cells. To introduce them to patients, they are generated in vitro and then re-introduced to the patient.

An example of this was shown in a study where there is introduction of lymphocytes that were autologous and tumor penetrating as an effective treatment for metastatic melanoma. In accordance to this procedure, the following must occur:

First the T cells that are inside the tumor within the patient must be extracted. Then these T cells are trained to battle the tumor cells, usually these are referred to Tumor infiltrating lymphocytes (TIL).

Then they are grown in vitro using high concentration. Of allo-reactive feeder cells, IL2, & anti CD3. Then these T cells are transferred back and introduced into the patient with the administration of IL2 exogenously to further increase noticeably their anti-effect on cancer. This leads to about a 51 % objective response rate, and in some cases the tumors were undetectable in size.

Thus, in this way it has been introduced the details of dendritic cell based therapy and adoptive T cell transfer and it’s used for treatment.

Global Allied Pharmaceuticals is providing immunotherapy and immune-oncology services since more than 14 years. Contact us at www.gapsos.com.

Wednesday, 28 January 2015

Cure of cervical cancer patients is possible with immunotherapy.



Cancer that begins in the cervix (part of human female reproductive system) is known as cervical cancer. The normal cells of cervix changes into abnormal cells due to DNA mutation (mutation caused by Human Papilloma Virus, also named as HPV), and cause this cancer. This cancer is one of the leading causes of the death related to cancer across the world. According to analysis it is found that about 12,500 newly cases are diagnosed and about 4,000 cases of death related to this cancer, in 2014. More patients are cured with the help of immunotherapy

Cervical cancer begins in cells on the surface of the cervix can be benign or malignant. Benign are not a form of cancer and not as harmful as malignant (cancer). Benign forms of this cancer are rarely a threat to life, and do not invade the tissues around them. Malignant forms of this cancer may be a threat to life can invade the tissues and organs around them, and can spread (metastasis) to other parts of the body. Over time, the cervical cancer can invade more deeply into the cervix and nearby tissues.



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The classification of stages of this cancer is based on where cancer cells are found that involve stage I, stage II, stage III, and stage IV. These are the stages of invasive cervical cancer. Stage I of this tumor has invaded only in the cervix nearby the top layer of cells. Stage II of this tumor does not invade to the pelvic wall and extends nearby tissues toward the pelvic wall. Stage III of this tumor has invaded the pelvic wall extends to the lower part of the vagina. Stage IV of this tumor invades the bladder or rectum or the cancer has spread to other parts of the body.

Any symptoms are seen in an early stage of this tumour is found in very rare case. Almost symptoms are seen in advanced stages that involve abnormal vaginal discharge including bleeding (bleeding after sex, bleeding after menopause, and irregular menstrual cycle), pelvic pain during sex, and infections. 
 
Cervarix and Gardasil, both are therapeutic vaccines as well as immunotherapeutic cancer agents, have received Food and Drug Administration (FDA) approval for the treatment of this cancer. Both vaccines are indicated for the prevention of this cancer, which is caused by HPV. Much more immunotherapeutic cancer agents are under process of FDA approval for this cancer.

Global Allied Pharmaceuticals (GAP) has technology to treat various cancers with immunotherapy and immune combination therapy, and gives 100 percent positive results. GAP has a team of experts for development of advanced treatments on the basis of immunotherapeutic cancer agents.

Further more information about us, kindly visit at www.gapsos.com

Monday, 20 October 2014

Post market drug safety can be ensured using different methods



Most Methods are utilized to look after drugs after they are finalized or approved by FDA. This is a piece of post marketdrug safety. One of these techniques is Spontaneous reporting system. "A spontaneous report is a spontaneous correspondence via healthcare experts or customers to an organization, regulatory power or other association that portrays one or a more adverse drug reaction in a patient who was provided for one or more therapeutic items and that does not infer from a study or any sorted out information collection plan". In the event that a specialist suspects that a specific drug is connected with an adverse event saw amid the course of administering to a patient, then he or she reports that unfavorable medication response to a formal reporting system. At the point when a few specialists report drug reaction responses to a central location, the information can then be looked into and dissected for patterns. 

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One professional watching one unfriendly medication response connected with a specific medication may not consider the adverse event response to be critical or regular, yet a few experts reporting the same unfavorable event to a central regulatory affairs council takes into consideration the determination of its degree and earnestness. In this manner spontaneous reports database is generally utilized for recognizing signal (A signal is characterized as a conceivable relationship between an unfavorable occasion and a medication, the relationship being obscure or not completely reported formerly) of ADRs identified with the medication drug collaborations. 

Generally more than a solitary report is obliged to produce a sign, contingent on the reality of the occasion and the nature of the data. The distribution of a sign normally infers the requirement for an audit or activity as the reported data on a conceivable causal relationship. 

The results drawn from the spontaneous reporting are considered by the prescribers and the controllers for the remedies. Spontaneous reporting systems can be found at neighborhood, local and national levels. It is the obligation of all professionals to report suspected adverse drug responses: however the obligation regarding the creation and upkeep of the reporting systems in healthcare institutions normally falls under the pharmacy office.

For further information regarding the matter you can contact GAPSOS, a growing pharmaceutical company and a group of medical experts. Visit www.gapsos.com