BioViz Technologies Pvt. Ltd.
BioViz Technologies Pvt Ltd is started with a vision to provide unique and versatile range of recombinant biophamaceutical products for human health care and to improve the standards of human life. BioViz Technologies Pvt. Ltd. has strategically planned to develop recombinant products of different Spectrums.
Brief history of the company:
Incepted in May 2007, we have initiated our basic R&D in December 2007 at IDA - 7, Opp: Jedimetla post office, Jeedimetla, IDA, Hyderabad. Bioviz Technologies Pvt Ltd is involved in intensive research for the development of chemicals and recombinant DNA derived products of therapeutic and industrial importance. Today we are a partner of choice, when it comes to research based recombinant products, with a chosen emphasis on Therapeutic Proteins. Various recombinant products of our company are in different stages of development under a single roof with State-of-art facility for molecular biology, protein purification and fermentation technology.
To establish as a global brand for driving standards in the space of Therapeutics products by inculcating strong ethics, quality practices and creating stakeholders values.
We are committed to improving the quality of lives of patients. We are creating innovative therapeutics by providing disease-modifying drugs to address inflammatory disorders that are not adequately treated with existing therapies.
The main objectives of the company are
- Technology development,
- Technology transfer and
- Out sourcing the facility and products
- Contract Research
The company is aim to develop therapeutic bio similar molecules which are having high market potential with good therapeutic applications. Some of the products under plan and development include FSH (Follicle stimulating hormone), EPO (Erythropoietin), GCF (Granulocyte Colony Stimulating factor), GMCF (Granulocyte Macrophage Colony Stimulating factor), IFN (Interferon alpha) etc. Most of these molecules are being subjected to pegylation which helps in stability and prolonged efficacy.
- To be a front end Therapeutic protein player offering generic versions for the less regulated markets and offer a manufacturing and product research base for the EU and US markets.
- Make a conscious attempt by professionals from Biotech and Pharmaceutical industry to focus on developing a compelling model to meet the requirements of the Emerging Markets and Developed markets.
- University of Jewharlalu Nehru Technological University, Kukatpally, Hyderabad. Dr. Lakshmi Narasu & Dr. Pramila Devi Y.
- Centre for Liver Research and Diagnostics (CLRD), Kanchan bagh, Santhosh Nagar, Hyderabad. Dr. Aleem Ahmed Khan.
- Virchow Biotech, Gagilapur. Dr. T.Murali.
Present R & D:
- Pegylated GCSF (granulocyte colony stimulating Factor )
- Pegylated Erythropoietin
- Recombinant Follicle Stimulating Hormone (rFSH)
For the above mentioned biomolecules, the Present market potential in India alone was estimated to be more than Rs*l000 cores per annum. If you look at the Indian biopharmaceutical scenario, there are hardly more than two companies dealing with each of these products. For some products like FSH, hardly we can find one company. But market is going at rapid rate with increasing demands for these biomolecules in India. Even if we capture a minimum 20% of the market share of these products we will get around 20cores turnover per annum. With established facilities for R & D and production, we can launch the products within 2 - 3 years of time.
We have already developed start up technology at R & D level for clone development and expression screening. We have basic laboratory set up for this. Moreover we have strong association with reputed labs to collaborate with us at different stages of product development.
Apart from this, we have access to obtain many conventional and non conventional products related to wound healing and surgery fields; there is minimum competition for these products particularly in India.
The company has good team of out standing researchers with proved abilities in the doma1ns like Molecular biology, Fermentation, Bioprocessing, Quality control and validation. They are mainly involved in Contract research, development of cost effective technology in bioprocess1ng, and to monitor the works at facilities where the product are outsourced.
We can start marketing of these products in India and abroad right now. We are planning not set up manufacturing facility until our business reaches to 20 -25 cores turnover per annum. Till that time, we will out source the manufacturing facility as per our convenience.
Contract research is also our priority area. In this connection we have already discussed with some companies for MOUs.
We would like to outsource the rDNA products, which are having high commercial value from various companies and will be supplied to marketing companies.
The different Stages of the Present project are as following
- Establishment of Research and Development (R&D) lab with necessary facilities to for screening and expression of clones outsourced from providers. R & D activities can be carried out by cost effective methods with minimum required equipment.
- Obtaining DSIR approvals for the projects. DSIR approval entitle the company with Customs related exemptions especially when the company wish to import equipment and unique chemicals for bioprocessing
- Product registration and regulatory clearances from DBT/DST/DCGI
- Characterization of the products by checking at QC and QA levels before the product is subjected to toxicological evaluations and clinical trails
- Toxicological evaluation of the products is endorsed to the institutes that recognized and approved by DBT
- Clinical trails will be conducted by DBT recognized reputed labs and hospitals
- Pilot scale production is carried out at separate production facility set up according to GMP norms. The production facility includes fermentation and bioprocessing of the product with high end equipment
The estimated amount for the whole project is 4 - 5 crores. The initial investment on R &D set up, to get DSIR approvals, product registration is around 2 crores. Remaining amount is to be invested for production facility and validation of the product at different stages.
- Establishment of our own Research and Development (R&D) lab with necessary facilities for Cloning and expression and purification.
- Obtaining DSIR approvals for the projects.
- Characterization of the products by analysing at QC and QA level before the product is subjected to toxicological evaluations and clinical trials.
- Toxicological evaluation of the products is endorsed to the institutes that are recognized and approved by DBT.
- Clinical trials will be conducted by DBT recognized labs and hospitals.
- Product registration and regulatory clearances (DBT/DST/DCGI).
- Pilot scale production is carried out at separate production facility set up according to GMP norms. The production facility includes fermentation and bio processing of the product with high end equipment.
STATUS OF PRODUCTS AT BIOVIZ TECHNOLOGIES LIMITED
1. Peg - GCSF: Human granulocyte colony-stimulating factor (G-CSF) is produced by recombinant DNA technology. In comparison with natural products, its bioactivity is similar in vivo & in vitro. RHuG-CSF is one of the main cytokines modulating the granulocytic hematopoiesis in bone marrow. It acts on the hematologic progenitor cells of granulocyte selectively, promoting its proliferation and differentiation. It enhances the function and counts of granulocyte in peripheral blood as well.
In vitro, G-CSF stimulates growth, differentiation and functions of cells from the neutrophil lineage. It also has blast cell growth factor activity and can synergize with IL-3 to shorten the Go period of early hematopoietic progenitors. Consistent with its in vitro functions, G-CSF has been found to play important roles in defense against infection, in inflammation and repair, and in the maintenance of steady state hematopoiesis.
Also Known As: Recombinant G CSF; Granulocyte Colony Stimulating Factor, Recombinant; G CSF, Recombinant; G-CSF, Recombinant; Recombinant G-CSF.
Key Diseases for which Recombinant Granulocyte Colony Stimulating Factor is Relevant:
- Non-Hodgkin Lymphoma (Lymphosarcoma)
- Neoplasms (Cancer) , Ovarian Neoplasms
- Acute Myeloid Leukemia (Acute Myelogenous Leukemia)
- sickle cell trait Breast cancer
- HematologicMalignancies and bone marrow failure syndromes.
Therapies Related to Recombinant Granulocyte Colony Stimulating Factor
- Drug Therapy (Chemotherapy)
- Combination Drug Therapy (Combination Chemotherapy)
HIV treatment in combination with antiviral agents
- Bone Marrow Transplantation (Transplantation, Bone Marrow)
2. Peg - EPO: Erythropoietin is a glycoprotein hormone that controls erythropoiesis, or red blood cell production. It is a cytokine for erythrocyte (red blood cell) precursors in the bone marrow. Also called hematopoietin or hemopoietin, it is produced by the kidney, and is the hormone that regulates red blood cell production.
EPO is derived from genetically modified Chinese hamster ovary (CHO) cells.
Used for the treatment of Anemia due to chronic kidney disease, Anemia due to treatment for cancer, Anemia in critically ill patients, Blood doping and Neurodegenerative diseases.
Treatment with Erythropoietin results in improvement in hemoglobin levels thereby improving the quality of life in patients with chronic renal failure, cancer patients on chemotherapy, surgery patients and patients with HIV related anemia.
3. FSH: Follicle-stimulating hormone (FSH) is a glycoprotein gonadotropin secreted by the anterior pituitary in response to gonadotropin-releasing hormone (GnRH), which is released by the hypothalamus. The same pituitary cell also secretes luteinizing hormone (LH), another gonadotropin. FSH and LH are composed of alpha and beta subunits. The specific beta subunit confers the unique biologic activity. FSH and LH bind to receptors in the testis and ovary and regulate gonadal function by promoting sex steroid production and gametogenesis. FSH regulates the development, growth, pubertal maturation, and reproductive processes of the human body. FSH stimulates testicular growth and enhances the production of an androgen-binding protein by the Sertoli cells, which are a component of the testicular tubule necessary for sustaining the maturing sperm cell. This androgen-binding protein causes high local concentrations of testosterone near the sperm, an essential factor in the development of normal spermatogenesis. Sertoli cells, under the influence of androgens, also secrete inhibin, a polypeptide, which may help to locally regulate spermatogenesis.
Indications: 1. "Induction of ovulation and pregnancy in an ovulatory infertile patients in whom the cause of infertility is functional and not due to ovarian failure"
2. Development of multiple follicles in ovulatory patients participating in an Assisted Reproductive Technology program"
4. Hepatitis - B vaccine: Hepatitis B Vaccine (Recombinant) is a non-infectious subunit viral vaccine derived from hepatitis B surface antigen (HBsAg) produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain.
The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods. The purified protein is treated in phosphate buffer with formaldehyde and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate.
The vaccine against hepatitis B, prepared from recombinant yeast cultures, is free of association with human blood or blood products. Each lot of hepatitis B vaccine is tested for sterility.