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Recombinant Hormones

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					RECOMBINANT HORMONES

WHAT ARE HORMONES?
 A hormone is a substance that is

produced by specific cells in the body and is transported through circulation to act on it’s target cells.



Hormones are secreted by the endocrine or ductless gland.

RECOMBINANT HORMONES


Recombinant hormones are hormones synthesized by using recombinant DNA technology popularly known as genetic engineering. technology is based on the manipulation of genes.

 This

What is Recombinant DNA Technology?
 Recombinant DNA (rDNA) is an

artificial

DNA

sequence

resulting

from the combining of DNA sequences that come from different sources and different species, in vitro, into virus or bacterial system plasmid and of or the the other vector

subsequent chimeric

incorporation

molecules into a host organism in which they are capable of continued propagation.

TOOLS USED IN rDNA TECHNOLOGY Restriction enzymes



 Vectors 

DNA ligase



DNA insert

RECOMBINANT DNA TECHNOLOGY

Applications of rDNA Technology


Uses of DNA Technology in Basic Research



The Human Genome Project (mapping entire human
genome)

 

Medical Uses of DNA Technology Forensic Uses of DNA Technology Uses of DNA Technology

 Agricultural

FDA APPROVED RECOMBINANT HORMONES
HORMONE
HUMAN INSULIN INSULIN ASPART INSULIN GLARGINE INSULIN LISPRO INSULIN GLULISINE SOMATOTROPIN HUMAN CHORIONIC GONADOTROPIN FOLLICLE STIMULATING HORMONE LUTEINIZING HORMONE PARATHYROID HORMONE THYROID STIMULATING HORMONE

EXPRESSION HOST
E.coli / S.cerevisiae S.cerevisiae E.coli E.coli E.coli E.coli CHO cells

THERAPEUTIC USE
Treatment of Diabetes “ “ “ “ Treatment in growth failure Treatment of women undergoing superovulation prior to ART such as IVF

CHO cells
CHO cells E.coli CHO cells

Treatment of infertility
Induction of ovulation Osteoporosis Diagnostic agent for thyroid cancer

Recombinant Insulin


Recombinant human insulin first entered clinical trials in humans in 1980. In 1982, human insulin became the first recombinant DNA drug approved by FDA

 Genentech licensed the human insulin

technology to Eli Lilly, where it was named "Humulin" or Recombinant Human Insulin.

 Used to control blood sugar in people with

diabetes

Manufacturing Of Recombinant Insulin

SIDE EFFECTS
 Hypoglycemia  Dizziness

 Blurred vision
 Sweating  Difficulty in breathing or swallowing
Insulin Lispro Injection (Humalog®)

BRAND NAMES
 Humulin R®
 Novolin R®

Recombinant Human Growth Hormone
human growth hormone (hGH) injection was first approved by FDA in 1987  It is majorly used in the treatment of growth hormone deficiency (GHD)  hGH treatment is widely used for both pediatric and adult GHD.
 Recombinant

THERAPEUTIC USES
 Prader-Willi  Wasting

Syndrome

disease, burns & trauma

SHORT STATURE CAUSED BY
 Turner’s

syndrome
short stature

 Idiopathic

 Chronic
 Pituitary

renal failure
Dwarfism

SIDE EFFECTS
  

Skin rash or itching Fluid retention Limp or pain in hip or knee

BRAND NAMES
 

Nutropin Humatrope




Genotropin
Accretropin

RECOMBINANT HUMAN PARATHYROID HORMONE


Teriparatide (Forteo) is an injectable form of human parathyroid hormone. Teriparatide is generic name for the 34-amino acid N-terminal fragment of the PTH molecule It is approved for postmenopausal women and men with osteoporosis who are at high risk for having a fracture. Unlike the other drugs used in osteoporosis, teriparatide acts by stimulating new bone formation in both the spine and the hip.







It also reduces the risk of vertebral and nonvertebral fractures in postmenopausal women.  In men, teriparatide reduces the risk of vertebral fractures. However, it is not known whether teriparatide reduces the risk of nonvertebral fractures.  Side effects include nausea, dizziness, and leg cramps. Teriparatide is approved for use up to 24 months.


RECOMBINANT HUMAN CHORIONIC GONADOTROPIN (hCG)
Ovidrel

is an FDA approved drug used to treat women who ovulate irregularly

SOME OF THE CAUSES MAY BE: Polycystic ovarian syndrome (PCOS) Insufficient production of LH & FSH by pituitary Thyroid disease Prolactin excess Obesity Eating disorders Extreme weight loss or exercise

 Also

used in the treatment of amenorrhea (absence of menstruation) or irregular menstruation prescribed for women who have tried clomiphene citrate without success whenever possible treatment should be directed at correcting the underlying cause

 Often

 But

ASSISTED REPRODUCTIVE TECHNOLOGY (ART)
In vitro fertilization (IVF) which is a form of ART have become accepted medical treatments for infertility  The basic steps in IVF treatment are:  Ovarian stimulation  Egg retrieval  Insemination  Fertilization  Embryo culture  Embryo transfer


DRUGS FOR OVARIAN STIMULATION
Recombinant Follicle Stimulating hormone (recFSH) drugs  Follistim  Gonal-f Recombinant Luteinizing hormone (recLH) drug  Luveris  Administered subcutaneously

Recombinant human chorionic gonadotropin (rechCG) drug


Ovidrel

 Administered subcutaneously.

SIDE EFFECTS
 There

are no known side effects if only rechCG is taken

RISKS OF ART


Ovarian hyperstimulation syndrome (OHSS) Increased incidence of multiple births Miscarriage or ectopic pregnancy

 



Premature delivery

THYROGEN
(thyrotropin alfa for injection) is indicated for use as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer  Thyrogen (thyrotropin alfa for injection) is also indicated for use as an adjunctive treatment for radioiodine ablation of thyroid tissue remnants in patients who have undergone a near-total or total thyroidectomy for well-differentiated thyroid cancer
 Thyrogen

SIDE EFFECTS
 Headache  Nausea, vomiting  Feeling  Fever  Chills

tired

 Dizziness

Erythropoietin


Recombinant human erythropoietin (rhuEPO) is widely used for the treatment of anaemia associated with renal failure, HIV infection, cancer and surgery.



Two varieties of rhuEPO, i.e. epoetin alfa (Epogen, Procrit), epoetin beta (Mircera) are available for clinical use  Epoetin alfa and epoetin beta are produced in CHO cells, whereas epoetin omega is produced in BHK cells  Recently, novel erythropoiesis stimulating protein, darbepoetin alfa (Aranesp) has been developed for the treatment of anaemia  SIDE EFFECTS
      

headache joint or muscle aches, pain, or soreness nausea vomiting

indigestion
stomach pain diarrohea

CONCLUSION
have a long history of use as therapeutic agents  Since it first became available insulin has saved or prolonged the lives of millions of diabetic people  Gonadotropins have allowed many infertile women to conceive  Growth hormone has improved the quality of life of thousands of people with short stature  Most such hormones were in medical use prior to the advent of genetic engineering  Recombinant hormonal preparations are now, however gaining greater favour, mainly on safety grounds  Hence hormone therapy will remain a central therapeutic tool for clinicians for many years to come
 Hormones

REFERENCES

 


 

G.M. Bhopale & R.K. Nanda , Recombinant DNA expression products for human therapeutic use. CURRENT SCIENCE,VOL. 89, NO. 4, 25 AUGUST 2005.pdf AMERICAN SOCIETY FOR REPRODUCTIVE MEDICINE: ASSISTED REPRODUCTIVE TECHNOLOGIES; A guide for patients.pdf Ora Hirsch Pescovitz, Alan Rogol, Ron Rosenfeld: Growth Hormone Issues in children & adults.pdf; THE HORMONE FOUNDATION Shelley M. Martineau, Jessica A. Matthews, Catherine C. Miller, Carol D.Riley; Recombinant DNA technology in today’s medicine.ppt Growth hormone uses & abuses – Hintz 328 (7445) 907 – BMJ

WEBSITES
www.nlm.nih.gov/medlineplusr www.sart.org www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm www.aidsinfo.nih.gov


				
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