Issar is purely Peptides manufacturing technology based company, with state of art facility located at Genome Valley, Hyderabad, India. Our expertise lies in synthesis and purification of peptides by novel methods with highest standards of purity. Our Patented Synthesis and Purification processes provide highest purities of post synthesis and post purification of peptides. We are well equipped and experienced for synthesising polypeptides up to 50 amino acids. Our purification facility is capable of handling peptide purification from gm scale to kg scale.

We are the only Pharmaceutical company in India whose facility is dedicated exclusively for manufacturing of Peptides. Also, the only company that is working on novel peptides with several new peptide drugs which are in the pipeline and at different development stages with patents. Our papers are published in several reputed International Journals.

Issar R&D has the ability to move Products and Projects from Conceptualisation to Commercialisation. Our R&D department is well equipped and well experienced in appraising the prevalent production systems, identifying loopholes if any, undertaking result-oriented measures for alleviating them and documenting the same.

The technology developed by our R&D department demonstrates our abilities in development, validation, technology transfer and troubleshooting of the manufacturing process. Issar is working in collaboration with several international projects and has experience working with high performance teams on technology development and commercialisation of peptide molecules.

Our R&D developmental work is in accordance with Regulatory parameters of working on GMP & GLP requirements, and also strictly following the ICH & USP guidelines. We are dedicated in providing highest quality of peptide based products by following absolute standards in quality.


Peptide Synthesis:

Peptides can be obtained chemically either by Solution-phase synthesis, or Solid-phase synthesis (SPPS), or even by a combination of both methods which, can involve various ligation strategies.

At ISSAR PHARMA, the synthesis of peptides is carried out on solid phase synthesis(solid support: Polystyrene, crosslinked with 1% divinylbenzene). Over the years, this method has shown a shift within the peptide synthesis community, and has now become the standard method for synthesising peptides and proteins.

General scheme of solid phase peptide synthesis: C to N direction. Synthesis cycle consists of De-protection, Washing's, Coupling and Washings to remove excessive material.

Peptide Synthesis

Custom Peptide Synthesis:

ISSAR peptide production has a substantial, long –standing expertise in custom peptide synthesis services, peptides like, Bivalrudin, Oxytocin, Atosiban and Leuprolide etc….. We are sufficiently equipped to provide custom peptides with highest quality for complex or rare peptide sequences.

ISSAR developed a well researched knowledge to optimise the appropriate peptide synthesis method for each peptide.

Peptide Capabilities:

Peptides manufactured on demand
Good peptide synthesis and purification labs
Consultation with experienced peptide chemistry experts
Peptides from 5 to 25 Amino acids
Scales from milligram to kilogram
Purities from ≥ 98%
Cyclic peptides Cys to Cys
State of the art Equipment


Purification:

Issar's purification department is well equipped with fully automated state of the art facility that is capable of purifying peptides from milligram to grams. The purification facility can be scalable from simple pilot systems to production scale levels.

The purification department is equipped for developing scale-up studies and optimising the peptides purification from mg scale to gram scale. For gram scale development and process optimisation a pilot system with collapsed columns of different sizes are available. The pilot system is equipped for linear and volumetric scale purification development and is equipped with gradient as well isocratic pumps which can be simulated with the production level purification systems and columns with required pressure and flow rate.

For manufacturing scale purification of peptides at Issar we have two Hanbon instruments equipped with a DAC columns, one column with dimensions size 150 x 650 mm and another with dimensions size 200 x 650 mm. The individual Hanbon instrument flow rates are 100ml to 1000 ml per minutes (150mm DAC) and 200ml to 2000ml per minute for 200mm DAC instrument. Both these columns are suitable to scale in manufacturing of peptides from a gram to kg.

Post purification supporting systems like Rotavapour (Buchi) and also Lyophilizers for concentration and Lyophiliztion of the desired peptides to scale from gram to kg is available. Department is also equipped with Shimadzu HPLC system for analysing online samples other than the complete analysis at QC.

Burn Wounds

Globally the first synthetic peptide based topical product in burn wound care. Completed all three phases of clinical development in India and submitted a dossier to Indian Regulatory for marketing approval. In the Phase III Clinical trial, apart from controlling infection, fastened wound healing, the product improved quality of life in burn wound patients, by reducing Post-Burn effects.

The Phase III Trial data has been presented at 17th Congress of the International Society for Burn Injuries (ISBI) Pre-Congress Work Shop on 14th October 2014, Sydney, Australia.

Product Name Xylentra™
Dosage Form Topical
Result Triple Action – Controls infection, accelerates wound healing & prevents scars.
Patent Patented
Expected Launch 2017

Burns are one of the most common household injuries, especially among children. The term “burn” means more than the burning sensation associated with this injury. Burns are characterized by severe skin damage that causes the affected skin cells to die.

There are three primary types of burns: first-, second-, and third-degree. Each degree is based on the severity of damage to the skin, with first-degree being the most minor and third-degree being the most severe. Damage includes:

  • first-degree burns: red, nonblistered skin
  • second-degree burns: blisters and some thickening of the skin
  • third-degree burns: widespread thickness with a white, leathery appearance
  • There are also fourth-degree burns: This type of burn includes all of the symptoms of a third-degree burn and also extends beyond the skin into tendons and bones.

Most people can recover from burns without serious health consequences, depending on the cause and degree of injury. More serious burns require immediate emergency medical care to prevent complications and death. Burns injuries are a global public health crisis, accounting fourth most common type of trauma worldwide, for an estimated 265,000 deaths annually. The majority of these are among the leading causes of disability adjusted life years (DALYs) lost occurs in low and middle income countries and almost half occur in the WHO South East Asia Region. Although small burns are not usually life threatening, they need the same attention as large burns, in order to achieve functional and cosmetic outcome. The majority of patients sustain burns of such limited severity and extent (>80% of burns involve <20% of the body surface) that they can be treated on an outpatient basis. Approximately 33% of subjects who require in-hospital care have a major burn injury as defined by the American Burn Association on the basis of burn size, causative agent, and associated injuries and should be treated in a tertiary care burn center. Burn wound infection is a major cause of morbidity and mortality after initial period of shock estimating about 75% of the mortality following burn injuries is related to infections. Burn wound infection is problematic because it delays healing, encourages scarring and may result in bacteremia, sepsis or multiple-organ dysfunction syndrome whereby organs from several systems are unable to maintain homeostasis on their own, requiring immediate medical attention. The spectrum of infection ranges from asymptomatic colonization to bacteraemia to death. Over the past 20 years, significant changes in the microbial ecology of the burn wound have been noted.

Inflammatory Bowel Disease

The Issar pharmaceuticals developed a synthetic peptide having anti-inflammatory properties studied initially by using IL-10 knock-out Murine colitis Model and later confirmed by DSS induced rat model which was evaluated by DAI, Histopathology and Biochemical markers. After reviewing the efficacy results the proof of concept studies and toxicological studies are planned.

Dosage Form Injectable
Clinical Trials
Patent Applied for Patent Protection

Ulcerative colitis (UC) is one of the 2 major types of inflammatory bowel disease (IBD), along with Crohn disease. Unlike Crohn disease, which can affect any part of the gastrointestinal (GI) tract, UC characteristically involves only the large bowel. Ulcerative colitis (UC) has 2 incidence peaks, one in adolescents and young adults and the other in middle-aged men and women. Men and women are about equally affected. Overall, inflammatory bowel disease is more common in white individuals than in black or Asian Americans with estimated annual incidence of ulcerative colitis ranges from 4 to 20 per 100,000 individuals. Smoking appears to confer protective effects: the incidence of inflammatory bowel disease is decreased in smokers, and when the disease does occur, it tends to be less severe.

Solid Tumours Cancer

The Issar developed a synthetic peptide in injectable form, which was evaluated in a Solid tumour Cancer Phase 1 Clinical Trial, conducted in India. The Phase I Clinical Trial data has been presented at the American Association for Cancer Research (AACR) Annual Meet 2013 held in Washington, USA.

Phase II Clinical Trial dossier has been submitted to the Indian Regulator for approval.

Dosage Form Injectable Peptide
Clinical Trials Phase I conducted in India. Phase II dossier submitted to Indian Regulatory.
Patent Applied for patent & Under review

Solid tumors are abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumors may be benign (not cancerous), or malignant (cancerous). Different types of solid tumors are named for the type of cells that form them. Examples of solid tumors are sarcomas, carcinomas, and lymphomas. Many types of solid tumors, whether a sarcoma or a carcinoma, are often treated with surgery. Solid tumors make up about 30% of all cancers in children. The most common type of solid tumor found in children is a brain tumor. In 2005, 7.6 million people died of cancer out of 58 million deaths worldwide. More than 70% of all cancer deaths occur in low and middle-income countries, where resources available for prevention, diagnosis and treatment of cancer are limited or nonexistent. Based on projections, cancer deaths will continue to rise with an estimated 11.4 million dying in 2030.

Psoriasis

Issar pharmaceuticals developed a synthetic peptide for psoriasis which has remarkable potential in efficaciously attenuating the symptoms and processes underlying psoriasis-like dermatitis in mice. Being a lytic synthetic peptide having anti-angiolytic activity and anti inflammatory properties that could antagonize the deleterious effects of the pro inflammatory mediators responsible for the onset of the chronic disease, they may therefore prove to have potential in preventing, delaying and curing the disease and can open the way to new therapeutic strategies for psoriasis treatment.

However, though IMQ-induced dermatitis in mice may share the cytokine profile and histopathological findings to those of the psoriatic lesions in humans, further research is required to validate that they are the corresponding disease expressions. The current findings on the psoriasis-like mice model could be found appropriate on the human psoriatic model only after such validations and further clinical researches.

The peptide has completed Mechanistic profiling and shown good safety profile completed acute safety studies in rodents. Safety pharmacology and long term safety studies are proposed.

The peptide has been applied for patent protection. US IND filing is planned.

The peptide has shown efficacy in multiple animal models. It inhibited various cytokines (in vitro & Invivo), that are implicated in Psoriasis pathogenesis. The peptide is non-mutagenic, non-hemolytic. Non-GLP toxicity studies showed very good safety profile. GLP Toxicology programme is proposed. Mechanistic studies have been completed. The peptide has been applied for patent protection. US IND filing is planned.

Dosage Form
Clinical Trials
Patent Applied for Patent Protection

Psoriasis is a chronic inflammatory disease, which affects skin and small joints. It has an autoimmune mechanism, the autoantigen was not even determined. It can affect 2–4% of the worldwide population. Most of the patients present psoriatic lesions on scalp, elbows and knees. While it affects people of all ages, disease onset is commonly between the ages of 15-25. Up to 30% of people with psoriasis will also develop psoriatic arthritis.

Diabetic Ulcer

Diabetic foot ulcer

ISSAR Synthethic Peptide represents a giant step forward in the treatment of chronic Diabetic foot ulcer,many concerns about the management of diabetic foot ulcers with Synthethic Peptide remain to be answered. In the future, it appears hopeful that a new generation of therapy will follow Synthethic Peptide for the treatment these chronic wounds.

What is Diabetic foot ulcer?

Diabetic foot ulcer is a major complication of diabetes mellitus, and probably the major component of the diabetic foot. It occurs in 15% of people with diabetes and precedes 84% of all diabetes-related lower-leg amputations. Diabetic neuropathic foot ulcers represent a serious health care burden to patients and to society. While the management of chronic diabetic foot ulcers has improved in recent years, it remains a frustrating problem for a variety of clinicians. Diabetes mellitus leads to a host of serious complications in multiple organ systems. Eventually, 15%–25% of all people with diabetes will develop a foot ulcer at some point in their lifetime. The management of foot ulcers and their associated morbidities is a leading cause of hospitalizations, and the occurrence of a foot ulcer significantly increases the risk of an amputation in diabetic patients. In fact, approximately 85% of all amputations for diabetic limbs were preceded by ulcers, culminating in 60,000–80,000 amputations performed yearly secondary to the failure of such wounds to heal. Indeed, most lower extremity amputations are performed in diabetic patients. The risk of death for a diabetic person who ends up with a below-knee amputation is 50% over 5 years. Much of this increased risk is attributable to the increased work of ambulating with a prosthetic limb and the resulting myocardial strain in these patients, most of whom have cardiovascular disease (Centers for Disease Control and Prevention 2005; Cowie et al 2006).

Dosage Form Topical
Clinical Trials
Patent