Over the past decade, peptide drug discovery has experienced a revival of interest and scientific momentum, as the pharmaceutical industry has come to appreciate the role of peptide therapeutics in addressing unmet medical needs. The number of peptide-based drugs in advanced clinical trials has grown significantly with their diverse clinical applicability. The development, testing and commercialization of a new drug takes more than a decade of work and high levels of investment.
The state-of-the-art R&D facility of ISSAR engages in peptide molecule designing and optimization, formulation development, analytical validation techniques, and Stability studies. ISSAR Pharmaceuticals is focused on discovery and development of peptide based New Chemical Entities (NCEs), which are best in class with anti-microbial, anti-inflammatory and anti-angiogenic properties for a wide range of disease areas such as inflammation, wound healing, infections, psoriasis, ulcerative colitis and pigmentation disorders. Scientists at ISSAR adopt cutting-edge science and technology to reach the targets at an efficient pace. The therapeutic targets include VEGFR, p38, MPO and inflammatory markers.
ISSAR Pharmaceuticals displays an outstanding expertise in developing new formulations with an objective to introduce first-to-market products providing dosage forms with better patient compatibility and convenience. From laboratory procedures to GMP, ISSAR takes continuous initiatives towards technology adaptation and innovation.
Pharmaceutical formulation development is based on compilation of activities which help in determining the dosage form, route, composition and manufacturing. These involve functions such as pre-formulation, including analytical assay development and characterization, excipient screening to stabilize or enhance the solubility of the product and dosage form development, whether it involves a solid, topical, aerosol, liquid or lyophilized dosage form. Formulation development may also include assessing delivery options and delivery device compatibility.
ISSAR’s formulation development strategy is based on in-depth study of patents, scientific literature, compendia information, Critical Quality Attributes (CQA) and Quality Target Product Profiles (QTPP) of the respective drug delivery system and nature of the molecule.
ISSAR has an FDA-compliant, 62,000 sq ft manufacturing facility for topical, injectable, and other peptide formulations at varying scales from gram to multi kilogram scale. The synthesis of novel therapeutic peptides is carried out by solid phase peptide synthesis process. The raw materials of the molecules are processed through synthesis and cleavage, followed by purification. The purified product is lyophilized to obtain the peptide in its final powder form. The peptide obtained is then formulated for manufacturing the specific ointment, cream or lotion.
• Process Development For Peptides
• Patent Non- Infringing Process
• Pilot and Scale up Studies
• Formulation Development
• Pre Formulation Studies
• Lyo- Cycle Development and scale-up
• Analytical Method Development and Validation
• Impurity Determination and Characterization