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’s 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.

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 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 DAC columns, with dimensions size 150 x 650 mm and 200 x 650 mm. The individual instrument flow rates are 100 ml to 1000 ml per minutes (150 mm DAC) and 200 ml to 2000 ml per minute for 200 mm DAC instrument. Both these columns are suitable to scale in manufacturing of peptides from a gram to kg.

Post purification supporting systems like Rotavapour and also lyophilizers for concentration and lyophilization of the desired peptides to scale from gram to kg is available. The department is also equipped with LCMS and HPLC systems for analysing online samples other than the complete analysis at QC.