Chemistry

Chemistry Services:

Izen Bio is a fast growing Contract Research Organization providing innovative chemistry solutions to global pharmaceutical , biotech and agro chemical companies. We provide custom synthesis of diverse chemical structure class including reference standards, analogues and specially designed lead molecules / building blocks.

Izen Bio is a partner of choice in the quest for "hit-to-lead" molecules in drug discovery research. We can also perform asymmetric synthesis/catalysis. We are also experienced in complex chemistry spanning over diverse chemical structure class such as Nucleosides / Nucleotides, Carbohydrates, Steriods, Peptides, Macrolides and cold labelled compounds.

At Izen Bio, we also offer process research and development services, scalability studies, and safety evaluations. We can do Scale up upto 5kg in-house and GMP batches are done with our partner. We provide analytical services such as Method development and validation, Stability studies, Impurity synthesis and profiling.

Izen Bio's 40,000 sft research campus with world class labs are equipped with NMR - 400MHz, LCMS, HPLC(3), prep HPLC, GC, FTIR, Microwave synthesizer , CEM-'Explorer' with 24 tube, Parallel Synthesizers, Hydrogenationators and Kilo lab. The team at Izen Bio has broad experience in various aspects of synthetic and medicinal chemistry with a proven track record to deliver complex custom synthesis projects within stringent timelines. Our PhD/ MS ratio is 1:4 and we always maintain 20 % buffer chemists to meet your requirements without any delay.

Izen Bio offers flexible business models such as Full time Equivalent (FTE), Fee For Service (FFS), Standalone Services, Milestone based FTE models. Our FTE rates are competitive to enable affordable innovation.


Our chemistry service offering in more detail.

  • Synthesis ofBuilding Blocks / Scaffolds / Advanced Intermediates 50-100g, ≥95% purity
  • Synthesis of Reference Standards and Impurities (5mg -100mg, ≥ 98% purity)
  • Hit to Lead optimization
    • Synthesis of Analogues (250-500mg, >95% purity)
    • Design (if required) and synthesis of Focused Library (20-70 compounds; ~50mg with >95% average purity) around known compound or internally identified hit.
  • Medicinal Chemistry Support Develop novel and economically viable routes towards Lead optimization / Structure Activity Relationship (SAR) studies including the synthesis of novel compounds.

Library Experience:

Size

  • Medium size (~70-200 compounds, 50-100mg, >95% purity, 1H-NMR & LCMS for every compound)
  • Large size (~300-700 compounds, 10-50mg, ~75-85% purity, LCMS for every compound and 1HNMR data for 10% compounds)


Reaction type

Medium size Library:
  • Cross coupling reactions (Suzuki-Miyuara, Buchwald and Sonogashira)
  • Displacement of Halogens on Pyrimidine, Pyridine, Quinazoline type scaffolds
  • Formation of Pyrazoles, Oxazoles, Pyrazolidines from 1, 3-dicarbonyl compounds
  • Formation of Urea, Thiourea, Carbamates, Carbonates and Sulfonamides

Large Scale Library:
  • Formation of Amides via acid & amine coupling using Solid Phase supported reagents for both Medium and Large Scale Library
  • Nucleophilic opening of Epoxide with Amines


Asymmetric Synthesis

We carry out asymmetric synthesis though a prudent choice of either chemical or enzymatic transformations. The optical purity of compounds is adjudged via optical rotation as well as with chiral HPLC / GC methods. In many cases, even synthesis racemic series is pursed to ensure optical integrity.
  • Synthesis in mg to multi g scale by employing chiral pool approach
  • Asymmetric synthesis of novel molecules using chiral auxiliary approach
  • Asymmetric catalysis for affecting chiral transformations for e.g. asymmetric Epoxidation (Sharpless& Jacobsen), Dihydroxylation (AD)/Aminohydroxylation (AA) and reduction reactions ( e.g. CBS catalyst)
  • Synthesis of optically active compounds via Lipase mediated enzymatic resolution apart from effecting conventional resolution using acid/base approach


Process Research Services

  • Route selection
  • Design and development of process
  • Process improvement and optimization
  • Process scalability studies and safety evaluations
  • Analytical method development and Stability studies


Analytical Services

Physico-chemcial property determination
  • Solubility of compounds, Determination of LogP and LogD, and Stability Studies by HPLC
  • Liver Microsome Assay
  • Forced Degradation Studies for drug substances

Method Development and Validation
  • System Suitability, Specificity, Precision (System & Method)
  • Linearity, Accuracy, Limit Of Quantification Detection
  • Linearity, Accuracy, Limit Of Quantification Detection

Stability Studies

Wet Analysis
  • Physical Appearance, Sample Solubility
  • UV absorbance (To determine Max and Minimum Wavelength)
  • Moisture Content determination, Loss on Drying (LOD)


Specialty Chemistry

Apart from routine custom synthesis projects (Aromatic / Hetero-aromatic / Heterocyclic Chemistry), our experienced chemists have proven their synthetic prowess in dealing with complex chemistry spanning over diverse chemical structure class:
  • Nucleoside / Nucleotide chemistry
  • Carbohydrate chemistry (Monosaccharides and Oligosaccharides - tri and tetra)
  • Modifications on Steroidal skeleton
  • Lipids – do novo synthesis or functional group manipulations
  • Peptide synthesis (solution phase and solid phase) - only for novel compounds
  • Multistep stereo-selective & specific synthesis of compounds having several asymmetric centres – Macroketone / Macrolides and Alkaloids
  • Synthesis of isotopicallylabeled (cold) compounds (D, 13C and 15N)
  • Synthesis of novel impurities found in API, Impurity profiling using forced degradation
  • Structural elucidation of unknown impurities

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