Concept to commercialization





•  Flow Chemistry  •  Green Chemistry
•  Chiral separation   •  Biocatalysis

 •    USFDA     •   QP     •   PMDA

 •    NCE/API    •    Lipids
 •    Peptides    •    HP APIs









New Age Chemistry

Flow Chemistry

+ -
  • Safer, greener and more efficient processes
  • Flexibility with reactors – static and dynamic
  • Ability to handle complex chemistry
  • Scale-up on ton scale
  • Continuous manufacturing – reaction, work up, isolation
  • Temperature: -20⁰C to +150⁰C
  • Pressure: 100 bar
  • Reactions handled: nitration, bromination, lithiation, alkylation, cyclopropanation

Biocatalysis

+ -
  • Enzyme-linked and whole-cell catalysis
  • Quick screening with Anthem’s repository of enzymes and microbes
  • Scale up for chemistry and biologics operations
  • In-house strain development – quick editing and effect analysis

Green chemistry

+ -
  • Micellar chemistry

    • Use of proprietary and commercially available surfectants
    • Routine reactions with water as solvent
    • Easy isolation of product by avoiding conventional work-up conditions
    • Green and economically viable – biodegradable and recyclable surfectants
  • Pincer catalysis

    • Screening with Anthem’s proprietary and commercially available Pincer complexes
    • Atom economical reductions of carbonyl compounds using molecular hydrogen as the reductant
    • Apt solution for hydrogenation, dehydrogenation, aromatization of dihydro- heterocycles
    • Better alternative to hazardous pyrophoric metal hydrides
    • Ease of isolation avoiding excessive solid waste generation

Medicinal Chemistry

  • Design of novel chemical entities (NCEs) based on concepts of drug design and in collaboration with In silico Molecular Modelling Group
  • Design and synthesis of novel chemical entities to identify hit, lead and optimized lead, with prior IPR evaluation
  • Design of pharmaceutically acceptable salts, pro-drugs to improve solubility, bioavailability and efficacy
  • Proprietary Natural Products inspired library (over 100,000 compounds) for target classes - protein kinases, proteases, GPCR, ion-channel, NHRs, phosphodiesterases, Ubiquitin/Proteasome etc.
  • Biological profiling of the synthesized compounds based on in vivo in vitro, and pharmacokinetics data

Manufacturing

  • GMP and non-GMP manufacturing
  • Process Validation
  • Manufacturing of molecules from early phase to commercial supplies
  • Scales: mg to ton
  • Types of reactors: SS, AGA, GLR, Hastelloy
  • Reactor capacities: 5L to 10,000L
  • Operating temperatures: -100⁰C to +250⁰C
  • Reactions: Grignard, metal mediated, cryogenic, hydrogenations etc.
  • Small scale GMP lab: 50 – 100g
  • Large scale separations – column & DAC based
  • Hydrogenators (SS and GLR), maximum capacity - 3 kL
  • Large scale flow reactors operating from -20⁰C to +150⁰C upto 100 bar pressure

Process Chemistry

  • QbD based design and development of API’s - ICH Q9/Q11 – FMEA/Risk assessment
  • Enhanced approach for development using statistical tools
  • Synthetic route design – Novel, non-infringing, faster, safer and more economical
  • Optimizing the process to have scalable and robust control strategy
  • Process optimization focusing on optimum reaction conditions and reagent quantities, minimum cycle time, maximum concentrations and telescoping of steps
  • CMC and DMF support
  • Synthesis of high potent APIs (HP APIs) – upto OEB 5
  • Toxin, linker – toxin conjugates and ADCs
  • Peptide synthesis – upto 40 amino acids
  • PEG, Gal-NAc, steroid conjugated and phospholipids

Analytical Services

  • Method development and validation
  • Reference standard qualification
  • Isolation and characterization of impurities
  • Forced degradation studies
  • Stability studies
  • Physicochemical properties
  • Polymorphism studies
  • Chiral Separation – DAC and large scale columns

Facilities

Analytical

  • •  HPLC – UV, PDA, ELSD, CAD & RI     detectors
  • •  GCMS, HSGC, LCMS, UPLC-MS
  • •  DSC & TGA
  • •  IC, pXRD, Particle Size Analyzer
  • •  NMR, FT - IR
  • •  ICP MS/OES
  • •  KF autotitrator, coulometer
  • •  DAC purification system

R & D

  • •  220 Fume Hoods
  • •  Parallel reactors
  • •  1– 5 L jacketed Glass Lined Reactors
  • •  Lyophilizer & VTDs
  • •  Pilot scale Biotage Purification Systems
  • •  CombiFlash Purification Systems

Kilo/Pilot

  • •  Overall capacity: 30kL
  • •  Maximum batch size: 75kg
  • •  Reactor capacity: 5L – 3000L
  • •  Temperature: -100⁰C to +150⁰C
  • •  Clean rooms - 3
  • •  VTDs, RCVDs
  • •  Milling – Jet, multi & wet mill
  • •  Small Scale Column Chromatography:     250kg

Commercial

  • •  Overall capacity: 150 kL
  • •  Maximum batch size: 300kg
  • •  Reactor capacity: 300L – 10,000L
  • •  Temperature: -100⁰C to +250⁰C
  • •  Clean rooms – 5
  • •  VTDs, RCVDs, RPDs
  • •  Milling – Jet, multi & cone mill
  • •  Large Scale Column Chromatography upto     1500kg

Lead the Change.

Anthem is committed to the highest standards of quality, compliance, and on-time delivery. Anthem’s culture has gained the trust of partners around the world.

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