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Brochure

500+ Clinical and Commercial Programs Delivered

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At Aragen , we offer comprehensive chemical development solutions that ensure successful transition of your drug candidates from development to commercialization. Our dedicated team of experts and state-of-the-art facilities provide unparalleled support across every phase of chemical development, guaranteeing high-quality outcomes with efficiency and precision.

Our Chemical Development Capabilities

Process Development and Optimization
  • Route scouting and selection
  • Process optimization and scale-up
  • PAT-enabled scientific and data driven crystallization studies (BlazeMetrics)
  • Process engineering studies (scale up parameterization studies)
  • Development of sustainable and cost-effective processes
Process Safety and Engineering Studies
  • Hazard identification and risk assessment
  • Process safety evaluation and optimization
  • Development of safe operating procedures
Analytical Development and Stability Studies
  • Method development and validation
  • In-process control and monitoring
  • Comprehensive impurity profiling
Manufacturing and IND/NDA Filing Support
  • Clinical and commercial manufacturing
  • 50 L to 12,500 L scale reactors
  • Comprehensive documentation and
    filing support for IND/NDA and DMF submissions

Regulatory Approvals

Integrated end-to-end DS/DP Solutions

  • Tox to Clinic (FIH): Efficient transition from toxicology to First-in-Human trials
  • DS/DP Scale-Up: Scalable DS/DP production from lab to commercial scale
  • Method Development: Tailored methods for efficient manufacturing and quality control
  • Form Selection: Optimized polymorph, salt, and solid-state form selection
  • Formulation Development: Customized formulations for enhanced bioavailability and stability
  • Regulatory Solutions: Regulatory-ready processes for seamless IND/NDA submissions

Chemistry and Technologies

Cross-Coupling Chemistry :
  • Organometallic reactions like Heck, Suzuki,
    Negishi, Buchwald-Hartwig
Halogenation Chemistry:
  • Fluorination/Bromination
Hazardous chemistry involving:
  • Cyclopropanation
  • Azides
  • Cyanations
  • Nitrations
  • Lithium/Borane
  • DIBAL/Sodium
  • Borohydride
  • Hydrogenations
  • Exception – Use of HF(g) and Phosgene(g)
Specialized areas:
  • Amino acids, Peptides
  • Carbohydrates, GalNAc
  • Lipids, PEGylated lipids
  • Amidites, Nucleosides and Nucleotides
  • Pressure reductions/Reactions (up to 25 bar)
  • Chemo/Biocatalysis
  • Particle engineering studies
  • Solid form screening and development
  • Flow and Photo-Flow reactions
  • ADCs linkers and toxins
  • ADCs linkers and toxins
  • OLEDs

Operational Capabilities

Security of three sites at Hyderabad and Vizag to ensure timely delivery and business continuity.

  • 11 process blocks across three sites
  • Total reactor capacity of 365 KL with the range of 20L to 12500L with the MoC range of SS, MS-GL and Hastelloy
  • Hydrogenator (100L & 1kL- Hastelloy, 100L to 5kL- SS)
  • Cryogenic reactors (100L to 10kL) operating up to -80°C
  • Powder processing (jet mill, multimill, fleximill & pinmill/Hosokawa)
  • cGMP and nGMP available HPAPI facilities handling up to 10ng/m3
  • Operating pressure: full vac to 25 bar
  • Operating temperature: -80°C to +200°C
  • Comprehensive set of analytical capabilities performed
  • 100% in-house (non-GMP & GMP)

Why Aragen?

  • 4,300+ scientists incl. 450+ PhDs
  • 400+ clients globally including late preclinical and commercial phases
  • Partnering with 15 out of top 20 pharma companies
  • Active +100 early, late, and commercial projects (both non-GMP and GMP)
  • Complete support for IND, NDA, DMF filing

FAQ

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