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Your Leading Full-Service CRDMO-Powered by Digital & AI

End-to-End Drug Discovery and Development: Innovating Small and Large Molecules from Concept to Commercial

Aragen is a value-driven CRDMO with over 24+ years of experience, enabling pharma and biotech innovators to bring Molecules to Market faster and more cost-effectively. We combine Digital & AI with robust scientific expertise for small and large molecules, delivering quality, speed, and savings at every step—from discovery to manufacturing.

PARTNER WITH ARAGEN

People-Centric Culture & Leadership

  • Great Place to Work for 6 consecutive years, recognized for talent management excellence.
  • Significant investment in talent growth; comprehensive training (100K+ learning hours) and industry-leading D&I initiatives.

IP Protection—Truly Independent

  • No generic pharma or biotech parent company ensures no conflicts of interest.
  • Advanced data security (ISO 27001:2022) safeguards your IP and maintains data integrity.

Commitment to Sustainability

  • EcoVadis Platinum Medal (top 1% globally) and SBTi-approved carbon-reduction roadmap.
  • Aiming for zero landfill by 2025, on track for water neutrality by 2035, and a 50.4% reduction in Scope 1, 2, & 3 emissions by 2032.

Resilient Supply Chain & Operational Excellence

  • 95% on-time deliveries, AI-enabled sourcing, and real-time shipment tracking.
  • Continuous Excellence (ACE) program drives lean principles, Kaizen, and Six Sigma—backed by multiple industry awards.

Powered by Digital & AI

  • AI-Driven Platforms: Leveraging InCoRe for real-time DMTA cycles, Golden Batch Analytics improving yields by 3–5%, and automated workflows to cut timelines and costs.
  • Enhanced Customer Experience: Gen AI ProposalGenie, SciGenie, and AI chatbots streamline proposal generation and customer interactions.
  • Efficient Digital Labs: Collaboration Companion, Smartsheet, and automated lab instruments optimize productivity and data management.
  • AI-Powered Manufacturing & Cybersecurity: Digital Manufacturing 4.0, AI sourcing, and robust cybersecurity ensure smooth production and secure data protection.

Our End - to - End Services

DISCOVERY

  • Target Identification
  • Lead Generation
  • Target Validation
  • Target Optimization
  • Lead Selection

DEVELOPMENT & CLINICAL MFG.

  • Pre-Clinical
  • Clinical
  • Animal Studies
  • Ph-1
    Ph-2
    Ph-3
  • PR&D, Drug Substance, Drug Product & Analytical

COMMERCIAL MANUFACTURING

  • NDA Filing
  • Product Launch / Phase 4 Manufacturing

ACROSS ALL HEALTH SECTORS HUMAN, ANIMAL & PLANT

  • Synthetic and Medicinal Chemistry
  • Molecular Biology (Gene selection)
  • Protein Sciences (Reagent Generation)
  • ADME & DMPK Studies
  • In-vitro/In-vivo pharmacology
  • Safety Assessment / GLP Tox Studies
  • Antibody Discovery
  • Cell Line Development
  • Bio-Analytical Studies
  • Computational Sciences (Chemistry, CADD, Informatics, AI/ML)
  • Process R&D
  • Analytical R&D
  • All Clone Selection
  • Custom Synthesis
  • Clinical / Commercial scale APIs
  • Intermediates
  • HPAPIs
  • Chemical & Formulation Development
  • Fine Chemicals
  • Tech Transfers
  • Cell Culture Manufacturing
  • API and Cell Culture Manufacturing Commercial Scale supply
  • Small Molecules: 2DL to 12-KL
  • Biologics: 50L – 2KL (scope for expansion till 21KL)
  • Tech Transfers
  • Validation & Stability Batches
  • Small molecules
  • Peptides
  • PROTACs
  • Oligos
  • ADCs
  • Biologics (mAbs)

DISCOVERY

  • Medicinal & Synthetic Chemistry
    Small molecule synthesis including PROTACs, oligonucleotides, peptides, and more reinforced by large-scale library synthesis, cutting-edge synthetic methodologies and advanced analytical techniques.
  • In Vitro & In Vivo Biology
    High-throughput screening (HTS), diverse disease models (oncology, inflammation, CNS, fibrosis, etc.).
  • DMPK & Exploratory Tox
    Comprehensive in vitro ADME, PK/PD, and early safety evaluations.
  • Computational Chemistry & AI/ML
    Leading platforms (Schrödinger, Cresset) for virtual screening, SAR modelling, and hit-to-lead transitions.

INTEGRATED DRUG DISCOVERY (IDD) FOR SMALL MOLECULES

  • Holistic approach with cross-functional teams—chemistry, biology, ADME, DMPK, in vivo pharmacology and AI—to accelerate target ID through preclinical candidate selection.
  • InCoRe (Integrated Collaborative Research) ensures real-time compound management, transparent communication, and fast decision-making.

DEVELOPMENT

  • Process R&D & Tox Batches
    Rapid scale-up (kilo lab to pilot plant), ready for IND-enabling toxicology.
  • Regulatory Toxicology Support
    19,000+ GLP studies; global submission expertise.
  • Pre-Formulation & Formulation
    Address solubility, stability, and bioavailability challenges.
  • Analytical Support
    Advanced instrumentation (NMR, LC-MS) for consistent product quality.

MANUFACTURING

  • Custom Chemical Synthesis
    Large-capacity sites (20L–12.5KL reactors), USFDA-audited.
  • Process Validation & DMF Filings
    Proven track record of USDMF, EDMF, and CEP submissions.
  • High-Potency APIs (HPAPIs)
    Specialized facilities with strict safety controls.
  • Seamless Tech Transfer
    Golden Batch Analytics optimizes yields and reduces costs.

DISCOVERY

  • Antibody Discovery & Protein Sciences
    Stable (CHO DG44, CHO GS) and transient (HEK293, Expi-CHO) cell line development for protein production and specialized screening for novel formats (bispecific antibodies, antibody fragments, fusion proteins, biosimilars).
  • Molecular Biology & Cell Line Engineering
    High throughput expression and mechanistic studies for broad therapeutic targets.
  • In Vitro & In Vivo Pharmacology
    AAALAC-accredited facilities and advanced pre-clinical efficacy models (oncology, immunology, etc.).

INTEGRATED DRUG DISCOVERY (IDD) FOR SMALL MOLECULES

  • Unified Biology & Chemistry Interface for mAbs, bispecifics, ADCs—supporting seamless early-phase process and preclinical development.
  • InCoRe coordinates data sharing and analysis across all functions in real time.

DEVELOPMENT

  • Process R&D
    Flexible upstream/downstream optimization, fed-batch, and perfusion strategies.
  • Regulatory Tox & IND Support
    IND-ready packages, advanced analytics, and robust CQAs assessment.
  • Formulation & Stability
    Customized stress testing and non-GMP/GMP stability studies for high-concentration antibody (mAb) formulations.
  • Analytical & Characterization
    Glycan profiling, potency assays, and structural analyses (LC-MS/MS) and bioassay services.

MANUFACTURING

  • Cell Culture
    Single-use GMP bioreactors (50L–2000L, expandable to 21KL) for clinical and commercial supply.
  • Scale-Up & Tech Transfer
    Efficient transitions from bench to large-scale production with minimal variability.
  • Antibody-Drug Conjugates (ADCs)
    Specialized labs merging advanced conjugation chemistry and biologics production.
  • Process Control & Digitization
    Clean room monitoring, centralized control, remote alerts, and paperless operations with SAP, MES, e-BMR, e-Log, and analytical technologies.
  • Validation & Stability
    Full GMP testing (viral clearance, stability, global regulatory compliance).

GLOBAL REACH & CUSTOMER SUCCESS

400+ clients across US/EU, including 27 Fierce 15® winners and top 10 global pharma.

Robust SCM with real-time tracking and geo-risk mitigation.

Consistent Regulatory Audits: Certified by USFDA, EDQM, PMDA, WHO, among others.

Aragen’s integrated approach, digital platforms, and AI-driven insights have been game-changers for our discovery program—enabling rapid go/no-go decisions and saving critical development time.

Director, Big Pharma Partner

READY TO GO FROM CONCEPT TO COMMERCIAL?

Aragen is your ideal partner for end-to-end drug discovery and development, powered by Digital & AI and bolstered by a global talent pool. Our flexible engagement models and seamless, high-quality services ensure faster, smarter, and more cost-effective progress toward market success.

Your Science. Our Solutions.

Let’s Innovate Together

CONTACT US NOW

Feel free to email us at info@aragen.com or fill out the contact form to discuss how we can accelerate your program from concept to commercial.

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