General Consultation

Comprehensive health assessments to guide safe and effective therapeutic planning in drug development.

  • Patient monitoring protocols
  • Preclinical and clinical support
  • Data-driven decision-making
  • Regulatory strategy consultation
  • Risk-benefit analysis
  • Protocol design optimization
  • Therapeutic area expertise
  • Multidisciplinary collaboration support
  • Biostatistical guidance
  • Patient recruitment and retention strategies
Vaccination & Biologics Formulation

Expert handling, development, and GMP manufacturing of vaccines, biologics, monoclonal antibodies, and biosimilars.

  • mRNA, viral vector, and subunit platforms
  • Fill-finish in various presentations
  • Regulatory compliant scaling
  • Cold chain logistics and stability studies
  • Formulation of lyophilized and liquid biologics
  • Cell line development and optimization
  • Immunogenicity and potency testing
  • GMP batch record and QA documentation
  • Technology transfer and scale-up support
  • Analytical method development and validation
Antibody‑Drug Conjugate (ADC) Manufacturing

With 20+ years of ADC experience, Vaccelix offers integrated capabilities from payload synthesis to final drug product.

  • Cytotoxic payload & linker chemistry
  • Conjugation, purification & formulation
  • FDA/EMA-grade cGMP suites
  • High-potency handling capabilities (HPAPI)
  • Scalable linker-payload integration
  • Characterization of drug-antibody ratio (DAR)
  • Stability and shelf-life studies
  • GMP aseptic fill-finish for ADCs
  • QC testing and release analytics
  • Regulatory dossier and CMC documentation support
Advanced Therapeutics Development

End-to-end development for biologics, gene therapies, and mRNA-based candidates targeting oncology, immunology, and rare diseases.

  • Personalized therapy packages
  • Integrated process safety and scale-up
  • Regulatory success strategies
  • Vector design and optimization
  • Non-viral and viral delivery platforms
  • Cell and gene editing technologies
  • In vivo and ex vivo testing capabilities
  • CMC strategy and IND-enabling studies
  • Automated manufacturing and closed systems
  • Translational and biomarker support
Molecular & Biomarker Diagnostics

Precision testing using PCR, NGS, and biomarker assays to support therapeutic development and regulatory dossiers.

  • Genomic and proteomic panels
  • Oncology and immunology markers
  • CLIA/CAP-compliant protocols
  • Companion diagnostic development
  • Single-cell and spatial transcriptomics
  • qPCR, ddPCR, and digital assay platforms
  • Biomarker discovery and validation
  • Bioinformatics and data interpretation
  • Custom assay development and validation
  • Regulatory submission-ready reporting
Analytical & QC Laboratories

Comprehensive services from in‑process monitoring to final product release and stability testing in fully accredited labs.

  • In‑process, release & stability assays
  • Validated method development
  • Digital batch record integration
  • ICH-compliant stability studies
  • Raw material and excipient testing
  • Microbial and endotoxin analysis
  • Potency, purity, and identity testing
  • Extractables and leachables studies
  • Real-time release testing (RTRT)
  • Audit-ready documentation and reporting
24/7 Pharmacovigilance Support

Continuous monitoring for adverse drug reactions and safety signals, ensuring patient protection throughout product lifecycle.

  • Global safety reporting
  • Risk mitigation & mitigation strategy
  • Rapid response coordination
  • Signal detection and trend analysis
  • Regulatory compliance and submissions
  • Case processing and literature screening
  • Safety data management systems (SDMS)
  • Periodic safety update reports (PSURs)
  • Risk communication with healthcare professionals
  • Training and audit readiness support
Telehealth & Remote Advisory

Secure remote consultations and triage support from scientific and clinical experts for urgent decision-making.

  • Real-time expert consults
  • Encrypted video/audio communication
  • On‑demand patient support
  • Remote clinical trial monitoring
  • Digital symptom tracking and reporting
  • Secure data exchange and privacy compliance
  • Multi-disciplinary virtual care teams
  • Emergency triage and escalation protocols
  • Patient education and adherence support
  • Integration with EHR and clinical systems

Ready to Start Your Development Journey?

Contact us to explore how Vaccelix Biopharma can accelerate your path to patients with expert development and manufacturing services.

Contact Us