Pioneering Manufacturing for Vaccines & Biologics
Vaccelix Biopharma delivers cutting-edge manufacturing services for sterile injectables, oral solids, antibody-drug conjugates, and clinical tech transfers all under one globally certified GMP umbrella.
Sterile Injectables
Expertise in aseptic formulation and vial filling for biologics and biosimilars.
Antibody-Drug Conjugates
End-to-end ADC production including high-potency containment and QC release.
Technology Transfer
Seamless tech transfers backed by global quality systems and compliance.
Driving Innovation in Biopharmaceutical Manufacturing
Vaccelix Biopharma is a global leader in the contract development and manufacturing of sterile injectables, oral solids, biologics, and antibody-drug conjugates.
With more than two decades of excellence, we combine scientific expertise with flexible, GMP-compliant infrastructure to bring life-saving therapeutics to market. Our client-centric model ensures rapid tech transfer, agile scalability, and uncompromising quality standards across our global facilities.
End-to-End Compliance
Our facilities are fully certified by global regulatory authorities including the FDA, EMA, and WHO.
State-of-the-Art Facilities
Designed for innovation, our cleanrooms, isolators, and high-containment labs meet the most stringent pharmaceutical standards.
Our Accreditations
Our Core Capabilities
Delivering excellence across drug development, clinical supply, and full-scale commercial manufacturing.
Oral Solid Dose
High-throughput capabilities for tablets and capsules, with expertise in immediate, sustained, and modified-release profiles under strict cGMP standards.
Sterile Injectables
Aseptic manufacturing and lyophilization for vials, prefilled syringes, and ampoules—ensuring sterility, stability, and regulatory compliance.
Antibody-Drug Conjugates
Specialized in ADC manufacturing with high-containment suites and precision conjugation processes for targeted oncology and immunotherapy agents.
Tech Transfer
Efficient technology transfer from clinical to commercial scale with robust risk mitigation strategies and real-time process monitoring tools.
Biologics
Upstream and downstream processing for monoclonal antibodies, fusion proteins, and biosimilars, from R&D through to fill-finish and cold chain logistics.
Quality & Compliance
Robust QMS framework with electronic batch records, audit trails, and validated systems supporting regulatory inspections across global markets.
Featured Services
Vaccelix Biopharma offers end-to-end pharmaceutical solutions from early development to commercial supply, ensuring quality, compliance, and efficiency.
Formulation Development
Custom formulation services including oral solids, sterile injectables, and complex biologics, designed to optimize bioavailability, stability, and patient compliance.
- Preclinical formulation screening
- Stability & compatibility testing
- Scale-up for clinical supply
Regulatory & QA Support
Comprehensive regulatory consulting and quality assurance services to ensure global compliance across all product lifecycle stages.
- CTD/eCTD dossier preparation
- Audit readiness & GMP compliance
- Global regulatory submissions
Clinical Trial Supply
End-to-end support for global clinical supply chain including packaging, labeling, storage, and distribution for Phase I to III trials.
- Blinded & randomized packaging
- Cold chain & ambient logistics
- Global distribution network
Process & Analytical Development
Robust process development and analytical method validation using QbD principles, ensuring consistency, scalability, and product quality.
- Upstream/downstream optimization
- Assay development & validation
- Tech transfer-ready documentation