top of page
Manufacturing

Manufacturing

Dedicated project teams, agile production structure, flexible scheduling, optimized material usage

Manufacturing validation batches quickly

ISO and GMP-qualified labs, validated facilities, segregated zones, controlled flows, transparent long-term partnerships

Finding a reliable GMP partner

Expertise in mammalian/bacterial systems, recombinant proteins, antibodies, custom process adaptation, precise mixing technologies under GMP

Managing complex biomolecules

Optimized processes, efficient resource use, trained operators, controlled labelling/capping, full traceability

Reducing costs while ensuring precision

Qualified analytical instruments, ALCOA-compliant data, full GMP compliance

Ensuring data reliability and compliance

Turning Your Challenges into Results

From Lab to Line: Manufacturing Success

Rapid, flexible & reliable production

High-quality, compliant processes

Expert handling of complex biomolecules

Your benefits with Helio 

Delivering Rapid, High-Quality, & Traceable manufacturing

Choose Helio for ...

Comprehensive Manufacturing

  • Validation batches & project management

  • Flexible production & capacity at different scales, flexible production slots, adaptable scheduling

  • Reliable GMP partner support Transparent, long-term outsourcing partnerships

  • Process efficiency
    Optimization to reduce material and cycle costs, efficient use of shared resources and infrastructure

  • Customer focus
    Dedicated project teams, agile structure

Manufacturing & Operational Agility

  • GMP-compliant facilities
    with ISO 8 cleanrooms

  • Qualified labs, and controlled environments

  • Contamination control
    HEPA filtration, monitoring, and traceability systems

  • Regulatory compliance
    FDA, ALCOA

  • In-house QC lab
    with calibrated instruments

Facilities, Compliance & Risk Management

  • Bacterial transformation, cloning & selection

  • Cell culture: Mammalian and bacterial

  • mAbmanufacturing & purification:
    GMP-compliant workflows

  • Complex biomolecule production: recombinant proteins and antibodies; custom process

  • Mixing & formulation: Homogeneous, reproducible blending of buffers, media, and GMP solutions up to 20 L, including aseptic preparation

  • Filling & packaging: Auto/semi-auto filling, manual handling for delicate or precise items, with verified manual labeling and capping

  • Traceability & adaptability: GMP-compliant custom labels with verification, full lot traceability, and flexible manual handling for various tubes and caps

Technical Expertise & Product Handling
bottom of page