Biopharm

Offering full-service site evaluation, master planning, architectural design, engineering, procurement, and construction capabilities for GMP manufacturing, research and development, process support, facilities and utilities, O’Neal provides a total solution. Added to these capabilities is in-depth regulatory compliance with FDA and CBER regulations, and cGMP and ISPE best practices.

Focus Areas:

  • Aseptic manufacturing
  • Biopharmaceuticals
  • Blood products
  • Bulk pharmaceutical chemicals
  • Cell + gene therapy
  • Dietary supplements
  • Industrial biotechnology
  • Medical device
  • Oral solid dosage
  • Parenteral therapeutics
  • Pharmaceuticals
  • Potent compounds
  • Probiotics
  • Vaccines

special capabilities:

  • Integrated planning, design + construction services geared for regulated life sciences industries
  • In-house design expertise in biotech + pharmaceutical manufacturing processes, regulatory compliance, hygienic/aseptic technology, cleanrooms, HVAC + process utility systems
  • Long-term industry experience + specialized knowledge, to handle cGMP facility delivery from initial planning + concept development through detailed design, procurement + construction
  • Facility delivery for complex, technology + compliance-driven design requirements through full-service capabilities to operate within a cGMP environment

Services:

  • Planning
  • Site selection support
  • Facility programming
  • Conceptual design
  • Preliminary engineering
  • Detailed design
  • Procurement
  • Construction
  • Process feasibility studies
  • GMP equipment design
  • Process modeling
  • Technical consulting
  • Operations improvement

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