O’Neal provides total solution biopharmaceutical projects 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. 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
- Biotechnology
- Next-generation biopharmaceutical facility design
- Legacy facility renovation/expansion
- Biotechnology facility design
- Blood products
- Bulk pharmaceutical chemicals
- Cell + gene therapy
- cGMP fill finish facility design
- Dietary supplements
- Food + beverage
- Industrial biotechnology
- Medical device
- Oral solid dosage
- Parenteral fill/finish
- Parenteral therapeutics
- Pharmaceuticals
- Potent compounds
- Probiotics
- Science + technology
- Vaccines
Special Capabilities:
- Integrated planning, design + construction services geared for regulated life sciences industries for grassroots and existing sites
- In-house design expertise in biotech + pharmaceutical manufacturing processes, bioprocess engineering, regulatory compliance, hygienic/aseptic technology, cleanrooms, HVAC + process utility systems, central and process utilities design
- 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
- Process engineering
- Procurement
- Construction
- Process feasibility studies
- GMP equipment design
- Operations improvement
- Process modeling
- Technical consulting
- Operations improvement
