Advanced Technologies
NGT BioPharma Consultants utilize an integrated consulting services model to provide contemporary solutions that help solve the complex technology process and platform challenges that are often encountered in the biopharmaceutical development and manufacturing of small molecules and biologics (Mabs, duobodies, proteins, cell therapy, gene therapy, and new modalities).
Our technical experts and strategy consultants work in partnership with a network of industry-leading equipment designers/fabricators, A&E firms, and academic research institutions to design, develop, and support the deployment of transformative analytical, process, equipment, and facility platform technologies. Our consultants also work seamlessly with other functional areas, such as Nonclinical, Clinical, CMC, Regulatory, and Quality/Compliance to provide services that include, but are not limited to, the following:
- Process, chemical, and mechanical engineering
- Small footprint, low-cost manufacturing design options
- Development and deployment of Process Analytical Technologies
- Manufacturing control systems
- Modular/batch hybrid facility concepts and design
- Flexible, reconfigurable, and on-demand facility concepts
- Multi-step API and drug product continuous manufacturing design, deployment, and validation
- Factory digitalization strategies
- Batch-to-continuous process conversion
- Process economics and industry benchmarking
- Facility, technology, and product due diligence
- PAT and continuous process regulatory strategy & submissions
- Process continuity for regulatory approval
- Additive manufacturing, e.g., 3D printing of pharmaceuticals
- GXP documentation development and/or review (e.g., procedures, protocols, reports, analytical methods, specifications, batch records, training materials, master plans)
