Process Development and Process Engineering
In our integrated approach to find solutions to out clients' challenging problems, we place significant emphasis on fundamental, model-based process development and engineering at all stages of the drug development continuum.
This enables the ability to address the interaction of formulation physicochemical constraints and process definition to minimize development timelines and risks early on. In late stage development, these process development models are used to ensure optimization of efficient, robust processes. These models allow rational risk assessment and identification of critical to quality attributes and parameters, which is the basis for Science-of-Scale (scale-up and scale-down with reduced experimentation) and Quality-by-Design (QbD).
At our engineering pilot-plant facility, we offer extensive unit operation experience for both traditional and enabling dosage forms. We apply our model-based process engineering to spray drying, extrusion, immediate-and controlled-release tableting, multiparticulate and other processes.
- Process development
- Emphasis on the interaction between formulation physical science and engineering fundamentals in an approach that saves time, reduces the use of active compound, and minimizes risk
- Testing capabilities at a range of equipment scales, from milligram-scale feasibility testing to precommercial testing on large-scale equipment
- Spray drying
- Single and bi-layer tablet compression
- Functional tablet coating
- Fluid-bed coating and granulation
- Melt-spray-congeal processing
- In-depth modeling, including the following deterministic and statistical approaches
- Computational fluid dynamics (CFD)
- Custom predictive biomodels
- Dimensional analyses, enabling variable reduction and scale-up correlations
- Statistical approaches such as “design-of experiments” and latent variable modeling
- Design, modification, and manufacture of custom equipment
- Technology-transfer assistance to client manufacturing sites, contract sites, or our own current Good Manufacturing Practice (cGMP) manufacturing facility
- Process support for clinical-trial manufacture to commercial-scale manufacture
Bend Research offers extensive state-of-the-art equipment for cGMP manufacturing. Review our list of formulation development/process analytical equipment.
Learn more by downloading some of our recent publications:
- Graham, L.J., R.D. Taillon, J.M. Mullin, and T.D. Wigle, “Pharmaceutical Process/Equipment Design Methodology Case Study: Cyclone Design To Optimize Spray-Dried-Particle Collection Efficiency,” Comput. Chem. Eng., 34:7 (2010) 1041-1048
- Dobry, D.E., D.M. Settell, J.M. Baumann, R.J. Ray, L.J. Graham, and R.A. Beyerinck, "A Model-Based Methodology for Spray-Drying Process Development," J. Pharm. Innovat., 4:3(2009)133-142.
Contact us for more information on our process development and engineering capabilities.