Process development begins with selecting the optimal process and enabling technologies during product design and proceeds through each stage of development, including scale-up from bench and pilot scale through to commercial manufacture under cGMP conditions.
We provide comprehensive development support and meet rigorous product specifications and ensure efficient process intensification to optimize manufacturing costs. To meet these needs, Mivado GlobalPerformance provides comprehensive drug process development to continually improve your operational efficiency.
Our multi-disciplinary team are experienced in process modeling, pilot process and analytical development, manufacturing technical support for commercial manufacture focused on biologics including cell, gene and vaccine production. We assist client organizations with the full range of clinical, upstream, downstream, and fill-finish process development.
We assist with upstream process development services including:
- Conceptual design and modeling of process train from cell banking through harvest for transfer and scale up
- Host cell line development and cell culture development
- Media development and feeding strategy optimization for titer improvement
- Implementation of continuous cell culture systems based on perfusion
- Set up of harvesting/cell separation processes using filtration or centrifugation
- Identification and evaluation of critical process parameters (mixing, shear, and mass transfer)
- Development of single use systems for legacy and cell therapy processes
We provide downstream process support including these areas:
- Conceptual design and modeling of purification process train from harvest through bulk for tech transfer and scale up
- Design of chromatography skids capable of in-line dilution and real time chromatographic data analysts
- Buffer optimization and delivery
- Resin selection and optimization including static/dynamic binding studies
- Development of column packing procedures for compressible and incompressible resins
- Development of continuous chromatography based on expanded bed systems
- In-process controls methods development and validation including filter integrity testing
- Identification and evaluation of critical process parameters for chromatography, TFF, and bulk substances
- Implementation of viral inactivation and viral filtration for bulk including legacy processes
We also assist with fill-finish process development including the following:
- Integration of isolators for integrated fill line including decontamination cycle development/validation
- Design and transfer of freeze-dried (lyophilized) drug products
- Development of depyrogenation cycles
- Evaluation of key lyophilization process parameters such as eutectic /collapse temperatures
- Evaluation of pump-based and time pressure-based filling processes
Material generated is used to develop your early-stage material for analytical, formulation and lyophilization cycle development. Process Development works with Analytical Method Development (AMD) to determine your program quality attributes, design stability programs for process intermediates, and define your process hold steps. Our Process Development team determines the Critical Quality Attributes (CQAs) and Critical Process Parameter (CPPs). We design your processes to optimize yields and remove impurities with minimal steps and optimal recovery.
