Modeling and simulationWe utilize mechanistic models to build digital twins of your equipment and processes. Mechanistic models (first principle analysis) are based on the fundamental laws of physics and chemistry, in contrast to statistical models. We develop multiscale and multidimensional (spatial and temporal) simulations for multiphysics and complex problems.Procegence’s business model is Simulation-as-a-Service. We are equipped with diverse commercial software platforms, our proprietary codes, and high-performance computers (on Cloud or our scientific computers). This enables us to deliver comprehensive end-to-end solutions for your process, from materials to equipment to products. Our engagement will provide you with on-demand access to our modeling tools and expertise. These on-demand modeling and simulation services eliminate the cost and resource burden of building up an in-house modeling team. We believe in co-creation and we work hand-in-hand with you to provide client-oriented purposeful solutions to meet your specific needs.
ConsultingWhether you are aiming for a new, advanced manufacturing technique or revamping your process, we are available to help you with techno-economic analysis, retrofitting, equipment characterization, integration, enterprise-level optimization, and regulatory concerns. Our team has a diverse background and many years of experience in different industries, regulatory, and academia and research and can provide multidimensional perspectives for a smooth transition, or decision making. In addition, our broad network of partners and collaborators can help you with customized solutions or selecting from already developed off-the-shelf tools.
Regulated industries, such as Pharmaceutical and Biopharmaceutical industries, have to comply with tight regulations on Chemistry, Manufacturing, and Control (CMC). The process development activities, changes in the process or product, adopting a new technology, or a modification of the control methods should be submitted to the authorities for evaluation and approval.
Procegence supports clients with the readiness and preparation of regulatory materials along the life cycle of the process and product on:
- Control strategy, risk evaluation, and mitigation strategy
- CMC supplements, product-life cycle, and CAPA
- Post-approval changes (SUPAC), new submissions, and technical reports
- Complying with all active guidelines, CFRs, and ICH Qs
- Identification of quality target product profile (QTPP), to ensure the finished product’s quality, safety, and efficacy
- Identificatying and optimizing correlation of CMAs~CPPs~CQAs
- Implementation of the control strategies and control space within design space
- Continual improvement and quality report submissions
We will work with your product, your process, your data, and your personnel. Included in our services are the following:
- knowledge transfer
- the training of your personnel from fundamentals to advanced aspects of the modeling and simulation
- the training of your personnel to effectively utilize the tools to improve their efficiency.
Whether the training will be used for internal development or as further extension to future applications, our expert team is ready to train your team on different aspects of the digital transformation. This includes parameter estimation, manufacturing, and regulatory submission. We provide virtual and on-site training along with the workflow, and on deliverables to create an enterprise-level knowledge that your personnel can effectively harness.
Process development, equipment selection, scale-up, characterization, and process integration are complex and challenging tasks, traditionally involving a multiciliary team, experimentation, and time consuming and resource extensive activities. The knowledge-based approach and mechanistic modeling to capture multi-scale and multiphysics phenomena, in virtual mode, can streamline activities and make the endeavor faster and more efficient.
We utilize our diverse tools and in-depth knowledge to create purpose driven solutions and tailored tools to expedite process development activities, optimize scale and conditions, and perform technoeconomic evaluations. The virtual multidimension DoEs and in-silico case studies will be used to scan a wide combination of process conditions, material attributes, equipment size and design, and quality attributes to optimally design the best process in a short time and in a comprehensive fashion. The digital tools provide the opportunity to scan many different equipment designs and process conditions that are not possible to try in an experimental lab. The risk analysis and control strategies set-up and design space will be other direct outcomes of the activities that can support your QbD practices.