Taking a novel process or product from laboratory research to GMP manufacturing at scale is a complex task. Application of process engineering fundamentals to any process is necessary to meet the often, strict criteria for safety, capital/operating costs, capacity, performance and sustainability.
Our team of highly experienced engineers can lead the process and utilities design on behalf of our clients and offer continued support throughout the project lifecycle. We have extensive experience in specification, design, commissioning and qualification gained in the pharma, biotech, cell and gene therapy industries.
We are currently supporting our clients in:
Capacity Scheduling and Optimisation
Project feasibility, facility and equipment strategy is informed by the definition of processes. We have developed methods for high-level capacity analysis to estimate the number of cleanroom suites that are required and detailed scheduling to take a deeper dive into equipment and people utilisation to identify and resolve bottlenecks. We aim to do this in a way that can be understood by all project stakeholders.
Single-use Technology and Stainless-steel System Implementation
Our engineers have extensive experience in the implementation of reusable and disposable technologies and the retrofit of existing facilities that can take advantage of the ever-evolving single-use technology sector. Cost benefit analysis, operational, utilities requirements, biocompatibility and supply chain experience are all leveraged to help our clients decide on which strategy is most suited for their manufacturing facility.
We support the definition, selection, procurement and commissioning of the whole range of process equipment from lab instruments including upstream and downstream unit operations, EMS (Environmental Monitoring Systems), clean utilities generation and distribution and isolator technologies.
Process Safety, Risk Evaluation and Mitigation
Meaningful risk assessment requires the input of Subject Matter Experts. Our process engineers have a background in process and operational safety, process economics and experience of the likelihood of failures due to equipment and/or human factors. A pragmatic approach with the GMP compliance team ensures that risks are identified early on and thus mitigations are inherent in the subsequent design.
Clean Utilities, CIP and SIP Specification and Qualification
Where process scale or compatibility requires the need to select in-house clean utilities generation and re-usable equipment, then our combined experience over hundreds of projects in traditional pharma and biotech can be drawn upon. Our engineers give courses on pharmaceutical waters and keep up to date with ISPE guidance as well as pharmacopeia requirements via our QP colleagues.
Effluent Treatment Systems
With specialist experience gained from designing and realising high containment facilities and processing involving genetically modified organisms, potentially infectious patient-derived materials and animal health products, we can provide containment audit, specialist vendor selection and segregation advice for air, solid and liquid treatment systems.