Manufacturing Strategy
Defining your manufacturing strategy can be a complex task with many variables impacting the outcome. Our team of experienced consultants can help you with various aspects of your strategy planning, including:
Build or Buy Analysis
A critical decision in the development of a manufacturing strategy is whether to ͞build or buy manufacturing capacity. This may need to be assessed and revisited at each stage of clinical development and for different products.
We have the experience and independence to assist with this decision and will ensure the criteria for ultimate selection fits with your organisation’s overall business objectives. There are many factors to consider in making the choice, not all related to cost, although availability of capital is often a key driver early in a company’s lifecycle. Other factors include protection of the process particularly if no process or product IP is involved, extent of the overall product portfolio, risk of clinical failure, required timing of manufacture, availability of in-house resources and manufacturing readiness of the process.
We have experience over multiple projects of assessing, selecting and managing contract manufacturing capacity in the EU and US in different configurations to suit different needs including academic GMP Contract Manufacturing Organisations (CMOs), commercial CMOs and hotel-type CMOs. This gives us up to date generic pricing including both the CMO and the client elements required to achieve successful technology transfer and ongoing successful production. It also gives us knowledge of the market competence for different kinds of cell and gene therapies.
CMO Search and Selection
We have significant experience of helping clients in the selection of CMOs. We take a structured approach, comparing CMOs using a ranking system based on clients’ needs. In this system, we rank and compare the responses to our clients’ key requirements, questions and quotations resulting in an objective comparison of potential CMOs. If needed, we can perform part of the CMO selection process so that clients’ can remain anonymous until later stages. After selection, we can assist or advise in contractual and quality agreement negotiations and technology transfer to the CMO
Technology Transfer Management
We provide clients with the technical guidance and project management for transfer of technology to the CMO. Technology transfer typically consists of the following phases:
- Preparation of a complete technology transfer package and advice on the content
- Kick-off meeting using a proven methodology to run through specifications, materials, process, QC and equipment requirements per unit operation followed by theInformation exchange phase
- Demonstration of the process at the client’s premises and observation of the process at the CMO’s premises
- Documentation preparation,material ordering and arrangement of starting materials, method transfer
- Qualification or validation of QC assays. Qualification of operators, process and aseptic procedures
- Clinical readiness.
During each phase we help our clients define clear deliverables and identify and provide solutions to any problems, so the best outcome is achieved.
Cost of Goods (CoG) Analysis
We can use our CoG analysis to forecast the cost of manufacturing your ATMP. This can include all the costs from donation to administration or it may focus on specific elements within the manufacturing process. We use a cash flow basis which includes all the major costs (facility, staffing, materials and production volumes) and how they might vary over time. In this way we can predict the impact of proposed changes to manufacturing steps and production volumes. A particular strength is our ability to gather costs from across our multi-disciplinary team; for example capital and staffing costs from the project and process engineers, direct costs from the cell therapy consultants and the PD lab, and regulatory costs and risks from our compliance experts.
We explore potential cost changes using sensitivity analysis and this can be used to guide process development and manufacturing strategy decisions as well as providing improved cost certainty for the business plan. The sensitivity analysis can also be used to model the impact of some risks and their potential mitigation. Periodically, the CoG analysis can be used to reconfirm projected costs as the investment proceeds.
Due Diligence
eXmoor can strengthen your diligence team with expertise in CMC, Quality and process engineering to help you get a better insight in the value connected to the opportunity as well as the risks and costs. We can help writing the diligence report and assist in further development of the opportunity.
We can add value by assessing the GMP compliance of a production process and plant, the scalability of a production process towards the projected market demand, the current capacity of the production facility, providing a gap analysis of the diligence package provided and estimate the CoG for production, testing and distribution. This will help you to better understand the opportunity as well as the work to be done and the associated costs.
We can provide you with a high level process development plan based on the assessment of the process, an overview of the changes required to the production plant to meet capacity demands and/or GMP guidelines, an estimate of costs and timelines associated with the proposed plans, a projection of the CoG of the product in the adapted process, a strategy to close the gaps observed, with a priority list, time needed and associated costs.