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Pharma Manufacturing Article: Optimize Cost of Goods in Cell Therapy Manufacturing

By: Jeff Odum, CPIP | Practice Lead, ATMPs & Biologics, Genesis AEC

Decisions made during the conceptual design of a manufacturing asset for cell therapy products (CTP) have consequential impacts on not only facility capital costs, but also on the cost of goods (COGs). During clinical trials, there is tremendous focus on trial costs as companies move into phase 3 trials. Decisions made years before in facility design can impact these per-patient values more than many might think.

The design of a manufacturing process for any biopharmaceutical product involves a proven methodology that includes criteria such as operating costs, capital investment costs, and manufacturing reliability and efficiency.

Costs for raw materials, reagents, starting materials, labor, utilities and consumables will be driven by market conditions, and there is little impact that can be influenced to reduce/improve this market reality. But the facility attributes that impact day-to-day operational costs and manufacturing efficiency, once established, will become the baseline. Speed to market, flexibility and efficiency, and regulatory qualification/compliance are impacted as COGs are baselined.

Developing a COGs model

Implementing COGs analysis during early phase facility planning sheds light on areas of operational cost risk, future per-patient trial costs impacted by facility attributes and identification of options for consideration in equipment selection and facility design. By looking at COGs distribution for each clinical phase, it can be easy to see where facility design decisions have the greatest impact. The costs from personnel, materials/supplies, equipment and facility attributes significantly impact overall operational costs.

Developing COGs values that are specifically driven by the attributes of the process-facility relationship will focus on a set of inputs and outputs that have a direct day-to-day impact on operational costs and manufacturing efficiency. The key is to have a tool that will provide the necessary data for evaluation while also making the data accessible during the design phase of the project. As design attributes change, so will the data. The tool should be ‘user friendly’ and easy to implement.

The inputs required to evaluate manufacturing costs should include:

  • Personnel requirements
  • Unit operational data
  • Batch size
  • Operational scale
  • Qualification data
  • Materials and consumables

For early phase design development, the focus will be on defining the established fixed costs that can be supported with available data. This will include:

  • Equipment sizing/vendor data: In the model process, all unit operations are performed in single-use components. This is driven by scale of operation, flexibility, and level of automation. For this model, unit operations are assumed to remain manual-focused during the clinical manufacturing phases, as many CAR-T operations are today. Key information would include: product protection via equipment solution (BSC/isolator); cell processing via cell enrichment, cell washing; concentration; filling; and cryo storage.
  • Utility consumption: Load calculations based on facility attributes such as HVAC unit sizing/zoning and average energy cost (localized).
  • Area sizing/classification in regards to energy usage intensity and operations schedule
  • Cost of consumables — such as bags, micro beads, bottles, pipettes and tubing — based on target manufacturing outputs.

There will also be a need to identify key assumptions necessary to complete the COGs model. You will need to factor in batch targets based on manufacturing time durations, testing requirements, headcount full-time equivalent, energy costs, annual maintenance costs and unscaled facility costs (tax rates).

Since many CTP processes are not yet considered ‘robust’ due to their lack of manufacturing support data, the question around COGs is not always given its appropriate emphasis during early phase design activities — but it should be.

Originally published by Pharma Manufacturing.

Glossary

  1. Cell Therapy Products (CTP): A form of treatment where cellular material is injected, grafted or implanted into a patient. This technology is used in fields such as oncology, cardiology, wound healing, and regenerative medicine.
  2. Cost of Goods (COGs): The total production costs associated with creating a product, including raw materials, labor, and overheads.
  3. Phase 3 Trials: The phase of clinical trials where the new treatment is tested on a larger group of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the intervention to be used safely.
  4. Biopharmaceutical Product: Therapeutic or diagnostic products, or vaccines, that consist of natural biological substances, such as proteins and nucleic acids.
  5. Raw Materials: Unprocessed material used in the manufacturing process.
  6. Reagents: Compounds or substances added to a system to cause a chemical reaction or test if a reaction occurs.
  7. Starting Materials: The raw materials, reagents, and solvents intended for use in the production of either an intermediate or an active pharmaceutical ingredient (API).
  8. Unit Operational Data: Data related to the performance of individual operations within a process.
  9. Batch Size: The quantity of goods produced in a single manufacturing run.
  10. Operational Scale: The size or capacity at which a firm opts to operate its processes.
  11. Qualification Data: Data that demonstrates that a process or a system performs as intended and meets the specified requirements.
  12. Equipment Sizing/Vendor Data: Information related to the size and capacity of equipment needed for manufacturing, as well as data related to the vendors of such equipment.
  13. Cost of Consumables: The expense related to items such as electricity, water, gas, and other elemets used in the manufacturing process that get used up or converted.
  14. CAR-T Operations: Processes involved in the manufacturing of Chimeric Antigen Receptor T-cell (CAR-T) therapies.
  15. Analytical Testing: Lab-based testing to understand and evaluate the physical, chemical, and biological properties of a product.
  16. Therapeutic Cost-Benefit Analysis: An evaluation of the cost of a treatment versus the benefit it provides to the patient.

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About Genesis AEC

Genesis AEC – an award-winning consulting, architecture, engineering, and construction management firm – has partnered with life sciences companies for more than 25 years to complement the scientific expertise of our clients as they usher in the next generation of life-saving therapies, treatments, and technologies. Whether it’s providing AE support for existing sites; commissioning, validation, and qualification (CQV) for specific processes or equipment; or turnkey design-build solutions, our team blends sound science and technical expertise with quality assurance and safety measures to deliver unparalleled results.