The cost of manufacturing a drug product batch is an important factor when calculating the overall expenses of a clinical trial and to ensure that you count on sufficient funding to conduct the clinical study.
This article will summarize the main costs involved in manufacturing a drug product.
In addition, we will provide a summarized real-world CDMO quotation example for a small-scale production run of an injectable drug to be used in an early phase oncology clinical trial.
How much does it cost to manufacture a drug product for a clinical trial?
The answer to this question depends on many factors, but usually the production of a drug product batch for a clinical trial may be in the average range of US$300,000 to 1 million.
What are the factors involved in the cost of manufacturing a drug product batch?
There are several aspects influencing the cost of drug product manufacturing.
To get started, it is useful to clarify the difference between two basic elements in a drug: the drug substance —also known as active pharmaceutical ingredient (API)— and the drug product (the final “format” of the medicine).
In this article we are going to specifically focus on drug product manufacturing costs, excluding the cost of developing the API.
The main factors having an impact on the cost of a drug product are: (1) drug type, (2) required infrastructure and equipment, (3) production volume (total number of units), (4) number of production runs, (5) materials, and (6) associated contract development and manufacturing (CDMO) services.
Firstly, drugs come in different physical forms, and different dosage forms have different costs.
For instance, the costs of solutions, powder or granule filled capsules, may be different to the price of making topical products or tablets.
As another example, the cost of producing an injectable drug in frozen liquid format will be lower than using lyophilization.
Although lyophilization has been used for many decades in drug product manufacturing for its ability to stabilize and extend the duration of medicines, interest continues to grow, due, in part, to the growing number of biologic drugs under development.
However, lyophilization is time consuming and expensive.
Therefore, the drug type and the technology selected to produce it can have a significant impact on the overall project cost.
Second, the specific technical infrastructure and equipment needed to fabricate certain drugs will have implications in the manufacturing cost.
For example, sterile fill/finish operations require costly procedures and technologies: liquid-filling equipment, cleanrooms, peristaltic pumps, filtration apparatuses, a lyophilizer (when needed), vial sealers, and biosafety cabinets, among other elements.
Moreover, during fill/finish operations, the environmental air quality must be monitored by passive sampling using settling plates and active sampling using a centrifugal sampler.
Thirdly, as it happens in other sectors, the larger the production order for a product, the lower the price per unit.
In early phase clinical trials (phase I or II), biotech companies may need to fabricate a small number of vials, which tends to increase the cost per unit.
Fourth, every manufacturing run implies costs for setting up, executing, and cleaning the production line and related equipment. Minimizing the number of runs will decrease the overall cost.
Fifth, the cost of raw materials and primary/secondary packaging needs to be considered. The use of standard materials will decrease costs, while the need of customized elements and packaging will increase the expenses.
Finally, there is a wide variety of specialized services associated to the manufacturing of a drug product (e.g. quality control, analytical testing, batch certification and release), so the need for such services will add up cost to the bill.
As we can see, the production costs of drugs can really vary a lot, so it becomes practically impossible to determine a default price.
Manufacturing a small batch of drug product for a clinical trial: A real-world quotation example
Let’s consider a biotech company planning a phase I-II clinical trial in oncology, with the requirement of manufacturing 3,000 vials of an injectable drug (sterile fill and finish).
In the following lines we will summarize the main cost sections involved in this drug product manufacturing project.
It is assumed that the biotech company will subcontract the drug product manufacturing project to an external CDMO.
1.- Project Planning & Management
Initially, the CDMO team will have to work on planning the project.
This initial stage will include tasks such as defining milestones and timelines, allocating human resources, initial meetings, and defining the responsibilities of each party.
Subsequently, a project manager will be responsible for coordinating and supervising the project.
Project Planning & Management Total: $35,000
2.- Supplier Management
The CDMO will work on the definition of the suppliers required for the project, namely the vendors providing elements such as the active pharmaceutical ingredient (API), excipients, and packaging.
These tasks may include the assessment and qualification of new vendors.
Supplier Management Total: $4,000
3.- Drug Product Analytical Development
Regarding drug product analytical development, the following activities are assumed: drug product assay and high performance liquid chromatography (HPLC) method transfer, as well as bioburden and sterility method validations.
Drug Product Analytical Development Total: $40,000
4.- Batch Manufacturing Activities
This section comprises the drug product batch manufacturing tasks, which include:
- Filter validation to ensure that filters are working properly ($35,000)
- Creation of batch records ($20,000)
- GMP batch production (vial manufacture and filling) including raw and packaging materials ($120,000, at $40.00 per vial x 3,000 vials)
- Stability studies and analyses (e.g. pH, color, impurities, among others) at different time points ($55,000).
Batch Manufacturing Activities Total: $230,000
TOTAL PROJECT COST = $309,000
The cost of manufacturing a drug product depends on several elements such as type of drug, required technology, production size, manufacture runs, raw and packaging materials, and related CDMO services.
For early stage clinical trials (phase I-II), which are clinical studies of smaller size, the investment required in drug product manufacturing may be in the $300,000 to $500,000 range.
For larger trials in later stages of development (phase 3 studies with more patients), the investment may increase up to and beyond $1 million.
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