Price – CDMO Services By Stage

CDMOs offer various services from project initiation to batch production and regulatory services. Depending on a company’s scope and capability, it can be CDO (offering development services), CMO (manufacturing services) and CDMO (for both).

1. CDMO Services

Services offered by C(D)MO can be also varied by stage of drug development. These stages are mainly in three criteria i) Development stage, ii) Clinical stage, and iii) Manufacturing stage.

Well-established CDMO, therefore, offers following services in each stage:

Development Services

• Project Initiation, Technology Transfer, Process Development, Analytical Method Development, Pre-formulation Testing, Stability Testing, Pilot Production, Batch Production

Clinical Services

• Clinical Trial Material Testing, In-Process Control, GMP Batch Release Testing, Stability Testing

Manufacturing Services

• Batch Production, Analytical Testing, Batch Release, Routine QC Testing, Continuous Stability Testing, Regulatory Compliance/Filing

Depending on the services above, whether they are offered as one package from End to End (E2E) or tailored services by stage, price of materials, labours, facilities and other services are accumulating and building up for the total price of the C(D)MO services.

Also, see my previous articles regarding price/costs of CDMO: CDMO Cost Elements and Materials/Safety Stocks.

2. Analytical And Testing Services

Other than materials, labours and facilities, there is a key element for CDMO price – analytical and testing services.

Analytical and testing services are essential services for drug development and chemistry manufacturing and controls (CMC) and almost all CDMOs offer analytical testing services either tailored or as one package.

These tests are to ensure the quality and compliance of the biopharmaceutical products.

Analytical and testing services are also differentiated by stage and come with the activities mentioned in 1. CDMO Services above.

Typical analytical and testing services are listed below and used in the stages. Testing criteria are defined by clinical and regulatory requirements, ensuring compliance and quality at each stage

• Analytical Method Development: Essential for early-stage development to establish accurate and reproducible analytical methods. (reference)

• Stability Testing: Conducted at both early and late stages to ensure product stability over its intended shelf life. (reference)
• Release Testing: Performed at the late stage to confirm that the final product meets all required specifications before being released to the market. (reference)
• Process Validation and Control: Critical at the late stage to ensure the manufacturing process is consistent and produces a high-quality product. (reference)
• Comparative Studies: Ensures consistency between different production batches and manufacturing sites.

By stage, CDMOs are typically offering:

Development Stage

• Analytical Method Development, Characterization Studies, Stability Testing, Release Testing

Clinical Stage

• Clinical Trial Material Testing, Clinical Release Testing, Stability Testing

Commercial Stage

• Routine Quality Testing, Stability and Release Testing

Each testing uses variety methods to ensure fulfilling regulatory requirements and client specifications. Skilled CDMO can design and offer optimal testings and optional testings based on regulatory guidelines where applicable.

Here is an example of testings offered by CDMO in each stage:

Development Stage

• HPLC, ELISA, PCR, Bioassays, Cell-based Assays, Molecular Characterisation, Chromatography, Electrophoresis, Mass Spectrometry, Dissolution Testing, UV-Vis Spectroscopy, Karl Fischer Titration

Clinical Stage

• Sterility Testing, Endotoxin Testing, Protein Concentration Assays, Viral Safety Testing, Mycoplasma Testing, Peptide Mapping, Bioburden Testing, Subvisible Particle Analysis, DNA Sequencing, Preservative Efficacy Testing, pH Testing, Osmolality Testing

Commercial Stage

• Potency Assays, Impurity Profiling, Residual Solvent Analysis, Aggregation Analysis, Particulate Testing, Spectroscopic Analysis, Glycan Analysis, Host Cell Protein Assay, End-product Testing, Assay Testing, Heavy Metals Testing, Stability-Indicating Assays

Based on a project scope and regulatory requirements mainly, ability of CDMO’s analytical services and testing services is probably one of the most important key factor to have a right partnership and value for quality.

If you would like to understand more about services how top CDMOs differentiate themselves in the crowded market, feel free to contact me.

About the author

Juha Kim is a CDMO business consultant and business operations strategist. Equipped with latest studies and business practices, he is building frameworks in the world’s renowned CDMO companies based on his experiences leading various projects in Lonza as a Director, Operations Finance and Business Development Korea roles during the time.

He is also a founder of Korea-Switzerland BioPharma Network (KSBPN) and Korea Pharma Biotech Directory (KPBD) to help establishing business opportunity leads in both directions.