Contract – Manufacturing Service Agreement
In this article, I have summarised key elements of CDMO service agreement. 🧾
These elements can ensure that the manufacturing service agreement is clear, thorough and provide a structured legal framework for trustful partnership between the service provider (manufacturer) and its clients.
It covers all critical aspects from definitions and services to termination and dispute resolution. 🗄️
Cost – Process Development and Manufacturing Cost
Drug manufacturing costs (or CDMO prices) are highly secretive and treated as confidential information. Therefore, many researchers try to estimate costs and prices of drug products for fulfilling various interests (also as well as investment purpose).
The cost (CDMO price) are varied depending on modalities and stages of development mainly due to complexity of processes and characters in titers/yields – typical costs of large molecules manufacturing can be between 5 times and 10+ times higher than small molecules therefore. This can also be much higher if it is more complicated modalities such as multi-specific antibodies, ADC or CellandGene therapies (as well as IP).
Overview of common cost estimates for biopharmaceutical products are presented in this article.
Price – Raw Materials, Safety Stocks and Excessive Stocks
💵 The price of biopharmaceutical manufacturing services in CDMO is determined by complex formula. Main criteria for the pricing formula is mainly based on i) project plan, ii) services and additions in the services, iii) raw materials and safety stocks, iv) batches/products and consumables, v) other fees.
In this article, I have covered one of the most critical element in pricing – raw materials, safety stocks and inventory management (incl. forecasting).
Each CDMO has tailored strategies in Procurement and Supplier Quality to ensure the availability and quality of raw materials and efficient management practices. These approaches create added value and differentiate among other CDMO companies.
Pricing – General Pricing Principles in CDMO
💵 CDMO pricing criteria for biologics development/manufacturing services are designed and proposed based on variety information such as questionnaires and series of data/discussions as progressed.
Pricing criteria in practice is also varied depending on CDMO’s capabilities and/or service offerings whether they are owned or outsourced, or whether they are CDO, CMO or CRDMO, etc. 🧬 to 💉
In this article, a common pricing criteria for many global CDMO companies are summarised and compared. Also shows Real life examples of how each CDMO company is utilising this criteria based on their capabilities. 🏭
Contract – CDMO Payment Terms and Risk Management
After realising services required either or both development (CDO) and manufacturing services (CMO), two parties ensure the payment terms and plan the payment for continuous flow of services and products to be received on schedule.
Understanding payment terms are equally important for both clients and CDMO service providers: the service agreement (contract) contains specific conditions and requirements for payment, which secure development, production and mitigate potential risks in both side.
This article covers key provisions for payment plan and risk management for both CDMO and its client.
Price – CDMO Services By Stage
CDMOs offer various services from project initiation to batch production and regulatory services, and these services can also be varied by stage of drug development. Well-established CDMO, therefore, offers various services in each stage suitable for the project’s success and to ensure regulatory requirements. 📝
🥼 Analytical services and testing services are essential for drug development and chemistry manufacturing and controls (CMC). Almost all CDMOs offer analytical testing services either tailored or as one package.
Whether they are offered as one package for End to End (E2E) services or tailored services by stage, price of materials, labours, facilities and the services are accumulating and building up the total price of the CDMO services. 💵
This article provide comprehensive summary and key elements of CDMO services offerings.