Contract Development Manufacturing or Contract Research & Manufacturing Services Organizations take-over more and more activities from “traditional” Life Sciences companies. CDMO services span from Drug Formulation Development, Clinical Trial Services, API production, drug product production to packaging operations.
This ongoing consolidation and M&A activities in the CDMO market requires from CDMOs to be / become not only more service-oriented but especially:
In order to become “fit-for-future” many CDMOs started to create their Digital Agenda to transform their organization for the upcoming years.
We recommend to build the foundation first by automating enterprise processes. An integrated ERP system like SAP S/4HANA enables to computerize all enterprise processes like Procurement of raw materials, production of drug substances and drug products, delivering the produced drugs to the pharmaceutical customers.
The Tenthpin CDMO Model is a starter-package for all CRO and CDMO companies from pure Research & Development organizations, Clinical Trial enterprises, to full-fletched R&D -Manufacturing - Distribution organizations.
1. Client Interaction / Integration Models
There are multiple ways for CDMOs to interact with their clients. A key decision driver for setting up the right Interaction Model is the depth of collaboration/integration with the clients. Based on Tenthpin experience most clients and CDMOs share certain data like customer forecasts (from clients) or production capacities (from CDMOs).
2. Enterprise CDMO Process Model
Tenthpin developed an Enterprise Process Model for CDMOs. This Process Model spans from level 0 to level 5 (activity level) covering all enterprise process areas: Project-Start-to-Finish, Purchase-to-Pay, Plan-to-Produce, Inspect-to-Release, Inspect-to-Repair, Order-to-Cash, Store-to-Ship, Finance-to-Report and Hire-to-Retire. In all those process areas typical processes for CDMOs are modeled.
3. SAP S/4HANA CDMO Model Enterprise
Based on the CDMO Best Practices Process Model (described in 2. above) Tenthpin has a pre-configured SAP S/4HANA system covering all typically required CDMO processes including master data like material master, Bill-of-Material (encompassing all manufacturing stages from Drug Substance, Drug Product to Fill and Pack), Recipes, Business Partners (Vendors, Customers).
In order to get prepared for a SAP S/4HANA Transformation journey CDMOs can use Tenthpin’s Discover Approach to thoroughly prepare the implementation project. The main element is the Tenthpin Best Practice CDMO Enterprise Process Model which serves as a reference. As a result of this Discover phase a detailed scope, target application architecture, business case and implementation roadmap.
As a CDMO enterprise you will benefit largely from Tenthpin’s CDMO Model: