Case Studies

Recent Projects

Develop
Business Process
Blueprint

global standardization

Lonza

Cell & Gene
Viral Vector
mRNA
Exosomes

Location

Geleen, The Netherlands
Lexington, USA
Houston, USA

Start Date

August 2019

Completed Date

August 2022

About

Main ask was to develop, design, and implement a standard Business Processes and Architecture for the end-to-end supply chain processes within the Cell-and-Gene production sites. Main element is to establish a supply chain governance including master data management, the definition of BOMs and recipes, sourcing lists, etc. It covers the following processes:
  1. SAP Material Traceability (P2M)
  2. SAP Outbound Traceability (O2C)
  3. SAP Goods receipt (P2P)
  4. SAP Material creation and classification (P2P, P2M)
  5. SAP QC repository testing (P2M)
  6. Hazardous Goods Classification (P2P)
  7. Receiving of Donor material and Apheresis (P2P)
  8. Project Planning - Master project Plan (P2M)

Challenges

As a Contract Development and Manufacturing Organization (CDMO) serving numerous clients,  business units, and varied operational approaches, the project faced a significant lack of standardization across the  organization.

icon-alt

Bottom up design, top down deployment

With numerous sites, customers, and processes, standardization can quickly escalate into scope creep and a never-ending process.

To mitigate this, the project developed a blueprint for at first a smaller pilot site, incorporating all complexities and build a bottom-up solution. After this successful implementation was achieved at the pilot site, the project deployed the blueprint to all Cell and Gene sites, ensuring a top-down approach to standardization.

icon-alt

SAP as GMP system

Lonza's Enterprise Resource Planning system SAP, is considered a Good Manufacturing Practice (GMP)-relevant system.

To streamline implementation and validation, the global IT team did validate requirements at a global scale, leveraging a pre-configured system.

However at the business unit or site level, the specific processes require to combine common elements into a site-specific architecture, which thenm should be treated as a customized system.

To comply with GAMP5 guidelines, the project had  to conduct extensive computer system validation (CSV) testing tailored to the specific process build.

Result

The Business Process Architecture is outlined in a comprehensive Blueprint document and a series of Standard Operating Procedures (SOPs), which serve as the guiding principles for the deployment of Lonza's processes across existing Cell and Gene Therapy sites.

The blueprint is deployed in new acquisitions as well, ensuring consistency and efficiency throughout the organization.

The process is being applied on different production sites with over 1000 users.

Solutions

Mutatis Mutandis assists companies to design and implement a supply chain strategy. This is done with attention to the dynamics that companies characterizes. We strive towards a structural embedding of the changes within the organization. We want that our clients do the right things because they want it by themselves and surely understands how it works.
  • qxio-checkmark-circledDedicated subject matter expertise
  • qxio-checkmark-circledMore than 30+ years of experience
  • qxio-checkmark-circledMulti-cultural and International oriented
  • qxio-checkmark-circledCreative Critical Out-of-the-box thinking

Feel free to contact me

qxio-social-whatsapp-outline

( + 31 ) 6 100 34 200

There for you on WhatsApp