TotalLab Selected by Leading Global Pharmaceutical Manufacturer to Deliver Custom, Automated ATMP Workflow Solution

TotalLab Selected by Leading Global Pharmaceutical Manufacturer to Deliver Custom, Automated ATMP Workflow Solution

TotalLab is proud to announce it has been trusted by a renowned German-based, global pharmaceutical company (the largest privately held pharmaceutical company in the world) to develop a fully custom, automated software workflow for Advanced Therapy Medicinal Product (ATMP) manufacturing.

Transforming ATMP Manufacturing with Automated and Compliant Solutions

In response to the increasing demands of the cell and gene therapy industry, our client sought to consolidate a complex ATMP workflow - previously fragmented across multiple software platforms - into a single, unified solution. TotalLab’s tailored software will enable:

• Full 21 CFR Part 11 and GMP Compliance: The solution is designed to meet stringent regulatory requirements, ensuring data integrity and security throughout the ATMP manufacturing process.

• Increased Workflow Automation: Key processes are automated, significantly reducing manual intervention and the risk of human error in ATMP production.

• Enhanced Reproducibility: Standardization minimizes inter-operator variability, optimizing product consistency and reliability across batches and sites.

• Vendor-Neutral Analysis: By delivering an equipment-agnostic platform, TotalLab’s solution decreases reliance on specific equipment providers, supporting flexibility and future scalability.

• Global Harmonization: The platform enables worldwide deployment, harmonizing production and quality control across multiple international manufacturing sites.

Supporting Scalable and Compliant ATMP Manufacturing

This innovative project enables our client to transition their ATMP manufacturing into a robust GMP environment, raising the standard for automation and compliance across the industry. By streamlining data management and process automation, TotalLab is helping to accelerate the delivery of advanced therapies to patients worldwide.

As a trusted partner to leading pharmaceutical manufacturers, TotalLab delivers advanced software solutions that support regulatory compliance, process automation, and global harmonization for life sciences organizations.

Join us in shaping the next generation of ATMP manufacturing, with compliant, automated, and vendor-neutral software solutions designed to meet the evolving needs of the global pharmaceutical industry.

For more information on how TotalLab can support your GMP ATMP manufacturing workflows, contact us.