Cell & Gene - May 9, 2025

Ongoing Part-time Support in Artwork and Serialization for (Start-up) Biotech Companies

By Lujain Mousa

The effective and efficient management of artwork and (operational) serialization processes is essential in any biopharma company, including (start-up) biotechs. These specialized activities rarely require full-time resources, which is a challenge for especially start-up companies. AIM supports multiple clients with flexible and long-term arrangements providing expert guidance on artwork compliance, implementation of serialization processes meeting global standards, and advisory on evolving requirements and process optimization. This model gives clients access to specialized expertise precisely when needed without the overhead of full-time positions. Employees can focus on other core activities while ensuring compliance in these technical but essential areas, providing continuity throughout their growth journey.

Cell & Gene - May 29, 2024

Allogeneic Cell Therapy European Supply Chain

By kingdesign

A US-based clinical-stage company was preparing to launch its first allogeneic cell therapy in Europe. It had no European supply chain capabilities, so it needed support to design and prepare the commercial supply chain. Our team helped design and set-up the supply chain, along with just-in-time packaging, QP release, and distribution processes. We also established the chain of identity and related labeling processes, selected and contracted with a European CPO and 3PL partner, helped ensure inspection readiness, supported the company’s successful EMA submission preparation, and provided ongoing support during the start-up phases.