Genetically Modified Cells

MolMed offers top level expertise for providing tailor-made services for Cell & Gene therapy projects, meeting Client’s needs in terms of ensuring the highest clinical and commercial standards for ATMP.

Our services include the tech transfer, development, scale up, automation and validation of RVV/LVV cell transduction processes, as well as DP filling and release. In parallel, MolMed offers the development, qualification and validation of analytical tests, both compendial and product specific. We perform over 100 analytical tests in house for the release of the products.
MolMed can further assist its customers, offering proprietary processes for gene modification of HSC (CD34+) and T-cells.

Technology Transfer

We offer proprietary process for CD34+ and T-cell transduction. In alternative, we can internalize and
further develop Client’s processes for clinical and commercial products.

Process Development and Analytical Methods Development

Our process development unit has performed several tech transfer, development, scale-up, automation
and validation activities for both proprietary and third parties’ transduction platforms.

GMP Manufacturing

We perform CD34+ and T cells transductions, for both autologous and allogeneic products.
Italian Health Authorities approved our two facilities for the production of both clinical and commercial
products.

Quality Control

We perform over 100 in-house tests including safety, identity, potency, purity on IPC and DS/DP, resulting in time and costs saving.
The release path is finalized by our internal QPs.

QA and Regulatory support

MolMed Quality management system is in line with EU ATMP GMP and Food and Drug Administration (FDA) guidelines.
We also offer support for Scientific Advice to national and international bodies, including documentation for Pre-IND, IND, IMPD and trial specific procedures, designation application (e.g. Orphan drug) and Filing for Marketing Authorization (and equivalent).