Ancillary Material File

Reagents and consumables, commonly referred to as ancillary material, are indispensable in realizing a quality manufacturing of cell, tissue, and gene therapy products.

Attention is given to the selection of these components so to as shorten the process development / validation phase by choosing materials that comply with regulatory standards while enabling maintenance of product quality and potency.

An in-house ancillary material master file aids this effort as it represents specific know how on suitability, feasibility, quality, compliance, and safety. This cell-specific list of ancillary material will be derived via in-house experimentation and/or literature search and will be made available to ACTRIS clients.