When ADC handling leaves no room for error
Controlled fluid and cold chain management for biologics in single-use bioprocess containers
Antibody-drug conjugates (ADCs) and other high‑value biologics push fluid handling and cold chain management to their limits. RIsing potency, smaller batch sizes, and highly cytotoxic payloads demand absolute precision, robust containment, and uncompromising operator safety. Manual steps and disconnected solutions introduce risk – from dosing inaccuracies and product loss to exposure and cold chain failures.
Second-guessing your manual filling process? This collection of resources explores how automated, modular, single‑use technologies help manufacturers stay in control. From aseptic filling to protected freezing and transport, the following assets show how to safeguard people, processes, and product, when every drop truly matters.
ADC Manufacturing: Navigating 5 Overlooked Challenges
This practical guide sheds light on often underestimated risks in ADC fluid and cold chain management – including cytotoxic exposure, operator safety, precision filling, freeze‑thaw stress, bioprocess container breakages, and costs. It outlines how closed, automated, and controlled single‑use systems help reduce risk, improve process reliability, and preserve ADC quality across fluid handling and cold chain operations.
DownloadCase Study: Benefits of automated vs. manual ADC filling
An Irish manufacturer implemented the automated filling platform, RoSS.FILL, to prepare ADC intermediates for fill-finish. Automating this process step not only increases operator safety in line with GMP Annex 1, but also results in significant efficiency gains in terms of ROI, time, and personnel.
DownloadRobust storage and shipping: The secondary packaging for every single-use bag
This whitepaper explains how the RoSS® shell, a robust secondary packaging, protects single‑use bags throughout freezing, storage, transport, and thawing. Learn how full immobilization, plate‑based freezing, and vendor‑agnostic design help prevent bag rupture, minimize product loss, and maintain cold chain integrity.
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