Validating your cold chain to meet and exceed increasingly stringent regulatory expectations in today’s global market is a challenge. With more than 35 international cold chain regulatory compliance guidance documents, global standards are becoming more comprehensive and increasingly complex.
New therapies, accelerating costs, sustainable technologies and emerging markets demand validated cold chain networks that consistently produce low-cost and high-quality outcomes for patients with a minimal variation delivering value to your supply chain.
Build your reputation of reliability with the regulators
Antibody-drug conjugates (ADC) and T-cell therapies are two of the most exciting immunotherapies due to their especially complex cold chains. This complexity presents challenges in the tracking, traceability and storage of the cells a large risk in the treatment process.
New validation approaches based on regulatory responses to previously submitted immunotherapy cold chains will be presented in the webinar.
The goal of cold chain process validation is to create a robust operation that ensures qualified product packaging and validated handling, storage, transportation and distribution operations that are executed according to well-defined, established and proper control and monitoring procedures.
Testing for relevant environmental conditions such as temperature, relative humidity, light, shock and vibration assure product identity, strength, purity, efficacy, quality and safety.
Integrating your stability data on any drug product with your validation strategy will provide protection, especially if your drug product is highly sensitive to the environmental hazards in the transportation network.
Join industry experts Gary Hutchinson and Dan Littlefield from Modality Solutions in this engaging and informative webinar on how to successfully integrate and validate your biopharmaceutical cold chain. Modality Solutions has access to the latest regulatory agency requirements for emerging therapies and will share how to successfully validate your combination medical device, monoclonal antibody or immunotherapy cold chain.
Register for the webinar on Cold Chain Validation Best Practices today by clicking here.