CLINICAL SUPPLY MANUFACTURING ARTICLES
A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies
This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities.
CLINICAL SUPPLY MANUFACTURING VIDEOS
Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.
Scale your biologic fill-finish from vials to autoinjectors without disruption. See how integrated device assembly capabilities support every clinical phase through commercialization.
Early planning mitigates risk by avoiding stock outs and study delays, minimizing waste with optimized inventory, and forecasting demand to facilitate robust supply planning.
Industry experts share insights to help you mitigate supply chain risk and accelerate access to novel cell and gene therapies.
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While cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.
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Advanced cGMP facilities deliver control, expertise, and reliable processes that protect quality and support smooth progress to market. Strong partnerships help reduce risk in complex programs.
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Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.
