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Learn how regulators define temporary data and how to maintain data integrity. Find out what to look for in a LIMS for 21 CFR Part 11 and Annex 11 compliance.
Selecting container closure components with confidence: A data-driven approach to container closure integrity
Drug products in development require compatible packaging to meet milestones and gain approval. West supports pharmaceutical partners with a data-driven process to give you confidence with closure containment that meets requirements in the modern regulatory landscape.
Nasal Delivery of Spray Dried Biologics: Opportunities & Challenges
Characterisation of Spray Dried Biologics
Spray Drying Biologics: An Alternative to Freeze Drying
Pharmaceutical Spray Drying: Technology and Applications
Novel Cell Lysis Solution: Scaling up viral vector harvest with ease and regulatory compliance