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Ensuring Business Continuity in Uncertain Times: Understanding Five Risk Categories that Can Lead to Better Mitigation Strategies
In a time where businesses are being forced to come up with contingency plans for pandemics, one industry that is particularly vulnerable is the pharmaceuticals sector. The supply chains that…
Small Molecule Orphan Drugs: Balancing Financial Incentives And Complex Challenges
Author: Kevin Kane, Global SME, Thermo Fisher Scientific Abstract:The orphan drug industry focuses on developing life-changing and potentially life-saving treatments for patients living with rare diseases. Previously, the needs of…
Interchangeability Between Hard Gelatin and Hard Hypromellose Capsules Without Gelling Agent
PurposeHard gelatin capsules have long been used in a substantial proportion of oral dosage forms. However, they have some shortcomings. Concerns include the potential to become cross-linked, resulting in problems…
Applications of Liquid-Filled Capsules for Challenging APIs in Pharmaceutical Manufacturing
Liquid-filled capsules offer significant benefits for active pharmaceutical ingredients (APIs) presenting formulation or manufacturing challenges. Their use is beneficial throughout the different phases of drug development, from preclinical to commercialization.…
N-nitrosamines in Drug Products: Overview, Challenges and Lessons Learned from an API Manufacturer’s Perspective
By Karina Boszko, Head of API Regulatory Affairs and Customer Technical Support Department, Polpharma API Nitrosamines—how has it all started?In July 2018, the pharmaceutical industry was surprised by the unexpected…