This article, the first in a two-part series, details the biosimilar development path to identify and evaluate critical quality attributes for both the candidate biosimilar and the reference product, along the regulatory timeline.
While capacity will increase over the next five years, demand for capacity, pandemic aside, will increase at a slightly faster rate, allowing for some short-term loosening of capacity constraints, but after 2024, capacity tightening may occur.
China is demonstrating clear investment interest in participating in global markets for both innovative biologics and biosimilars produced at GMP quality levels.1 These factors are creating a strong market environment for CMO services.
Representatives from the Russian Federation State Institute of Drugs and Good Practices, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their processes for evaluating and escalating inspection findings to determine if regulatory action is needed.
As the pharma industry scrambles to develop one or more viable COVID-19 vaccines, the greatest hurdle to immunizing the world’s population is the manufacture of billions of doses in parallel. In response to this challenge, vaccine developers are signing an unprecedented number of outsourcing agreements with CMOs and other service providers.
Part one of this three-part series on quality agreements discussed identifying key risks in partnering with contract companies and working with vendors. Part two explored the regulations and enforcement activities associated with quality agreements. In this final part, we examine what to include in quality agreements and who should be responsible for the assigned tasks.
Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information.
This is part two of a three-part article on quality agreements. Part one discussed identifying key risks in partnering with contract companies and working with vendors. This second part explores the regulations and enforcement activities that apply to quality agreements.
Representatives from the Russian Federation Ministry of Health, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and the U.S. FDA share their top 10 pharma company inspection findings from FY2019, revealing many similarities and a few differences.