Search results for " PAT"
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…ntitious viral agent contamination and to ensure uninterrupted supply of safe biological products to patients in need.
Product safety and quality by design (QbD)
Traditionally, product safety…
Article
Biopharma Advances Demand Specialized Expertise
Lively, PhD, director of biopharmaceutical services, PPD; Scott Lorimer, VP Global Operations, Patheon Biologics; Eugene McNally, PhD, executive director, PPD Consulting; Rekha Patel, global director,…
Article
Continuous Manufacturing: A Changing Processing Paradigm
Konstantinov writes that FDA is in the position to offer incentives to vendors “to develop required continuous unit operations (particularly downstream) and PAT [process analytical technology] instrum…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Risk levels of CQAs are assigned based on severity to patients
b. Process parameters are related to CQAs by unit operation
c. Prior knowledge and scientific knowledge is applied to assign init…
Article
Quality by design for biotechnology products—part 1
Thus, to implement QbD, it is critical to have a fundamental understanding of the functional relationships between patient needs, product quality attributes, analytical capabilities, and the manufactu…