Search results for " quality" in Articles / App Notes
Article
Understanding Validation and Technical Transfer, Part I
Therefore, the manufacturing and purification processes become critically important in ensuring the “sameness,” quality, efficacy, and safety of these products.
Process validation is documented…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Product safety and quality by design (QbD)
Traditionally, product safety has relied on the incorporation of three key measures into the manufacturing process: selection, testing, and viral clearan…
Article
Best Practices for Selecting a Top-Quality Cell Line
Challener
Cell lines determine the performance of bioprocesses and the quality of the biologic drug substances they produce. As such, selection of the optimum cell line for each specifi…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Jul 01, 2015
By Susan Haigney
BioPharm International
Volume 28, Issue 7, pg 34–36
BioPharm International spoke with Stephan Krause, director of quality assurance, Laura Jeannel, asso…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The most common definition of regulatory science is a discipline that creates new tools, standards, and approaches for use in assessing the safety, effectiveness, quality, and performance of products.…
Article
Assessing Manufacturing Process Robustness
ICH guidelines Q8–Q12 (1–5) and those in development such as ICH Q14 (6) have applied science, risk management, and quality systems to enhance process and product quality.
In 2011, …
Article
Supply Chain Challenges for Single-Use Systems
The large number of raw materials makes forecasting demand more difficult and requires robust materials management, supplier quality management, quality control, and business continuity planning to en…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
During development and quality control, a range of analytical technologies are used to characterize biotherapeutic drugs, including methods to analyze their structural integrity and activity. Target/l…
Article
Addressing the Complex Nature of Downstream Processing with QbD
The International Council for Harmonization (ICH) defines QbD as a systematic approach that incorporates prior knowledge, results of studies using design of experiments (DoE), use of quality risk mana…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Such advances, though, require further clarification of regulatory policies governing gene therapy production and quality assurance.
FDA is considering at least three CAR-T applications, and mo…