Search results for " guidance"
Article
Impurity Testing of Biologic Drug Products
Other aspects of method validation are more easily derived from the guidance given in ICH Q2 (R1).
Analytical methods
BioPharm: What are the commonly used analytical methods for charac…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
New guidance documents will be part of the framework, which covers therapeutic tissue engineering products, human cell and tissue products, and certain combination products intended to treat serious o…
Article
Modeling Bioreactor Performance
Effective models can, however, provide guidance to minimize the number of required experimental runs and reduce risks. On the other hand, modeling is less appropriate when the model is unable to hold …
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
EC Notices from European Union Institutions, Bodies, Offices and Agencies “Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary med…
Article
Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
Article
Selecting a Comprehensive Bioburden Reduction Plan
FDA guidance documents, PDA TRs, and the peer-reviewed literature all provide descriptions of potential point-sources of contamination. Bioburden may be associated with personnel, incoming raw materia…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
International Conference on Harmonization (ICH) guidance ICH Q9 (1) encourages that a quality risk management approach be considered and that, based on the level of risk, cleaning processes may be sub…
Article
Robust Optimization, Simulation, and Effective Design Space
Even though there are ICH guidance documents such as Q8 and Q11 that define what a design space is, there is still a poor understanding of the meaning and application of a design space.
ICH Q8, Ph…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Mazzo, arguably one of few life-science company CEOs to even articulate the QbD concept, explains that the company has gone a step further, and broadened the International Conference on Harmonization …
Article
What’s In a Name? For Biosimilars, A Lot
This determination may ultimately factor into future FDA policy or guidance documents on biosimilar naming. While FDA and USP work closely on nomenclature policy, “USP naming is not directly implicate…