Search results for " conference" in Articles / App Notes
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Mallya, “Validation of Analytical Methods,” presentation at the Stability Conference of International Pharmaceutical Association of Canada (New Brunswick, NJ, May 2013).
22. N. Afonina, L. Bhattac…
Article
Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…
Article
Biopharma in 2015: A Year for Approvals and Innovations
Continuous processing escalated in 2015 and was discussed at almost every bioprocess conference or event. This trend was apparent on PDF, where articles on continuous downstream processing generated a…
Article
GMP Challenges for Advanced Therapy Medicinal Products
The meeting also acknowledged that the term “GMP grade” meant different things to different groups, according to an EDQM report on the conference (5).
Adapting GMP implementation based on risk
S…
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Implications of Cell Culture Conditions on Protein Glycosylation
International Conference on Harmonisation (ICH) Quality Guidelines Q6B describe the type of analysis that should be performed in relation to these structures to understand the quantities of the differ…
Article
Selecting the Right Viral Clearance Technology
Recently, however, there have been big improvements in available data with many more articles in peer-reviewed journals and an increase in published conference proceedings. These data have helped sign…
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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
Breakthrough Drugs Raise Development and Production Challenges
…armaceutical Quality (OPQ), at the DIA workshop and again at the ISPE/FDA/PQRI Quality Manufacturing Conference in June 2015. Matecka noted that CDER will schedule CMC-specific meetings during develo…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…igation in biopharmaceutical manufacturing?
AstraZeneca: We are required to follow International Conference on Harmonization (ICH) Q9 for QRM and ICH Q10 (1, 2) for the risk oversight by senior q…
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 …