Search results for " biotechnology" in Articles / App Notes
Article
Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
Article
A Second Modular Biopharma Facility Opens: KUBio in Hangzhou
To bring advanced biosimilar products to the Chinese market quickly, Pfizer’s Global Biotechnology Center will make use of Cytiva’s KUBio advanced modular manufacturing solution. KUBio modules …
Article
Microbiological Testing: Time is of the Essence
International Council for Harmonisation, Q5A (R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (September 1999).
2. FDA, “FDA issues final rul…
Article
Lessons Learned Accelerate Vaccine Development
…cal company) as the prime and a modified vaccinia Ankara (MVA) vector (MVA-BN technology from Danish biotechnology company Bavarian Nordic) as the boost.
The first GMP batch of its Ebola vaccine …
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Cell detachment is probably one of the most relevant processes hindering a faster development for cell-based biotechnology. In this article, the authors focus on different strategies available for ani…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis.
By Michiel E. Ultee, PhD, Dr. Richard Easton
This article reviews the implications of cell-culture co…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
An assessment of mycoplasma contamination in the National Center for Biotechnology Information Sequence Read Archive conservatively found that 11% of projects were contaminated (19). The authors estim…
Article
A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
Process Development Forum speaks with Professor Alois Jungbauer, Department of Biotechnology, BOKU, Vienna, about Hydrophobic Interaction Chromatography (HIC).
What is your view of HIC in the bi…
Article
Breakthrough Drugs Raise Development and Production Challenges
Kay Holcombe, senior vice-president of the Biotechnology Industry Organization, urged close examination of ways to prevent approval delays due to difficulties in making a drug according to specificati…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
PDA, Technical Report 54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations (PDA, 2012).
5. PDA, Technical Report 68, Risk-Based Approach for …