Search results for " quality"
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Immunogenicity and efficacy
High levels of aggregates can reduce therapeutic efficacy of a biologic, or impair product quality or stability. This could increase the risk of an immunogenic response…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Third is increased focus on relating the quality attributes of a biotech product to its clinical safety and efficacy. Fourth is the extension of the QbD concepts from the traditional process developme…
Article
Relationship Building at Top of Mind for Clients
…mall scale and large scale when a CMO has been engaged, and clients will always demand expertise and quality.
But the trends in the data suggest that as the CMO market becomes more competitive and…
Article
EMA Invites Comments on New Guidance for Vaccine Development
It follows the publication of a module on the quality requirements.
The new modular guideline is intended to cover and update in one single, consolidated document the existing guidance on regulato…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
Process development was the only area where over half of respondents plan to offshore in the next five years (although with increased emphasis on QbD and related quality issues, one would presume less…
Article
Navigating Emerging Markets: Middle East and North Africa
As the standard of living in the region generally improves, healthcare providers will face rising expectations for more and better quality services. These expectations, together with population growth…
Article
Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
That topic was discussed more in detail by Christophe Segard and Catherine de Coupade from LFB in the Manufacturing and Quality sessions.
On the topic of Pathogen Safety, Sally Bayliss from Paul…
Article
Flexibility in Biopharmaceutical Manufacturing
By: Simon Chalk
BioPharm International
There is a high degree of consensus in the biomanufacturing industry that product quality, customer service, and cost efficiency are fundamentals for suc…
Article
The Future of Biopharma
CONCLUSION
The key trends in this industry are being driven by the need for new efficiencies, greater quality, and cost reductions in manufacturing processes. To remain competitive, especially as …
Article
Selected courses from cell culture and downstream process development to scale-up and manufacturing
Examples of available free of charge eLearning courses:
What is quality by design (QbD)?
Principles of cell line development
Bioreactor scaling
Filtration in bioprocessin…