Search results for " analytics" in Articles / App Notes
Article
Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
Article
Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…
Article
Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve.
The European Union is strengthening its pioneering role in the regulati…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
The Future of Biopharma
TREND ANALYTICS
To gain perspectives on these and other trends, BioPlan Associates asked the 425 global subject matter experts and senior participants on its Biotechnology Industry Council to eval…
Article
Evaluating the Use of Continuous Chromatography
Continuous processes continue to advance in bioprocessing. In downstream processing, continuous chromatography is gaining traction in the purification of protein therapeutics. As the biopharma…
Article
Alternative solutions to separate AAV full and empty capsids using anion exchange
Adeno-associated virus (AAV) is the main vector for gene therapy and there is need for scalable, cost-efficient, and robust chromatography-based purification. Key for a successful process are …
Article
How to develop a scalable rAAV process
Adeno-associated virus (AAV) is the most common vector for gene therapy, yet there’s much room to improve production, purification, and analytics. Here we present the latest updates to our wor…