Search results for " continuous"
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
What role is QbD playing in continuous manufacturing programs?
It could be argued that the renewed interest in continuous manufacturing was pushed by QbD implementation, in particular that of Proce…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The purpose of continuous verification is to ensure that through the lifecycle of a method there is a strategy by which assurance can be gained that the measurement data quality remains within the req…
Article
Relationship Building at Top of Mind for Clients
Annual study shows technical expertise is not enough.
Aug 1, 2014
By: Eric Langer
BioPharm International
Volume 27, Issue 8, pp. 12-14
Contract manufacturing organizations (CMOs) shou…
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
From the larger perspective, Masser points out that the conversion of the traditional batch manufacturing processes currently used for downstream manufacturing to more continuous approaches requires t…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
This limitation frequently is one of the primary drivers of establishing the continuous process verification (CPV) program in Stage 3 to monitor the future impact from this raw material variation. For…
Article
Biotechnology Innovation and Growth in Israel
Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.
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Article
Bracing for a Future Wave of Advanced Therapies
With the help of recent investor interest, progression of advanced therapy medicinal products (ATMPs) in the clinical space continues to move forward. Buoyed by the regulatory approval of sever…
Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
By Jill Wechsler
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Drug development and regulati…
Article
Cytiva Introduces the Xcellerex Automated Perfusion System
“Along with our end-to-end flexible manufacturing solutions, automation technology, and trusted expertise, we have introduced Xcellerex APS to support the industry’s journey to integrated continuous m…
Article
Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
I am thinking, for example, of explaining significant changes in the chromatograms of scale down models, or of converting batch processes to continuous multi-column processes entirely in silico. In ma…