Search results for "scale-up" in Articles / App Notes
Article
Continued Process Verification for Biopharma Manufacturing
QbD recognizes that scale-up and industrial-scale commercial manufacturing experience provide knowledge about the process and the suitability of raw materials used. FDA’s January 2011 process validati…
Article
Q&As with Industry Leaders
Putrich, BioPharm International
John Scibetta, Advanced Chromatography Specialist, Cytiva
Q&A: Oligonucleotide Synthesis in Process Development and Scale-Up
Megan Manzano, BioPh…
Article
Manufacturers Struggle with Breakthrough Drug Development
27, 2014) that breakthrough drug development requires information on critical quality attributes, potential scale-up strategies, comparability exercises, and validation plans. FDA will want to know ho…
Article
Predicting Progress in Protein Aggregation
…n much earlier in the drug development process, which helps avoid potential problems throughout the scale-up, manufacturing, and formulation stages,” asserts Zurdo.
New analytical tools for agg…
Article
Best Practices in Adopting Single-Use Systems
Neglecting these considerations can result in costly delays and an uncertain pathway to commercial scale-up.
Materials
Materials of construction constitute a principal factor when sp…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Included in the justification is the expected relationship with CQAs and how the parameter may be influenced during scale-up. Fixed parameters are set to non-critical as they do not impact process var…
Article
Evolution of the Monoclonal Antibody Purification Platform
The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.
Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline…
Article
Regulatory Challenges in the QbD Paradigm
When scale-up of the process is part of a site-transfer eCP, comparability process and criteria should be well defined, along with control parameters and strategy to ensure product quality and safety.…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
As more companies are gaining experience with continuous manufacturing, benefits are emerging, including cases of reduced manufacturing scale-up issues, reduced material usage in development, and flex…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Subsequent purification is accomplished by classical column chromatography techniques with size-exclusion chromatography cited most frequently, which is not a desired step for scale-up (41). The chall…