Search results for " specification"
Article
Modern Manufacturing Key to More Effective Vaccines
…y when combating epidemics, such as accepting supportive CMC data from platform-related products and specifications based on related products. Test vaccines also may be used prior to obtaining real-t…
Article
Preclinical Evaluation of Product Related Impurities and Variants
As a result, the commonly followed approach involves assignment of a specification for the variants based on statistical analysis of the levels seen during commercial manufacturing. Thereafter, monito…
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
An interview with Aaron Noyes, Head of Downstream Processing at Codiak BioSciences
Some therapeutic targets have long frustrated drug developers hoping to crack the code of mitigating un…
Article
3rd BioProcessing Asia Preview: Q&A with John Curling
The 3rd BioProcessing Asia conference will take place November 12-15, 2018 on Langkawi, Malaysia. This week, Bioprocess Development Forum talks with John Curling, Conference Chair, about the upcomin…
Article
Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…
Article
QbD Improves Cell-Culture Process Control
The goal of MPC is to meet various CQA specifications by manipulating process inputs while also taking into consideration process constraints.
Reference
1. W. Sommeregger et. al, “Quality by C…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…
Article
Concentration and Buffer Exchange Using the Automated, Single-Use ÄKTA™ readyflux System
This work describes the capabilities of ÄKTA readyflux when used in ultrafiltration/diafiltration (UF/DF) applications. The process was conducted in an automated manner based on methods created …
Poster
Rapid Process Development of a CIEX Step for a Biosimilar
When establishing purification processes for a biosimilar molecule it is important to develop steps that are scalable, selective, and cost-effective.
A cation exchange (CIEX) chromatographic ste…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Participants explored strategies for analytical method development, assay validation, product characterization, specification setting, and for establishing relevant manufacturing controls for these hi…