Search results for " regulatory"
Article
Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This art…
Article
Process Economic Simulation for Scalable Production of Adenovirus
This application note discloses the process economic modelling of a modern start-to-finish adenovirus production process. The novel process was compared with a reference process in both stainless-st…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
Optimizing Late-Stage and Commercial Cell-Culture Processes
Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.
By Feliza Mirasol
…
Resource
Annual bioProcessUK Conference
A conference for the manufacturing/biologics community organized by UK BioIndustry Association.
Resource
PREP Symposium
PREP 2019 is the longest running, most recognized international scientific conference and exposition driving the field of Preparative and Process Chromatography, organized by expert scientists and eng…
Article
Utilization of Mechanistic Modeling to Improve Process Development
To follow the QbD paradigm and keep up with shorter timelines, process developers are evaluating different approaches to improve process development workflows and gain a better process understanding…
Article
Gain Efficiency in Process Development
The development of efficient manufacturing processes is a necessity for cost-effective production of biopharmaceuticals. By carefully designing and evaluating your experiments, sufficient informatio…
Article
Establishment of New Modern Plasma Fractionation Facilities in Asia
This week, the Process Development Forum talks to Dr. Neil Goss, an international consultant in biotechnology and plasma fractionation, past director of Research and Development at CSL BioPlasma, Aust…
Article
Get Acquainted with How SPR Technology is Used for Better Protein Characterization
Surface plasmon resonance (SPR) has become a go-to tool for biotherapeutic characterization, and most approved antibody therapeutics have passed through a Biacore SPR system.
Stay up-to-date wit…
Article
Cleaning Protein A Resins with 1 M NaOH
With increasing mAb titers, the impurity level of the cell culture feed increases. If not removed, these impurities can build up on the protein A resin and start to leach into the process material i…