Search results for " development" in Articles / App Notes
Article
Rapid Cycling Protein A-Based Fiber Chromatography to Address Emerging Downstream Bottlenecks
Fibro PrismA is a new protein A fiber chromatography format developed to complement traditional resin-based chromatography. The protein A fiber matrix has an open pore structure in which mass transf…
Article
New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
Hybrid Bioprocessing: A Q&A with Andrew Sinclair
Where the productivity of the cell line is equivalent in fed batch and perfusion, then the balance favors fed batch based on efficient media utilization and easier development. Perfusion has potential…
Article
Real Time Continuous Microbiological Monitoring
The results are obtained after enough days of incubation allow the development of colonies to be counted by visual inspection. The results are then expressed as colony forming units (CFU) per unit of …
Article
Perfusion in the 21st Century
Contamination issues have also been significantly reduced with the development of aseptic connections.
Cell separation devices have also become more efficient, allowing for very high cell densitie…
Article
Design and Qualification of Single-Use Systems
According to European Union GMP Annex 15, Section 3, “Qualification activities should consider all stages from initial development of the user requirements specification (URS) through to the end of us…
Article
A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Participants from academia and industry meet and discuss the latest developments in an environment away from the daily routines, rich in scientific quality and engagement, and free from commercial dis…
Article
A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
It is a good thing with the development of high throughput techniques and Design of Experiments. Otherwise, the multimodal chromatography approach would have been even more challenging. If we know the…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Particle-detection methods
There are various detection technologies that should be used to address protein aggregation needs at various phases of the biopharmaceutical development process; however…