Search results for " design"
Article
CDMOs Driving Emerging Bio/Pharma Success
• Regulatory pathways such as the breakthrough therapy designation enable smaller clinical programs and faster approval times, while the 503(b)2 pathway for new formulations of older products may mea…
Article
Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
By Jill Wechsler
…
Article
Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this stu…
Article
Preclinical Evaluation of Product Related Impurities and Variants
A full factorial design of experiments (DoE) was performed to evaluate the effect of refold pH and cystine/DTT (15). In this study, levels of monomer, oxidized, and reduced GCSF were taken as product …
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
All templated processes start with a single purification process, but there are things you can do to increase the likelihood that it will translate well into a platform such as designing around the mo…
Article
3rd BioProcessing Asia Preview: Q&A with John Curling
…;Plasma product biotechnology: the changing environment
• Theory and practice of facility design, process economics and lean manufacture
Unlike many other conferences. BPA invites the submiss…
Article
Process Development: What May Lie Ahead in 2018?
Single-use bioreactors, for instance, are increasingly available from a host of vendors, and suppliers of such technology have made “significant advances in film technologies, bioreactor designs, stir…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
These centers are designed to analyze data and provide insights for production forecasts, identify planning and risk metrics, and predict trends and areas of improvement across all of the company’s su…
Poster
Rapid Process Development of a CIEX Step for a Biosimilar
By providing the process development support, aggressive timelines could be addressed, which resulted in an accelerated progression of bioprocess design to reduce timelines.
The aim was to select t…
Poster
A Next Generation Protein A Chromatography Resin for Improved Productivity and Bioburden Control
This poster presents a newly designed, high-capacity Protein A resin, MabSelect™ PrismA, which offers alkali stability on par with ion exchange and hydrophobic interaction chromatography resins, enabl…