Search results for " process"
Article
Concentration and Buffer Exchange Using the Automated, Single-Use ÄKTA™ readyflux System
The process was conducted in an automated manner based on methods created using phases predefined in the UNICORN™ system control software. Concentration of 5 g/L bovine serum albumin (BSA) was perfor…
Article
Handbook: Design of Experiments in Protein Production and Purification
Based on the obtained data, a mathematical model of the studied process (e.g., a protein puri cation protocol or a chromatography step) is created. The model can be used to understand the in uence of …
Article
Platform Technologies Improve Protein Expression
In addition to exploring novel production methods such as continuous processes and disposable production technology, manufacturers also heavily invest in platform technologies for protein expression t…
Article
N-Glycan Analysis of Biotherapeutic Proteins
…king the characterization of N-glycan structures an essential part of the biotherapeutic development process. The complex, branched structure of N-glycans present a unique analytical challenge. A var…
Poster
Adenovirus production in a single-use stirring tank bioreactor system
Anchorage-dependent cells cultured in roller bottles or cell factories are commonly used in these processes. However, scale-up using these techniques is complicated and limited by the surface availabl…
Article
Drug Quality Key to Innovation and Access
As 2016 came to a close, FDA officials reported that new drug approvals for the year would fall far short of the near-record set in 2015, raising concerns about current incentives and regulatory proce…
Article
Managing Risk in Raw Material Sourcing
By Agnes Shanley
Choosing excipients and suppliers for pharmaceutical formulations requires a clear understanding of product requirements; material properties; product, process, and material varia…
Article
Real Time Continuous Microbiological Monitoring
…ollecting counts under defined specifications, but rather it helps by showing that the manufacturing process is in a continuous state of control.
A real-time laser-induced fluorescence (LIF) syst…
Article
Innovation vs. Capacity: How CMOs Compete
Characteristics of capacity-driven CMOs include:
• Business strategy based on acquiring and/or maintaining capacity for routine manufacturing processes such as direct compression solid dose presen…
Article
A Q&A with Eric Langer: CMOs Embrace New Technology
… chromatography, single-use probes and sensors, disposable chromatography, instrumentation, upstream process development services, etc. In comparison, biopharmaceutical innovators sought improved ana…