Search results for " development" in Articles / App Notes
Article
Continuous Processing for the Production of Biopharmaceuticals
With the growing demand for biosimilars and an ever-increasing pressure for reduction in manufacturing costs, the biotech industry seems to exhibit a flourishing interest in the development of continu…
Article
Framing Biopharma Success in 2016
Oversized, inefficient research, development, and manufacturing engines were downsized, or transferred to outsourcing providers.
In 2015, FDA’s Center for Drug Evaluation and Research (CDER) appro…
Article
Biomanufacturing Outsourcing Globalization Continues
A solid majority of biologics developers indicated in the 2015 study that they will not offshore any of their process development for biomanufacturing over that period, a result that is consistent wit…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
At this point in the process development stage, the design space has been determined. It may not be rectangular (if there are higher-order terms in the models) and may not include the entire proven ac…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
Similarly, the proportion of respondents reporting having outsourced upstream process development has more than doubled since 2010, from 17.1% to 43.2%. Comparable rates of growth are also seen with o…
Article
Early Communication with Regulators is Essential for SMEs
Europe’s regulatory agencies have been stepping up their support for small- and medium-sized enterprises (SMEs), including micro companies, in an effort to stimulate more development of innovative med…
Article
Sign-up to join Chromatography Virtual Summit 2022
Virtual event 15–17 November 2022
Join the Cytiva chromatography summit online to learn how you can make your chromatography process development smarter and faster!
Join presentations …
Article
Lessons Learned from the Biopharma Industry's Response to the COVID-19 Pandemic
Topic covered include:
1:38 – The typical time frame for process design and process qualification for a biopharmaceutical development program
2:10 – The driving forces for the rapid scal…
Article
Patenting Prospects for Cell-Based Therapies
By Kevin Noonan
Treatment using cell-based therapies is a rapidly advancing area of clinical research and development. It is also one that involves significant investment and, therefore, can b…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
However, development and optimization of a process chromatography step presents a major challenge due to the large number of process parameters that can affect the performance of the step. For example…