Search results for " biologic" in Articles / App Notes
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
Cell-culture evolution
Current cell-culture processing has been optimized and has resulted in significantly higher cell densities compared to biologics manufacturing in the past. In the early 1990…
Article
Biopharma Seeks Balance
FDA reports that it has considered emerging technologies for biological molecules including controlled ice nucleation for lyophilization processes, predictive modeling for process monitoring and close…
Article
Establishment of New Modern Plasma Fractionation Facilities in Asia
…commercial forum for the exchange of concepts, ideas, and information relating to the manufacture of biological products in the Asian region. The inclusion of a specific plasma fractionation session …
Article
Process Development: What May Lie Ahead in 2018?
While only 22 new drugs were approved in 2016, FDA gave its thumbs up to 46 new drugs in 2017 (of which approximately one-quarter were biologics). The figures for all new drug approvals are in line wi…
Article
QbD Improves Cell-Culture Process Control
By applying advanced sensor systems combined with mathematical modeling techniques, one can gain an enhanced understanding of the processes that produce the biologic product.
In addition, this …
Article
Roadmap Leads to Innovative Biomanufacturing Strategies
Biomanufacturers are uniquely aware of the challenges faced during development and manufacturing of biologics and they are in the best position to communicate their needs to the suppliers and academic…
Article
ADC Development Robust Despite Lackluster Performance
In one Phase III clinical trial, the company is studying Kadcyla in combination with its anti-breast cancer biologic Perjeta (pertuzumab) as an adjuvant treatment for early-stage HER2-positive breast …
Article
Development of Purification for Challenging Fc-Fusion Proteins
Introduction
Improvements have been made in mammalian cell culture to achieve high productivity processes primarily to meet the increasing demand of biological therapies. In response, tit…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
…cation setting, and for establishing relevant manufacturing controls for these highly perishable and biologically complex products.
Experts from biopharma companies and research organizations…
Article
Downstream Processing for Cell-Based Therapies
Unlike the traditional manufacture of monoclonal antibodies (mAbs) and other biologics, the production and processing of cellular material forms the basis of the product for CGTs (1). As such, manufac…