Search results for "biopharmaceutical"
Article
Quality Systems Key to Lifecycle Drug Management
Jun 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 6
The submission and review of manufacturing supplements is costly and time consuming for biopharmaceutical comp…
Article
A Bright Future for the Plasma Fractionation Industry
…as China and India, were presented by Ranjeet Ajmani from PlasmaGen and Jeff Davies from Centre for Biopharmaceutical Excellence, Australia. Ajmani explained that the rapid economic growth in several…
Article
Continuous Manufacturing: A Changing Processing Paradigm
…s Andrew Sinclair, president and founder of Biopharm Services, a technology company that serves the biopharmaceutical manufacturing business. “About five years ago, as the industry matured, the manuf…
Article
Optimizing Resin Performance with Disposable Chromatography Solutions
Market Trends
BioPharm: How is the market reacting to disposable chromatography solutions? Do you see growth? In what areas?
Royce and Lundström (Cytiva): The highly regulated biopharmaceutica…
Article
DoE Provides Benefits, but Preparation Is Necessary
An added benefit of this efficiency, Yang notes, is the reduced quantity of material needed for formulation development, which can be important early in the development of a biopharmaceutical product …
Article
Single-Domain Antibodies for Brain Targeting
With 25 mAb products on the market and more than 100 undergoing clinical trials (1-3), it is evident that engineered antibodies have come of age as biopharmaceuticals (4).
Intact antibodies (immun…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
…by EMA, included real-time release testing (RTRT), application of QbD to continuous manufacture and biopharmaceutical production, dealing with post-approval changes to QbD processes, and the need for…
Article
Trends in BioPharma Approvals in 2013
A total of 16 approvals were recorded in Europe, while only six biopharmaceuticals came on the market in the US in that same period. This trend can partly be explained by Europe playing catch up in th…
Article
Q&A with Industry Leaders: Rita Peters
With additional product lines through acquisition or innovation, many suppliers emphasized capabilities of providing end-to-end technologies, equipment and support to the biopharmaceutical manufacturi…
Article
Best Practices in Adopting Single-Use Systems
The adoption of single-use systems in biopharmaceutical production originated with the desire to minimize cleaning and associated validation. Before long, bioprocessors recognized the value of flexibi…