Search results for " supply"
Article
Biosimilars: Making the Switch Comes with Challenges
Remsima, then marketed by Hospira in partnership with its developer Celltrion of Korea, won a national tender to supply it to all Danish hospital pharmacies that were able to switch patients to the pr…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.
By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…
Article
A Q&A With Jeff Carter on Trends in Single-Use Technologies
These members are asking their key single-use suppliers to cascade and implement these needs within their supply chain. Some suppliers have already began to work through the BPOG protocol using a risk…
Article
Framing Biopharma Success in 2016
Industry feedback to the draft guidance reflected concerns about how FDA will use the reported data to guide further regulatory action, what players in the supply chain were responsible for reporting …
Article
KUBio modular biopharm facility built in Germany, assembled in China
Cytiva is supplying a full biopharmaceutical processing solution, known as a KUBio, to JHL Biotech in Wuhan, China. The sixty-two completed modules that make up the factory have completed the journe…
Article
Tools for Continuous Bioprocessing Development
The primary technology hurdle for existing microbioreactors is the development of high-throughput means for continuous fluid addition and harvesting with cell retention capable of supplying up to 100 …
Article
mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
Article
Selecting the Right Viral Clearance Technology
…development because it does not generally have an impact when preparing a small number of batches to supply clinical trials. “When those processes advance to commercial production with regular manufa…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Manufacturing and quality control helps ensure the supply of a consistent quality product to the market. CQAs are determined using the “best” knowledge at a given time; they may later have to be revis…
Article
Selecting a Comprehensive Bioburden Reduction Plan
At large scale, when campaigns are being manufactured to supply the market, it is more likely campaigns of a single-product are being run at a higher run rate in order to achieve operation efficiency.…