Search results for " development" in Articles / App Notes
Article
Modern Manufacturing Key to More Effective Vaccines
A report from the Pharmaceutical Research and Manufacturers of America (PhRMA) in late 2017 lists 264 vaccines in development, including 137 for infectious diseases and more than 100 for cancer (1). A…
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Transformative Medicines Challenge FDA and Manufacturers
Although the long-term effects of these drugs are unknown, these initial successes have spurred optimism about further development of treatments for both rare and more prevalent serious conditions, pa…
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Managing Residual Impurities During Downstream Processing
USP, in collaboration with its Expert Committee and Panel members, develops public standards that support the development, characterization, and release of therapeutics. USP monographs and associated …
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Ligand-Binding Assays and the Determination of Biosimilarity
For monoclonal antibodies (mAbs), which make up a large portion of the biosimilars currently under development, it is important to remember that the different ends of the molecule are involved in bind…
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Report from the 6th International HTPD Conference
The HTPD conference series started as a joint initiative by Cytiva and Genentech in 2010 at a time when high-throughput process development was in its early days. HTPD was mainly limited to 96-well pl…
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Digitalization: The Route to Biopharma 4.0
It is evident that there is an urgent need to incorporate digital solutions at initial stages of process development, manufacturing, and quality assurance (QA).
Digitalization in pr…
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The Importance of Partnering for Bioanalytical Studies
By Feliza Mirasol
Bioanalytical studies are an important aspect in biologic drug development because data from these studies are needed to define the characteristics of potential new biologic …
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Improving Upstream Predictability
Today, better understanding of cells and how they interact with their environment has enabled improvements in most aspects of upstream processing, from bioreactor design and media development to proce…
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Driving Improved Access to Biosimilars
…companies, and patient groups complained that the lack of final guidance would discourage biosimilar development and leave the public without lower-cost options to name-brand biopharmaceuticals.
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Impurity Testing of Biologic Drug Products
“Aggregates are of particular concern, either in soluble dimer/oligomer form or subvisible particle form,” notes Jay Kang, director of analytical and formulation development at Patheon, part of Thermo…