Search results for " drug" in Articles / App Notes
Article
A Q&A With Prof. Alois Jungbauer: The Role of HIC in Biotech
I am also convinced that HIC will be a useful tool for purification of some of the new types of biomolecules, such as antibody drug conjugates (ADC). I am aware that HIC is being considered complex. F…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
As pointed out by the judge ruling on the Neupogen case, giving an innovator drug manufacturer 180 days notice of a biosimilar maker’s intention to proceed to market would unfairly add “an uncondition…
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Viral Clearance Challenges in Bioprocessing
The Parenteral Drug Association Technical Report 47 (2) provides a framework for the preparation and characterization of virus preparations, and individual testing labs have developed their own descri…
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Challenges and Trends in Biopharma Facility Design
In the case of producing a blockbuster drug, a large-scale stainless steel facility might actually be the most economical choice, especially if you have low titers and are starting from high-volume bi…
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A Q&A With Parrish Galliher About Adopting Single-Use Systems
Since 90% of drugs fail during the 7-8 years of clinical testing, and plants are traditionally built 5 years ahead of launch, sometimes an investment is made in a plant for a drug that won’t succeed. …
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FDA Urged to Preserve Biosimilar Naming Conventions
“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe; it has worked in the United States for chemical drugs and currently approved biologics, the…
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Q&As with Industry Leaders
…l, President, Windshire Group, LLC
Regulatory Requirements for Safe and Efficient Biologic Drug Development
Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Complian…
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Biopharma Takes a Nervous Glance Over Its Shoulder
According to the study findings, executives feel that US payers increasingly are not adequately valuing new treatments and are too focused on reducing prescription drug costs. This short-term approach…
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Trends in BioPharma Approvals in 2013
This drug is Herceptin to which a small cytotoxic molecule (DM1) has been conjugated, and like Herceptin, it is approved for the treatment of HER2-positive metastatic breast cancer. As in the case of …
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Early Communication with Regulators is Essential for SMEs
The importance of early dialogue with regulators
Companies are encouraged to contact the agencies as early as possible during the drug-development stage to ensure that their manufacturing proces…