Search results for " drug"
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Design and Qualification of Single-Use Systems
Equipment Design Regulations and Guidance
While drug and vaccine manufacturers are subject to regulatory review and inspection of how equipment is used, that is not the case for the manufacturers …
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Viral safety needs to be designed into the overall drug-development process and QbD approach.
The concept of product “safety by design” (SbD) represents an integrated, holistic approac…
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Biopharma in 2015: A Year for Approvals and Innovations
Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 2014 and 22% in 2013—which confirms the growing importance of b…
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GMP Challenges for Advanced Therapy Medicinal Products
This view is consistent with a growing support in the R&D sector in Europe for a phased approach to the application of GMP standards, as detailed by the Parenteral Drug Association (PDA) in a 2012 tec…
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Finding Opportunities in Brazil
Sixty-three percent considered brand drugs relevant for medicine and would pay a premium for certain ones (5). The researchers said they believed that high-quality patented medicines were a profitable…
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Biopharma Manufacturers Respond to Ebola Crisis
…l treatments and to provide more flexibility for meeting manufacturing standards for potential Ebola drugs. FDA, for example, used its Emergency Use Authorization policy in August 2014 to allow broad…
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Evaluating Design Margin, Edge of Failure and Process
• There is no generalized accurate conversion from Cpk into a total failure rate for a drug product or drug substance as it is currently defined.
PPM as a Recommended Measure of Process Capability…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
"We expect development of biosimilar drugs to continue at a rapid pace," says Senior Vice President, Michael Levesque. "But while in Europe more than a dozen products are now commercialized, in the US…
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The Affordable Care Act's Impact on Innovation in Biopharma
In the pre-healthcare reform environment, drugs and devices were generally priced at a premium based on modest, incremental improvement in features and benefits (i.e., length of drug action). A fundam…
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Moving Biosimilars Forward in a Hesitant Market
For example, with a small-molecule drug, it is simple to replace that drug at the pharmacy level with a generic because their similarity has been demonstrated. However, it is not the same when dealing…