Search results for " drug"
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Report from India
(Dmitry Rukhlenko/Getty Images)
On July 1, India's new Drug Pricing Control Order (DPCO) 2013 replaced the 1995 version. Under this new regime, the National Pharmaceutical Pricing Pol…
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Advancing QbD in the EU
In addition, EU authorities are becoming more concerned about the increasing number of quality defects in pharmaceutical manufacturing that have been causing a rise in drug scarcities.
ICH GUID…
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Introducing Supor Prime Filters: A Filtration Solution for High-Concentration Therapies
This trend is mainly driven by the demand for subcutaneous drugs that are self-administered by the patient through the skin instead of the vein (IV) at the hospital or clinic. These drugs improve qual…
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Good Manufacturing Practices: Challenges with Compliance
There is less guidance, however, on how to formulate and develop a more complex biological drug product as you reach the finished dosage manufacturing stage.
The amount of complex formulation wo…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Earlier this year, FDA issued a statement revealing that there are already more than 800 active cell-based or directly administered gene therapy investigational new drug applications (INDs) currently …
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Addressing the Complex Nature of Downstream Processing with QbD
Specifications for the drug substance, excipients, and drug product and controls for each manufacturing step are determined through a control strategy. The final elements of QbD are process capability…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Compared to the traditional small-molecule (pharmaceutical) drugs, biotherapeutics are complex and have the ability to bind to more than one target molecule. Biosimilars provide a more affordable trea…
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Nurturing Knowledge from Disparate Data Streams
has been established and test methods validated for a drug substance, there are many human intervention steps involved to get from a request for release to fulfilling that request, explains Andrew And…
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Applying GMPs in Stages of Development
Some of these relationships can be complex, so it is important for every organization involved in the drug development process to be familiar with what the applicable GMPs are and at which stage of th…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
Specifically, Codiak is investigating the delivery of nucleic acids and engineering exosomes that, when combined with a platform production process, can become exosome drug therapeutics that are scala…