Search results for " drug" in Articles / App Notes
Article
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…
Article
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…
Article
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 …
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
Managing Residual Impurities During Downstream Processing
Challener
Manufacture of protein and other biologic drug substances via cell culture or fermentation occurs with the natural, simultaneous production of other unwanted materials, particularly host-…
Article
Critical Quality Attributes Challenge Biologics Development
CQAs are generally associated with the drug substance, excipients, intermediates (in-process materials), and drug product” (1). While CQAs of small-molecule drugs can affect the purity, strength, drug…