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Manufacturers Struggle with Breakthrough Drug Development
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs” that offer exceptional promise in treating patients with serious medical needs. Such designa…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
A…
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Prescribing Caution for Biosimilars
They are also a necessary measure to ensure that patients and their physicians remain in control of their medical treatment decision-making as the market for complex biologics evolves over the next se…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
…arching, and adherence to strict quality standards is essential to ensure consistency and safety for patients.
Scaling considerations
Scaling itself does not necessarily increase the risk of lo…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Sponsors looked to deliver experimental treatments directly to patients and to record symptoms and treatment effects at home. Interest rose in innovative clinical research methods, such as master prot…
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Gene Therapies Push Viral Vector Production
Gene Therapies Push Viral Vector Production
Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable?
By Feliza Miraso…
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FDA Framework Spurs Advanced Therapies
“Further consideration will need to be given to the production of autologous products and personalized medicines and how to accommodate those patients for whom an individually manufactured treatment i…
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Transformative Medicines Challenge FDA and Manufacturers
Recent months have witnessed the emergence of truly breakthrough therapies, led by Novartis’ CAR-T therapy Kymriah (tisagenlecleucel) for patients with relapsed acute lymphoblastic leukemia; this appr…
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mAbs to Watch in 2016
Most of the emerging large-molecule drugs in the asthma pipeline are interleukin inhibitors targeting inflammatory pathways and are indicated for patients who have a reduced sensitivity to corticoster…
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Modern Manufacturing Systems Key to FDA Quality Initiative
While CDER does not plan to publish specific company ratings at this time, a manufacturer could choose to promote high quality reports to payers, patients, and health professionals.
Biopharma comp…