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Growth and Advancements in Fill/Finish
Employing novel technologies and more patient-centric approaches
Delving into Biopharmaceutical Development and Manufacturing
Quality Considerations in Changing Excipient Providers
February 15, 2023
Growth in outsourcing has been the result of COVID-19 projects taking precedence, which has pushed some contract manufacturing to second-tier CDMOs.
In the coming year, pharmaceutical innovation will be fueled by key trends throughout the quality sector.
The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.
Although new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.
The COVID-19 pandemic helped to showcase RNA molecules and their therapeutic potential. There were also lessons learned in terms of drug delivery, manufacturing, logistics, and storage.
February 13, 2023
After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.
Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy.
The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.
The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.
February 09, 2023
Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.