Search results for " formulation" in Articles / App Notes
Article
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…
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
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Article
New Therapies Present Scaling Challenges
…ling other aspects of the manufacturing process, such as cell harvesting, downstream processing, and formulation technology, to ensure that the final cell therapy product meets quality standards and …
Article
Biosimilar Quality Requirements
This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosi…
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
Addressing the Complex Nature of Downstream Processing with QbD
We have also developed many high-throughput tools applicable to process and product development within upstream, downstream formulations, and analytical development,” MacDonald says.
The benefits …
Article
Automating the Biomanufacturing Process
“It is crucial to apply the same level of automation and operational philosophy across the entire production, from seed lab to final formulation,” says Lebl.
Ensuring traceability is key, he empha…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
This could be attributed to differences in expression system, culture conditions, purification processes, formulations, or storage conditions of the product and need to be suitably addressed as per th…
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
These current trends include the increased use of isolator/RAB technologies, more high-speed operations, more diversity in formulation and delivery systems, and other innovative approaches—such as one…
Article
CDMOs Driving Emerging Bio/Pharma Success
• Regulatory pathways such as the breakthrough therapy designation enable smaller clinical programs and faster approval times, while the 503(b)2 pathway for new formulations of older products may mea…