Search results for " process" in Articles / App Notes
Article
Biopharma in 2015: A Year for Approvals and Innovations
The EU was the first geographic market to develop the process of authorization of biosimilars, setting an example for many other developing markets to follow suit. As of 2015, the EU approved 19 biosi…
Article
Tackling Analytical Method Development for ADCs
…guidelines; however, the testing must cover both functional and physiochemical properties, including process control methods and release and stability-indicating assays for both the large and small m…
Article
Applying GMPs to the BioPharma Supply Chain
Change notification and early warning
Suppliers at all points in the inbound supply chain must have a proper process for notifying their customers and hence, end users, of changes to raw material …
Article
2014 Manufacturing Trends and Outlook
…ems, identified challenges for different therapies, and suggested technology enhancements to improve process efficiencies (1).
Survey respondents represented research, development, formulation…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Among these initiatives are the Pharmaceutical cGMPs for the 21st Century, process analytical technology (PAT), quality by design (QbD), and harmonization of international standards and guidelines.
…
Article
FDA Seeks Metrics to Define Drug Quality
Most obvious are reports of company recalls, poor inspection outcomes, and adverse events that are visible to FDA and can indicate broader deficiencies in manufacturing process and control strategy.
…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
Part of this initiative identifies specific standards, methods, and questions for drug reviewers to use in their review process. The overall effort builds upon the agency's Critical Path Initiative, l…
Article
HTPD 2023 conference is coming up. What will be discussed and what happened last time?
As on previous conferences, HTPD 2023 will, with the support from industry leaders, cover a broad range of topics related to smarter and more efficient process development. Both the evolution of matu…
Article
Sign-up to join Chromatography Virtual Summit 2022
Virtual event 15–17 November 2022
Join the Cytiva chromatography summit online to learn how you can make your chromatography process development smarter and faster!
Join presentations …
Article
Scalable Viral Vector Manufacturing
The manufacturing processes and technologies are critical to enable cost-efficient and scalable production of safe and efficacious clinical-grade virus products. This week, Process Development Forum s…