Search results for " conference"
Article
Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing.
By Cynthia A. Challener
Vaccine development is a complicated process that can take many yea…
Article
Tackling Analytical Method Development for ADCs
“Testing requirements will still be identity, purity, impurities, activity, concentration, and stability as outlined in the International Conference on Harmonization’s ICH Q5C (1) and ICH Q6B (2) biol…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Mhatre, “LC-ESI/MS and MALDI-MS for Monitoring of Glycoform-Related Clearance of a Complex Glycoprotein in Cynomolgus Monkeys,” presentation at the 58th ASMS Conference on Mass Spectrometry (Salt Lake…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
Nonetheless, the pharmaceutical industry has been internally adopting the QbD concepts laid down in the guidelines of the International Conference on Harmonization (ICH) covering pharmaceutical develo…
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
International Conference on Harmonization. Q6B, Specifications: test procedures and acceptance criteria for biotechnological/biological products. Geneva, Switzerland; 1999.
4. US Food and Drug Adm…
Article
Regulatory Challenges in the QbD Paradigm
…" and "International Compliance" were some of the key sessions at the 2011 PDA/ FDA Joint Regulatory Conference. Implementation of quality by design (QbD) in this environment has further contributed …
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
They’ve been making presentations throughout last year at various industry conferences and they’ve published several articles over the last year that talked about their approach to the development of …
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Waterfield, presentation at BioProcess International Conference & Exhibition (Providence, RI, 2010)
45. E. Shacter, presentation at American Chemical Society Conference (San Franscisco, 2010).
…
Article
Sterilization Trends for Single-Use Consumables
Many of the agencies have sent representatives to industry conferences and workshops on X-ray sterilization and hence awareness is expected to be increasing. FDA representatives also plan to visit som…
Webcast
Swiss Biotech Day
The Swiss Biotech Day is a premier biotechnology conference in Europe, attracting professionals from the global life sciences community. In 2024, it will once again provide a platform for networking…