Search results for " conference" in Articles / App Notes
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…
Article
Democratizing GMP Manufacturing for the New Therapeutic Pipeline
PharmTech Europe discusses technology that enables the “democratization” of mRNA manufacturing with Scott Ripley, general manager, Nucleic Acid Therapeutics and Precision Nanosystems, Cytiva, …
Article
Digitalization: The Route to Biopharma 4.0
In 2015 12th International Conference on Fuzzy Systems and Knowledge Discovery (FSKD); Zhangjiajie: IEEE; 2016. DOI: 10.1109/FSKD.2015.7382284
2. Knevelman, C.; Davies, J.; Allen, L.; et al. Hig…
Article
Weighing the Benefits of Single-Use Consumables
While the debate between stainless steel and single-use systems (SUS) will continue to rage for the foreseeable future, most would agree that there is a time and place for either approach. Nat…
Article
PEPTalk Event
Visit us at the PepTalk conference in San Diego. Attend our talk, powerpoint presentations, and panel discussions to learn the latest in protein science.
LEARN MORE >> …