Search results for " biotechnology" in Articles / App Notes
Article
Putting Viral Clearance Capabilities to the Test
ICH, Q5A (R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, Step 4 version (ICH, 1999).
Article
Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
Article
3rd BioProcessing Asia Preview: Q&A with John Curling
…revention rather than cure: vaccine development and manufacturing trends
• Plasma product biotechnology: the changing environment
• Theory and practice of facility design, process economics a…
Article
QbD Improves Cell-Culture Process Control
al, “Quality by Control: Towards Model Predictive Control of Mammalian Cell Culture Bioprocesses [2],” Biotechnology Journal online, DOI: 10.1002/biot.201600546, March 31, 2017.
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Voss, Cleaning and Cleaning Validation: A Biotechnology Perspective pp 1-39 (PDA, Bethesda, MD, 1996).
10. ASME, Bioprocessing Equipment (BPE) p. 52 (2012).
11. G. Verghese and N. Kaiser, …
Article
Modeling and Miniaturization: Key Topics at Successful HTPD Conference
The first session also contained one appreciated talk from outside the core field, with Luis Cascão-Pereira from DuPont talking about white biotechnology and process development of enzymes used for wa…
Article
Patenting Prospects for Cell-Based Therapies
Kevin Noonan is partner at McDonnell Boehnen Hulbert & Berghoff LLP and chair of the firm’s biotechnology and pharmaceuticals practice group.
References
1. E. Buz…
Article
Contract Manufacturing Through the Years
A second factor was the explosion of early stage bio/pharma companies, thanks to the maturity of biotechnology and the availability of external funding. Emerging bio/pharma companies rode the coattail…
Article
Witnessing Major Growth in Next-Generation Antibodies
More growth expected
Most large pharmaceutical and biotechnology companies have recognized the importance of next-generation antibody therapies and have multiple products under development, whethe…
Article
The Tide Stays High
Equity markets’ appetite for public offerings from emerging bio/pharmaceutical companies had significantly diminished: valuations of emerging bio/pharma companies, as measured by the NASDAQ Biotechnol…