Search results for " clinical development" in Articles / App Notes
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…
Article
Can Vaccine Development Be Safely Accelerated?
Can Vaccine Development Be Safely Accelerated?
Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
By Cynthia A. Ch…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
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
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
If used correctly, these new analytical methods can reduce analysis and product development time.
ABSTRACT
Monoclonal antibodies represent a significant portion of sales in the biopharma…
Article
FDA Framework Spurs Advanced Therapies
“We have customers in both early- and late-stage clinical development, some of whom would be seeking to leverage this new guidance,” says Keene.
In addition, because Lonza takes a science-based…
Article
Scaling Up Novel Therapies
Scaling Up Novel Therapies
Platform processes have improved monoclonal antibody scale-up. Can they do the same for personalized therapies?
By Agnes S…
Article
Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
Article
Witnessing Major Growth in Next-Generation Antibodies
A few have already been approved, and many more are in preclinical and clinical development. There are numerous challenges that need to be overcome first, however, and the full impact of next-generati…