Search results for " 2015"
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
By Feliza Mirasol
ARTMOIS/STOCK.ADOBE.COM
Biopharmaceutical manufactu…
Article
Science Focus Fuels Successful Process Development for Startups
But he notes that patience can be amply rewarded, as it was for him when he was at Incyte Corporation, where the stock price rose from $2–3 per share in 2009 to more than $110 per share in 2015.
A…
Article
Modeling the Degradation of mAb Therapeutics
Modeling the Degradation of mAb Therapeutics
Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
By Anurag S. Rathore, Rohit Bansal
…
Article
Fifteen Years of Progress: Biopharmaceutical Industry Survey Results
10-14 (February 2015).
6. R.A. Rader, BIOPHARMA: Biopharmaceutical Products in the U.S. Market, 2nd edition (Biotech. Info. Inst., June 2003).
7. R.A. Rader, BIOPHARMA: Biopharmaceutical P…
Article
Challenges in Cell Harvesting Prompt Enhancements
Challener, BioPharm International 28 (5) 2015.
3. H.F. Liu et. al, “Recovery and Purification Process Development for Monoclonal Antibody Production,” MAbs online, DOI: 10.4161/mabs.2.5.12645, S…
Article
Understanding Validation and Technical Transfer, Part 3
EC, Consultation Document Good Manufacturing Practice for Advanced Therapy Medicinal Products [2] (European Commission, 2015).
4. FDA, Guidance for Industry Guidance for Human Somatic Cell The…
Article
Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…
Article
Techniques for Improving Process Development for Exosome-Derived Therapeutics
Founded in 2015, this company’s primary focus is to develop therapeutics with exosomal cargo and engineered surface ligands that can affect diseases, especially those with “undruggable” targets. Speci…
Article
Process Development: What May Lie Ahead in 2018?
The figures for all new drug approvals are in line with the record numbers of approvals from 2014 and 2015, and the good news may continue into 2018.
As drug companies look for the fastest pathwa…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Since 2015, the company has delivered a 100% “launch on time” success rate for new products. This is based on a supply chain that can deliver these new products to customers following regulatory appro…