Search results for "2014" in Articles / App Notes
Article
Vaccine Development Faces Urgency and Challenges
Global outbreaks energize vaccine R&D and drive production modernization.
By Jill Wechsler
The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika vir…
Article
A Q&A With Jeff Carter on Trends in Single-Use Technologies
Nonetheless, when we do have an industry best practice it will likely have origins from the original BPOG document from 2014.
What are the main challenges going forward?
One of the key challeng…
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA’s Center for Drug Evaluation and Research (CDER) approved 45 new molecular entities (NMEs) and biotech therapies in 2015, beating the near-record set in 2014. FDA’s Center for Biologics Evaluation…
Article
Biopharma in 2015: A Year for Approvals and Innovations
Twenty approvals (39%) went to biological drugs—up from 35% in 2014 and 22% in 2013—which confirms the growing importance of biopharmaceuticals in the industry pipeline.1
Process Development Forum …
Article
CMOs Concerned With Cost of Single-Use Equipment
Suppliers indicate prices for single-use equipment are likely to increase.
By Eric Langer
Contract manufacturing organizations (CMOs) have been enthusiastic adopters of single-use technologi…
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Since the first therapeutic antibody came onto the market in 1986, up to the end of 2014, 47 products have been approved in the United States or Europe for a number of diseases including various types…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
Editors’ Note: This article is based on a topic addressed during the 6th Pharmaceutical Inspection Co-operation Scheme (PIC/S) Expert Circle on APIs meeting, held in Rome in May 2014 and hosted by the…
Article
Breakthrough Drugs Raise Development and Production Challenges
FDA acting commissioner Stephen Ostroff pointed out at the annual meeting of the Food & Drug Law Institute (FDLI) in April 2015 that two-thirds of 2014’s near-record 51 new molecular entities (NMEs) t…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
PDA, Technical Report 68, Risk-Based Approach for Prevention and Management of Drug Shortages (PDA, 2014).
Article Details
BioPharm International
Vol. 28, No. 7
Pages: 34–36
Citati…
Article
Biopharma Advances Demand Specialized Expertise
…g processes?
McNally (PPD Consulting): FDA established a new Office of Pharmaceutical Quality in 2014, which we anticipate will have major impacts on the biopharmaceutical development and manufact…