Search results for " meeting"
Article
The Bullish Outlook for Biosimilars
Feb 01, 2015
By Jill E. Sackman, PhD, Michael J. Kuchenreuther, PhD
BioPharm International
There are several important reasons for stakeholders to be optimistic about prospects for b…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
They made us an “unofficial partner” of a project where we could attend meetings and receive feedback. This led to discussions with other regulatory bodies as well, such as EMA and PMDA. An essential …
Article
Trends in Single-use Bioreactors
Representatives from industry supplier companies address innovations, reliability, barriers to adoption, and the role of singIe-use bioreactors in bioprocessing.
By: Randi Hernandez
Whil…
Article
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh
BioPharm Inter…
Article
DoE Provides Benefits, but Preparation Is Necessary
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 28-29
Using a design-of-experiment (DoE) approach allows a formulation development scientist t…
Article
Biopharma Manufacturers Respond to Ebola Crisis
FDA also is working with WHO’s International Coalition of Medicines Regulatory Authorities (ICMRA) to facilitate testing of experimental treatments and to provide more flexibility for meeting manufact…
Article
A Q&A With Phil Lester, co-organizer of the HTPD Conference
PDF: This is the third HTPD meeting. Can you tell us about the genesis of the conference?
Phil: Back in 2008 high throughput process development was an emerging technology and I could see it was g…
Article
Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Otherwise, cell culture, purification, and drug product development may put undue importance on meeting certain criteria that are ultimately not critical, resulting in suboptimal processes that make u…