Search results for "2014"
Article
Downstream Processing Continues to Worry CMOs
In fact, since the notable increase in capacity problems for CMOs due to downstream processing in 2014, biotherapeutic developers’ own problems have edged up, from 42.6% reporting “serious” or “some” …
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
79–88 (2014).
2. K.W. Kwon et al., Lab Chip 7, pp. 1461–1468 (2007).
3. H.S. Yang et al., Cell Transplant. 19, pp. 1123–1132 (2010).
4. R. Pape et al., Arterioscler. Thromb. Vasc. Biol. 28…
Article
Best Practices in Qualification of Single-Use Systems
66, Application of Single-Use Systems in Pharmaceutical Manufacturing (PDA, 2014).
2. H. Domininghaus, Plastics for Engineers, Materials, Preperties, Applications (Hanser Publishers, 1993).
3.…
Article
Aseptic Processing: Keeping it Safe
Acucena, “Defining a Strategy for the Validation and Qualification of Sterile Filtration Processes of Investigational Medicinal Compounds,” presentation at the PDA Metro Chapter Dinner, March 4, 2014.
Article
Improving PAT for Biologics
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) approach to pharmaceutical manufacturing is the implementation of process ana…
Article
New Era for Generic Drugs
Nov 1, 2014
By: Jill Wechsler
BioPharm International
Volume 11, Issue 27, pp. 8-10
The 30th anniversary of the Hatch-Waxman Act in September generated widespread recognition of how the leg…
Article
High-Throughput Process Development in an Historical Environment
The challenge in the very first HTPD Olympiad 2014 was to develop a purification process for a Dab expressed in E. coli using high-throughput workflows for maximized Dab purity and yield. Six teams si…
Article
Relationship Building at Top of Mind for Clients
Aug 1, 2014
By: Eric Langer
BioPharm International
Volume 27, Issue 8, pp. 12-14
Contract manufacturing organizations (CMOs) should have the technical expertise to be considered by clients…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
He notes, though, that until 2014, MALS detectors did not keep pace by decreasing the dispersion to match the narrower eluting peaks. The µDAWN MALS detector introduced in March 2014 by Wyatt Technolo…
Article
FDA and EMA Extend QbD Parallel-Assessment Pilot Program
The agencies have agreed that there are further QbD areas that warrant additional inter-agency harmonization and expect to publish more guidance documents in 2014.
The program is open to applicatio…