Search results for " 2016" in Articles / App Notes
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
In 2016, for example, the company made functional groups more accountable for reliability so that the supply-chain function could take more of a supportive role.
This has helped the functional …
Article
From Darwin to Recombinant Fc Multimers
LFB has made a big commitment to expand its manufacturing capacity with an investment of €300M, and initiated a new facility project in Arras, north of France in 2016, with an objective to fractionate…
Article
Witnessing Major Growth in Next-Generation Antibodies
Visiongain, “Next Generation Antibody Therapies Market Forecast 2016-2026,” Press Release, May 11, 2016.
Article
Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics.
By Susan Haigney
Critical quality attributes (CQAs) are used in biop…
Article
Ensuring the Biological Integrity of Raw Materials
16, 2016.
2. M. Wisher, Bioprocess Int. 11 (9), pp. 12–15 (October 2013).
3. O.-W. Merten, Cytotechnol. 39, pp. 91–116 (2002).
4. J.G. Victoria et al., J. Virol. 84 (12), pp. 6033–6040 (Ju…
Article
Evaluating E&L Studies for Single-Use Systems
Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.
By Irene Cecchini, Daniele Mastroianni, Silvia Rocchi, Gabriella Angiuoni
Biop…
Article
Defining Risk Assessment of Aseptic Processes
FDA, Draft Guidance for Industry, Insanitary Conditions at Compounding Facilities (CDER Office of Compliance, August 2016).
Article
Innovation vs. Capacity: How CMOs Compete
PharmSource, Contract Dose Manufacturing Industry by the Numbers: Composition, Size, Market Share and Outlook-2016 Edition (PharmSource, 2016).
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
Article
A Q&A with Eric Langer: CMOs Embrace New Technology
Process Development Forum speaks with Eric Langer, President and Managing Partner at BioPlan Associates, and the author of a number of biopharma studies, about the 2016 13th Annual Report and Survey…