Characterization of virus-like particles in GARDASIL® by cryo transmission electron microscopy
- Qinjian Zhao, C. Potter, R. Sitrin
- BiologyHuman Vaccines & Immunotherapeutics
- 1 March 2014
Cryo-transmission electron microscopy (cryoTEM) is a powerful characterization method for assessing the structural properties of biopharmaceutical nanoparticles, including Virus Like Particle-based…
Considerations for Optimization of High-Throughput Sequencing Bioinformatics Pipelines for Virus Detection
- Christophe Lambert, Cassandra L Braxton, Arifa S. Khan
- BiologyViruses
- 27 September 2018
The collective considerations discussed in this paper aid toward optimization of data analysis pipelines for virus detection by HTS.
Systematic evaluation of in vitro and in vivo adventitious virus assays for the detection of viral contamination of cell banks and biological products.
- J. Gombold, Stephen Karakasidis, R. Sheets
- BiologyVaccine
- 19 May 2014
Approaches to the release of a master cell bank of PER.C6 cells; a novel cell substrate for the manufacture of human vaccines.
A Master Cell Bank (MCB) of PER.C6 cell line used for the manufacture of vaccine vector supporting a number of IND submissions for Phase I clinical trials over a three-year period during which the panel of PCR testing applied to the MCB has been judiciously expanded.
Adventitious Agent Risk Assessment Case Study: Evaluation of RotaTeq® for the Presence of Porcine Circovirus
- C. Ranucci, T. Tagmyer, P. Duncan
- MedicinePDA journal of pharmaceutical science and…
- 1 November 2011
The methodology and rationale developed to thoroughly assess key starting materials, product intermediates, and final product to demonstrate the absence of infectious PCV are described and could be applied to assess the validity of other adventitious agent risks encountered in biological processes and products.
Defining a Sample Preparation Workflow for Advanced Virus Detection and Understanding Sensitivity by Next-Generation Sequencing
- Christopher J Wang, S. F. Feng, P. Duncan
- BiologyPDA journal of pharmaceutical science and…
- 1 November 2014
It is demonstrated that at defined spike levels, nucleic acids from a panel of model viruses spiked into representative cell lysate and viral vaccine harvest samples can be confidently recovered by next-generation sequencing.
Detection breadth and limits for potential adventitious/endogenous contaminants in biopharmaceutical processes: a reality check for innovative methods.
- P. Duncan, L. McKerral, S. Feng, P. Tsai
- BiologyDevelopments in Biologicals
- 2006
The "gold standards" among diagnostic tests used to detect some potential adventitious and endogenous contaminants in human biologics and vaccines are addressed, reflecting on the breadth as well as limits of detection of these assays.
Modeling an Approach To Define Sensitivity of Viral Detection in Sample Matrices—Examples with Microarray Readout
- S. F. Feng, C. Jaing, James B Thissen, Christopher Wang, P. Duncan
- Computer SciencePDA journal of pharmaceutical science and…
- 1 November 2014
An approach to establishing the suitability of advanced nucleic-acid-based detection systems for characterization of cell substrates and production cultures is evaluated and a means by which technology users, developers, and regulators may consider the critical performance attributes of novel detection technologies is suggested.
Summary of the Advanced Virus Detection Technologies Users Group Efforts—2013
- P. Duncan
- Computer SciencePDA journal of pharmaceutical science and…
- 1 November 2014
An informal consortium of scientists from the biopharmaceutical industry, academia, and government agencies, including regulators, coalesced during 2013 to further explore advanced virus detection…
Role of Analytics in Viral Safety
A pathway forward to a new paradigm for adventitious agent testing exists in which detection of a broader array of potential adventitious agents might be included in the testing, with adequate sensitivity to provide the needed assurance of verification that there has been no catastrophic breach, in the context of the overall process, design, and adherence to cGMP.
...
...