FDA’s Approach to Adventitious-Agent Testing of Cell Substrates and Viral Vaccines: Traditional and Novel Methods Keith Peden Division of Viral Products

10/26/11 . 1 . Adventitious Agent Testing of Novel Cell Substrates for Vaccine Manufacture Arifa S. Khan, PhD. Division of Viral Products Office of Vaccines Research ...

Peptone and Complex Media as a Source of Mycoplasma Contamination Plant-derived proteins are not adventitious agent free!

... study of equivalence New master cell bank or seed Affect product sterility assurance Changes in: Qualitative or quantitative formulation/specs Virus/adventitious agent ...

... process Information on animal-derived components not provided Sourcing and history information - “Source Material” Description and results of adventitious agent ...

... Components present due to process conditions : Host-cell-derived components Process-derived components Components present due to contamination : Adventitious agent ...

... for safety-related functions (e.g. viral clearance) Testing for safety-related purposes (viral loads, bioburden, removal of residual substances, etc.) Adventitious agent ...

Establishing Cell Banks to Support Product Manufacturing: adventitious agent testing. Adequate Characterization of Investigational Cellular Product: multi ...

Adventitious Agents . SV40 in Polio; An “adventitious viral agent”. Was present in monkey kidney cells used to grow polio virus.

Inactivation Kinetics Adventitious Agents SV40 in Polio An “adventitious viral agent”. Was present in monkey kidney cells used to grow polio virus.

... include acute onset of chills, fever, dyspnea, pleuritic chest pain, cough, adventitious ... Disease Transmission of Infectious Disease Interaction of Host, Infectious Agent ...

Methods of micropropagation Axillary branching Adventitious shoot formation Somatic ... kanamycin Only those cells able to grow in the presence of the selective agent ...

... 30 years e.g., Herpes B (CHV-1), prions Oncogenic potential could be oncogene or oncogenic agent e.g., HPV-18, MPMV genomes in HeLa cells Unexpected (adventitious ...

Shoot tip: The shoot apical meristem from either axillary or adventitious buds can be ... acids or buffers could be beneficial in some circumstances) A solidifying agent ...

การทดสอบการปนเปื้อนของเชื้อต่างๆ (Adventitious agent testing) ...

... Minerals Sugar Organic ‘growth factors’ Growth regulators Gelling agent ... Terminal extension Lateral / Axillary buds Adventitious (de novo, re-differentiation ...

... PCR with TAQ-MAN Application Product Quality - Complex Biological Product Characterization - Release Testing - Manufacturing process monitoring - Adventitious Agent ...

Adventitious Presence . Unintended presence of something other than the desired crop ... The cost of such testing will be borne by the applicable certifying agent and ...

... Cell lines may contain pathogens (naturally or through contamination by adventitious ... of Risk Group 2 or higher, depending on nature of the work and amount of agent ...

Surfactants - surface active agent Science of Cleaning Penetrating and Wetting ... vapour pressure) Deplete reservoirs Bulk gases Surface overlayers (e.g. adventitious ...