GMP is an acronym used in two instances: Guanine Monophosphate ( a biomolecular consisting of a phosphate group, pentose sugar ribose, and guanine base), and Good Manufacturing Practice (the system used to ensure the high quality manufactured products).
DATE: December 19, 2017TIME: 8:00 AM PT, 11:00 AM ETIn its chapter on TOC for WFI and PW, the European Pharmacopoeia calls for complete TOC oxidation. This webinar discusses the i...
DATE: December 12, 2017TIME: 10:00AM PTSince their discovery, dendritic cells (DCs) have demonstrated a central role in the development of effective immune responses. Their unique abili...
DATE: November 28th, 2017TIME: 6:00AM PT, 9:00AM ETThe work of ICH has significance for pharmaceutical manufacturers globally. This webinar discusses the key validation ch...
DATE: October 31st, 2017TIME: 8:00AM PT, 11:00AM ETThis webinar discusses typical sources of water system TOC and conductivity excursions in pharmaceutical water systems a...
DATE: October 26, 2017TIME: 12:00 PM PDTThis presentation will focus on recent advances in cellular therapy—from mesenchymal stromal cells (MSCs) to tumor-specific T-cells. More s...
DATE: October 4th, 2017
TIME: 6:00AM PT, 9:00AM ET
The new revision of the European Pharmacopoeia chapter on WFI now permits the generation of WFI using double-pass osmosis ...
DATE: September 5, 2017TIME: 8:00AM PT, 11:00AM ETA recent report indicates that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry in 2016 cited def...
DATE: July 19, 2017TIME: 7:00am PT, 10:00am ET, 4:00pm CETAccording to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on dat...
DATE: July 12th 2017TIME: 9:00AM SGT, 12:00PM AEDTORDATE: July 11th, 2017TIME: 6:00PM PDTEvaluation of different options will be presented for scaling up large qua...
DATE: May 17, 2017TIME: 10:30am PT, 1:30pm ETNeurons derived from human pluripotent stem cells (hPSCs) and primary rodent neurons both are excellent resources for disease modeling and d...
Lentiviral vectors have become the center of attention for its use as gene transfer vectors in gene therapy. Here, we have developed a new lentiviral production system for the clinical grade...
The isolation of broadly-neutralizing antibodies from HIV-1 infected individuals raises the hope that a vaccine may elicit a similar immune response. These antibodies target the only viral pr...
We have developed a semi-automated, high-throughput transient expression and purification system that yields milligram quantities of hundreds of proteins weekly. Starting from a glycerol stoc...
Neurons derived from human pluripotent stem cells (hPSCs) and primary rodent neurons both are excellent resources for disease modeling and drug screening. Human PSCs derived neural stem...
This panel will discuss quality requirements of ancillary materials used in cell therapy manufacturing, relevant standards and how requirements vary by phase. Participants will learn wh...
DATE: November 3, 2016
TIME: 9:00AM PT, 12:00PM ET
Patient safety is at the core of biopharmaceutical manufacturing operations. Ensuring virus safety of biopharmaceutical products p...
DATE: September 8, 2016
TIME: 8:00am PST, 11:00am EST
The FDA’s 21 CFR Part 11 guidance on the use of electronic records for data retention or submission is clear. With ...
Neurons derived from human pluripotent stem cells (hPSCs), including embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs), are excellent resources for disease modeling and d...
Buerger’s disease, commonly known as Thromboangiitis obliterans, is a non-atherosclerotic, segmental inflammatory disease that can affect the small and medium-sized arteries of young pe...
July 13, 2016, 8:00am PT, 11:00am ET, 4:00pm GMT
Changes in the classification standard, ISO 14644-1:2015, will have an impact on both the number of sample points needed to classif...
DATE: June 14, 2016TIME: 8am Pacific time, 11am Eastern timeImproving systems for rapid small-scale protein purification and analysis in order to obtain sample numbers for statist...
April 14, 2016, 7:00am PT, 10:00am ET, 2:00pm GMT
Whether cells are being used to manufacture a therapeutic drug product or for pharmacology, measuring the cell viability and concentration...
DATE: December 19, 2017TIME: 8:00 AM PT, 11:00 AM ETIn its chapter on TOC for WFI and PW, the European Pharmacopoeia calls for complete TOC oxidation. This webinar discusses the i...
DATE: December 12, 2017TIME: 10:00AM PTSince their discovery, dendritic cells (DCs) have demonstrated a central role in the development of effective immune responses. Their unique abili...
DATE: November 28th, 2017TIME: 6:00AM PT, 9:00AM ETThe work of ICH has significance for pharmaceutical manufacturers globally. This webinar discusses the key validation ch...
DATE: October 31st, 2017TIME: 8:00AM PT, 11:00AM ETThis webinar discusses typical sources of water system TOC and conductivity excursions in pharmaceutical water systems a...
DATE: October 26, 2017TIME: 12:00 PM PDTThis presentation will focus on recent advances in cellular therapy—from mesenchymal stromal cells (MSCs) to tumor-specific T-cells. More s...
DATE: October 4th, 2017
TIME: 6:00AM PT, 9:00AM ET
The new revision of the European Pharmacopoeia chapter on WFI now permits the generation of WFI using double-pass osmosis ...
DATE: September 5, 2017TIME: 8:00AM PT, 11:00AM ETA recent report indicates that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry in 2016 cited def...
DATE: July 19, 2017TIME: 7:00am PT, 10:00am ET, 4:00pm CETAccording to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on dat...
DATE: July 12th 2017TIME: 9:00AM SGT, 12:00PM AEDTORDATE: July 11th, 2017TIME: 6:00PM PDTEvaluation of different options will be presented for scaling up large qua...
DATE: May 17, 2017TIME: 10:30am PT, 1:30pm ETNeurons derived from human pluripotent stem cells (hPSCs) and primary rodent neurons both are excellent resources for disease modeling and d...
Lentiviral vectors have become the center of attention for its use as gene transfer vectors in gene therapy. Here, we have developed a new lentiviral production system for the clinical grade...
The isolation of broadly-neutralizing antibodies from HIV-1 infected individuals raises the hope that a vaccine may elicit a similar immune response. These antibodies target the only viral pr...
We have developed a semi-automated, high-throughput transient expression and purification system that yields milligram quantities of hundreds of proteins weekly. Starting from a glycerol stoc...
Neurons derived from human pluripotent stem cells (hPSCs) and primary rodent neurons both are excellent resources for disease modeling and drug screening. Human PSCs derived neural stem...
This panel will discuss quality requirements of ancillary materials used in cell therapy manufacturing, relevant standards and how requirements vary by phase. Participants will learn wh...
DATE: November 3, 2016
TIME: 9:00AM PT, 12:00PM ET
Patient safety is at the core of biopharmaceutical manufacturing operations. Ensuring virus safety of biopharmaceutical products p...
DATE: September 8, 2016
TIME: 8:00am PST, 11:00am EST
The FDA’s 21 CFR Part 11 guidance on the use of electronic records for data retention or submission is clear. With ...
Neurons derived from human pluripotent stem cells (hPSCs), including embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs), are excellent resources for disease modeling and d...
Buerger’s disease, commonly known as Thromboangiitis obliterans, is a non-atherosclerotic, segmental inflammatory disease that can affect the small and medium-sized arteries of young pe...
July 13, 2016, 8:00am PT, 11:00am ET, 4:00pm GMT
Changes in the classification standard, ISO 14644-1:2015, will have an impact on both the number of sample points needed to classif...
DATE: June 14, 2016TIME: 8am Pacific time, 11am Eastern timeImproving systems for rapid small-scale protein purification and analysis in order to obtain sample numbers for statist...
April 14, 2016, 7:00am PT, 10:00am ET, 2:00pm GMT
Whether cells are being used to manufacture a therapeutic drug product or for pharmacology, measuring the cell viability and concentration...
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