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...
Human pluripotent stem cells (hPSCs) and their derivatives are increasingly being used in industry to gain a competitive edge in drug discovery and a new wave of biotechnology start-up compan...
Regenerative medicine therapeutics aimed at restoring normal cell function due to trauma and disease are gaining increasing momentum in clinical trials. For this purpose, lentivirus-based gen...
Pluripotent stem cell (PSC) culture at commercial scale requires a shift from the current manual processing methods and costly materials to deliver affordable differentiated cell products in...
The availability of well-characterised monoclonal antibodies (mAbs) detecting cell-surface epitopes on human pluripotent stem cells (hPSCs) provides useful research tools to investigate the c...
Since 1993, Gibco™ B-27™ Supplement and Neurobasal™ Medium has been the trusted standard for a variety of neuronal culture applications, with citations in more than 11,000 p...
DATE: June 28, 2017TIME: 7:00am PT, 10am ETAs gene therapy approaches usually require large amounts of AAV vectors for clinical use, few manufacturing processes have been repo...
DATE: May 31, 2017TIME: 6:00PM PDT, 9:00AM SGT, 12:00PM AEDTGain insights into T-cell expansion, viral vector production and scaling production of mesenchymal stem cells (MSCs) through...
A hardware architecture was developed specifically to facilitate collaborative development and dissemination of microfluidic experiments. Modular pressure regulators, incubators, and chip-to-...
R&D in life science, material science, and chemistry is burdened by fragmented and unstructured data (“spreadsheet hell”), and ambiguous or unrecorded methodological data. Thi...
Gain insights into T-cell expansion, viral vector production and scaling production of mesenchymal stem cells (MSCs) through the use of a functionally closed, automated, cell culture process....
Reliable autologous expression of recombinant human proteins - from gene sequence to the expressed and purified protein - in human or CHO cells is essential for many aspects of biomedical res...
DATE: April 6, 2017TIME: 3:00PM GMT, 7:00AM PT, 10:00AM ETThe Edinburgh Genome Foundry (EGF) is a newly established facility of the University of Edinburgh and ass...
Development of robust purification processes requires significant time and resources. In addition, steadily increasing demands from regulatory authorities for better understanding and control...
The mission of the California Institute for Regenerative Medicine (CIRM) is to accelerate stem cell treatments to patients with unmet medical needs. With $3 billion in funding and 300 a...
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...
The Alliance for Regenerative Medicine (ARM) is the preeminent global advocate for regenerative and advanced therapies. ARM fosters research, development, investment and commercialization of ...
The recent Zika virus outbreak highlights the need for low-cost diagnostics that can be rapidly developed for distribution and use in pandemic regions. In early 2016 we developed a pipe...
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...
Learning Objectives:
Describe the various causative factors of ketosis and the physiological processes that lead to acidosis, a life threatening condition
Summarize the biochemical diff...
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 ...
Despite FDA-approved vaccines and antivirals, seasonal and pandemic influenza remains a serious threat associated with substantial morbidity and mortality. The present modalities and va...
A major challenge for the clinical application of pluripotent stem cell therapy for neurodegenerative diseases is large-scale manufacturing and cryopreservation of neurons and glia that can b...
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...
Human pluripotent stem cells (hPSCs) and their derivatives are increasingly being used in industry to gain a competitive edge in drug discovery and a new wave of biotechnology start-up compan...
Regenerative medicine therapeutics aimed at restoring normal cell function due to trauma and disease are gaining increasing momentum in clinical trials. For this purpose, lentivirus-based gen...
Pluripotent stem cell (PSC) culture at commercial scale requires a shift from the current manual processing methods and costly materials to deliver affordable differentiated cell products in...
The availability of well-characterised monoclonal antibodies (mAbs) detecting cell-surface epitopes on human pluripotent stem cells (hPSCs) provides useful research tools to investigate the c...
Since 1993, Gibco™ B-27™ Supplement and Neurobasal™ Medium has been the trusted standard for a variety of neuronal culture applications, with citations in more than 11,000 p...
DATE: June 28, 2017TIME: 7:00am PT, 10am ETAs gene therapy approaches usually require large amounts of AAV vectors for clinical use, few manufacturing processes have been repo...
DATE: May 31, 2017TIME: 6:00PM PDT, 9:00AM SGT, 12:00PM AEDTGain insights into T-cell expansion, viral vector production and scaling production of mesenchymal stem cells (MSCs) through...
A hardware architecture was developed specifically to facilitate collaborative development and dissemination of microfluidic experiments. Modular pressure regulators, incubators, and chip-to-...
R&D in life science, material science, and chemistry is burdened by fragmented and unstructured data (“spreadsheet hell”), and ambiguous or unrecorded methodological data. Thi...
Gain insights into T-cell expansion, viral vector production and scaling production of mesenchymal stem cells (MSCs) through the use of a functionally closed, automated, cell culture process....
Reliable autologous expression of recombinant human proteins - from gene sequence to the expressed and purified protein - in human or CHO cells is essential for many aspects of biomedical res...
DATE: April 6, 2017TIME: 3:00PM GMT, 7:00AM PT, 10:00AM ETThe Edinburgh Genome Foundry (EGF) is a newly established facility of the University of Edinburgh and ass...
Development of robust purification processes requires significant time and resources. In addition, steadily increasing demands from regulatory authorities for better understanding and control...
The mission of the California Institute for Regenerative Medicine (CIRM) is to accelerate stem cell treatments to patients with unmet medical needs. With $3 billion in funding and 300 a...
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...
The Alliance for Regenerative Medicine (ARM) is the preeminent global advocate for regenerative and advanced therapies. ARM fosters research, development, investment and commercialization of ...
The recent Zika virus outbreak highlights the need for low-cost diagnostics that can be rapidly developed for distribution and use in pandemic regions. In early 2016 we developed a pipe...
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...
Learning Objectives:
Describe the various causative factors of ketosis and the physiological processes that lead to acidosis, a life threatening condition
Summarize the biochemical diff...
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 ...
Despite FDA-approved vaccines and antivirals, seasonal and pandemic influenza remains a serious threat associated with substantial morbidity and mortality. The present modalities and va...
A major challenge for the clinical application of pluripotent stem cell therapy for neurodegenerative diseases is large-scale manufacturing and cryopreservation of neurons and glia that can b...
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