3 Key Industry Updates Showcased Next Month
Hear more from GSK Vaccines, Tempris Sensor Control and Regeneron Pharmaceuticals.
Iselin, NJ, October 12, 2017 --(PR.com)-- SMi’s Lyophilization USA will strengthen knowledge of lyophilization productivity as well as discovering the traditional approaches for process design and scale up, present cutting-edge technologies such as phase separation in lyophilized protein formulations and product temperature. www.lyophilization-usa.com/prc
Hear case studies from a selection of industry pioneers currently implementing freeze-drying processes, at the heart of freeze-drying technology and regulation.
1. Assessing Phase Separation in Lyophilized Protein Formulations
Lyophilization of pharmaceutical proteins is often the only processing method that provides requisite long-term product stability. Freezing and drying, however, this can cause acute damage to proteins. While great efforts are placed on developing a formulation and suitable lyophilization cycle, incompatibilities among components through freezing and drying have been almost completely ignored. Presented by: Dr. Kelly Forney Stevens, Drug Product Development, GSK Vaccines
2. Lyophilization Process Development, Scale-up & Technology Transfer Strategies
When a product is developed in the laboratory setting or using small-scale equipment, such expertise are particularly valuable during technology transfer and scale-up of lyophilization processes. While these operations generally run smoothly, there are times when conditions in the laboratory-scale setting cannot be duplicated at commercial scale; production, formulation, container, or equipment-related problems arise. The processes of Lyophilization can go wrong, especially those in larger scales, which cannot be mimicked easily. *Presented by: Charlie Tang, Director, Formulation Development, Regeneron Pharmaceuticals
3. How Wireless Product Temperature Monitoring is Used in Commercial Lyophilization Today
Product temperature is the most important critical quality attribute in a freeze-drying process. During the process, product temperature cannot be controlled directly, but is determined by a combination of process and product parameters. The shelf temperature and chamber pressure are controlled directly based on the user-defined recipe, and constitute the main variables for achieving a suitable product temperature over time profile. Parameters have an influence, such as the geometry of the container system, the extent of radiative heat transfer to the vials, and the physicochemical state of the product. Due to this multitude of factors, it is very difficult to keep all product units within the batch at a target product temperature throughout the process. This challenge can be overcome by application of Tempris, a process analytical technology capable of measuring the product temperature in real time. *Presented by: Anton Mangold, Managing Director, Tempris
These are just some of the unmissable program highlights for 2017. Visit the website to see a full speaker line-up and detailed conference agenda. www.lyophilization-usa.com/prc
For those looking to attend, check out the booking options online.
SMi Presents the 3rd Annual Conference on…
Lyophilization USA
Date: November 16th – 17th 2017
Location: Iselin, New Jersey
Website: www.lyophilization-usa.com/prc
Sponsored by: ELLAB | Schott | Tempris | W.L. Gore & Associates, Iinc
Contact Information:
For all media inquiries contact Pavan Solanki on Tel: +44 (0)20 7827 6048 / Email: psolanki@smi-online.co.uk
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk
Hear case studies from a selection of industry pioneers currently implementing freeze-drying processes, at the heart of freeze-drying technology and regulation.
1. Assessing Phase Separation in Lyophilized Protein Formulations
Lyophilization of pharmaceutical proteins is often the only processing method that provides requisite long-term product stability. Freezing and drying, however, this can cause acute damage to proteins. While great efforts are placed on developing a formulation and suitable lyophilization cycle, incompatibilities among components through freezing and drying have been almost completely ignored. Presented by: Dr. Kelly Forney Stevens, Drug Product Development, GSK Vaccines
2. Lyophilization Process Development, Scale-up & Technology Transfer Strategies
When a product is developed in the laboratory setting or using small-scale equipment, such expertise are particularly valuable during technology transfer and scale-up of lyophilization processes. While these operations generally run smoothly, there are times when conditions in the laboratory-scale setting cannot be duplicated at commercial scale; production, formulation, container, or equipment-related problems arise. The processes of Lyophilization can go wrong, especially those in larger scales, which cannot be mimicked easily. *Presented by: Charlie Tang, Director, Formulation Development, Regeneron Pharmaceuticals
3. How Wireless Product Temperature Monitoring is Used in Commercial Lyophilization Today
Product temperature is the most important critical quality attribute in a freeze-drying process. During the process, product temperature cannot be controlled directly, but is determined by a combination of process and product parameters. The shelf temperature and chamber pressure are controlled directly based on the user-defined recipe, and constitute the main variables for achieving a suitable product temperature over time profile. Parameters have an influence, such as the geometry of the container system, the extent of radiative heat transfer to the vials, and the physicochemical state of the product. Due to this multitude of factors, it is very difficult to keep all product units within the batch at a target product temperature throughout the process. This challenge can be overcome by application of Tempris, a process analytical technology capable of measuring the product temperature in real time. *Presented by: Anton Mangold, Managing Director, Tempris
These are just some of the unmissable program highlights for 2017. Visit the website to see a full speaker line-up and detailed conference agenda. www.lyophilization-usa.com/prc
For those looking to attend, check out the booking options online.
SMi Presents the 3rd Annual Conference on…
Lyophilization USA
Date: November 16th – 17th 2017
Location: Iselin, New Jersey
Website: www.lyophilization-usa.com/prc
Sponsored by: ELLAB | Schott | Tempris | W.L. Gore & Associates, Iinc
Contact Information:
For all media inquiries contact Pavan Solanki on Tel: +44 (0)20 7827 6048 / Email: psolanki@smi-online.co.uk
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world's most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk
Contact
SMi Group
Pav Solanki
+44 (0) 20 7827 6048
http://www.lyophilization-usa.com/prc
Pav Solanki
+44 (0) 20 7827 6048
http://www.lyophilization-usa.com/prc
Contact
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