The new Webinar Series kicks-off the INTERPHEX 2015 year of industry growth; an initiative designed to grow the Biopharmaceutical and Pharmaceutical industry through innovative solutions. Join us for our complimentary webinar series from the convenience of your own desk.
Listen to recordings of past webinars from INTERPHEX's 2013-2014 Webinar Series. The Webinar Series aims to support INTERPHEX's robust conference program and will serve as the industry's year round education resource, covering the hottest topics and trends.
Taking Life Sciences to the Cloud
Date: June 12, 2014
Time: 2:00pm-3:00pm (-5 GMT)
Speakers: John Niziolek, Practice Leader, Compliance, Cornerstone OnDemand and Aaron Weinstein, Senior Director - Validation Services, IPS - Integrated Project Services
Life science organizations face unprecedented compliance and transparency expectations today. In order to meet requirements, focusing on the development of your people has to be just as important as your improving upon your product. But is there a way to continually develop your staff to meet new requirements without it interfering with your core business?
Register for “Taking Life Sciences to the Cloud” and learn how the cloud can better address validation compliance requirements, empower your employees and improve organizational performance. Aaron Weinstein, Senior Director - Validation Services, and John Niziolek, Cornerstone OnDemand’s Compliance Practice Leader, will lead this not-be-missed discussion for those in the life sciences industry. Webinar attendees will gain valuable information:
- To describe what The Cloud is and how it is used by the life sciences industry.
- To deliver an overview of the challenges in utilizing The Cloud in a regulated environment and how to tackle them.
- To detail some of the advantages of moving to Cloud-based systems.
Performance and Economics Analysis of Fully Automated Single-use Tangential Flow Filtration Process
Date: June 5, 2014
Time: 11:00am EDT
Speaker: Engin Ayturk, Ph.D., BioPharm Applications R&D, PALL Corporation
Fully automated design approach to single-use tangential flow filtration (SUTFF) brings real-time process control, monitoring, flexibility and reliability in manufacture. Gamma irradiated Cadence™ Single-use TFF modules are scalable and easy to use, and form part of the fully automated UF/DF solution from Pall Life Sciences. This approach is well suited for R&D, clinical manufacturing or commercial production up to several hundreds of liters. The system can be implemented in multi-purpose or multi-product facilities, or CMOs (flexible facilities), for applications with containment or safety issues and processes targeting increased productivity. In addition to the application data showcasing SUTFF module performance, a detailed process economics modeling analysis will compare single-use versus conventional stainless steel TFF technologies and quantify the impact of key process parameters. In this context, the modeling strategy and the key points of SUTFF process economics will be presented via sensitivity and benchmark analyses under the main cost of goods categories of capital, materials, consumables, labor and facility operating costs.
Webinar learning objectives include:
- Fully automated Allegro™ Single-use TFF system capabilities.
- Performance, scalability, repeatability and ease-of-use evaluation of Cadence™ Single-use TFF modules.
- Quantitative cost benchmark analysis between conventional TFF and single-use TFF.
Single Pass Tangential Flow Filtration for Bioprocessing
Date: May 21, 2014
Time: 2:00pm EST
Speaker: Joseph Parrella, Biomanufacturing Engineer, Biomanufacturing Sciences Network, EMD Millipore
Downstream purification processes for biopharmaceutical products are being challenged by increasing bioreactor titers as well as demand for higher concentration final formulations. In some cases, these challenges may result in a reduction in facility run rate or process yield. Single pass tangential flow filtration (SPTFF) provides a simple and effective solution to overcome these challenges without requiring major changes to facilities or purification processes. This webinar reviews the advantages of SPTFF, discusses applications where SPTFF adds value, provides recommendations for process development, and presents guidance for scale up and implementation. By participating in this webinar, you will:
- Understand the basic principles of SPTFF
- Understand how SPTFF is used to overcome biopharmaceutical processing challenges
- Understand typical SPTFF process development and scale up objectives
Going Beyond The Batch: Benefitting From Continuous Thermal Viral Inactivation & Sterilization
Date: February 13, 2014
Time: 3:00pm-4:00pm (-5 GMT)
When used for viral inactivation, sterilization, or pasteurization of liquid biologicals such as media, pharmaceuticals, and nutraceuticals, Continuous Flow Thermal (CFT) Processing offers many crucial advantages over traditional processing. These can include:
- Lower Up-Fit Costs
- Reduced Production Times and Cost
- Higher And More Consistent Product Quality
- The Ability To Develop New Products
Optimizing a Continuous Wet Granulation Process by Understanding Granule Properties
Date: Wednesday, March 5, 2014
Time: 2:00 PM - 3:00 PM EST
In developing a continuous wet granulation process, it is easy to produce a large number of samples by varying both the formulation as well as the process parameters. Commonly used granule measurements include loss-on drying of residual moisture content, and particle size measurements from which correlations including the Carr Index and Hausner ration may be calculated. However, it is seen that these measurements are not sufficient to differentiate between a large number of samples produced at conditions which are not drastically different. Using a powder rheometer, we have been able to repeatably measure and produce reliable trends at multiple points in the process train (powder feeders, wet granules, dry granules) to determine which powder properties are critical-to-quality in generating the desired tablet properties. In this study two formulations were studied to demonstrate how to use improved understanding of granule properties to develop the design space of a continuous manufacturing process.
Emerging Market Capital Sourcing
Date: October 1, 2013
Time: 2:00pm-3:00pm (-5 GMT)
Speaker: Kevin Batche, Sr. Procurement Manager, IPS – Integrated Project Services
Evaluated from an operations standpoint rather than a technical standpoint, this webinar looks at common fears as they relate to sourcing process and packaging equipment from emerging markets. Of primary concern are the risks associated with material segregation, cross-contamination, test reports, qualification documentation, as well as parts and service after start-up.
- Benefits/Risks of emerging market capital sourcing as it relates to the execution of NA capital projects
- Learn how NA pharma owner initiatives and concerns have shaped the supplier qualification process
- Learn how the qualification process should be executed, results evaluated and the risk factor determined