Listen to recordings of past webinars from INTERPHEX's 2012-2013 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.
Scale Up-Scale Out: Challenges in OSD Processing
Date: Friday, December 14, 2012
Time: 11:00 AM - 12:00 PM EST
In the current environment the pharmaceutical technologist is faced with an ever changing series of regulations, difficult drug substances and the time pressure to make market entry and reach maximum product potential quickly. For many drug substance candidates their inherent physicochemical and pharmacokinetic properties pose unique challenges necessitating application of advanced solid dosage form technologies. The same is true for innovators as well as generic firms that being the manufacture of bioavailable products which are seamlessly reviewed and reach the market quickly. Imbedded in this technical tapestry is the inevitable question of how large a batch needs to be or more fundamentally 'what scale do I need to achieve'. In many cases the need for scale-up and the effort to achieve this are looked at as a major technical challenge.
Led by industry experts, alternatives will be provided to this aspect by considering the risk in scale-up as opposed to the concept of scaling-out using a batch process which is more aligned with that of a 'pilot scale'. How to manage the perception that scale-up may be replaced with scale-out using more efficient processing scenarios that have an inherently lower degree of risk when looked at against the back drop of developing larger less flexible process scenarios. It is our objective to provide some insight when the question of 'what scale' is asked.
The webinar will touch on the following topics:
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Looking into the Crystal Ball: The Drivers and Attributes of the Biomanufacturing Facility of the Future
Date: Thursday, Nov. 1, 2012
A lot is being discussed and written about what biopharmaceutical manufacturing facilities of the future will look like, how they will operate, and what is driving companies to move outside their "comfort zone" to develop new design approaches and concepts. There are a number of approaches that are being discussed; some have varying approaches to address business and regulatory requirements.
Executives from Nanotherapeutics and Subject Matter Experts from IPS will provide their thoughts and vision on the impact of business climate, technology, regulatory philosophy, and operational approach in shaping the next generation facility model.
The webinar will touch on the following topics:
- Business drivers for current and new product platforms
- Emerging business models
- Enabling technologies
- Risk impact on process and facility design
- Process closure analysis
- Segregation impact on manufacturing environments
- Facility delivery models
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