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In this benchmarking survey report Pharma IQ draws comparisons with previous survey conducted at the end of 2013. Find out what has changed in the industry, what to consider when choosing new suppliers, best way to tackle extactables & leachables and we compare different investment approaches.
In this interview Jerold Martin, Sr. Vice President, Global Scientific Affairs for Pall Life Sciences and Chairman of the Bio-Process Systems Alliance (BPSA), speaks about the aims of the PDA Technical Report Number 66, Application of Single Use Systems in Pharmaceutical Manufacturing and what progress has been made with standardising practices for disposables in biomanufacturing. Plus, he highlights seven challenges the industry will face in 2015 during the implementation of single-use systems.
Pharma IQ spoke to Ken Wong - MTech/Process Technology - Extractables & Leachables Sanofi Pasteur, who has been leading the site’s E&L programme since he joined just over two years ago, to explore Ken’s real world projects at the pharma firm in regards to extractables and leachables testing.
This panel brings together two leading industry experts to address the challenges of integration between different vendor technologies and how to asses compatibility. Flexibility and the ability to work with multiple suppliers is a crucial factor in the decision to switch to single use and how and when to implement.
Chairman of the Board
Eight Minutes to Best Practice on Effective Implementation & Integration of Disposables (Single-Use) Systems
Disposables (Single-Use) systems have been widely established in pharmaceutical and biotechnology companies’ biomanufacturing processes across Europe and the US with proven economic and fast product changeover benefits. Tony Hitchcock, Head of Manufacturing Technologies at Cobra Biologics explains best practices on implementation and integration of multi-component disposable systems, maximising economic benefits and utilising new biomanufacturing models.
Jay Thompson, Associate Director of Bioprocess Development at Pfizer Animal Health, discusses the impact of the slow implementation of disposables for downstream processing and how Pfizer is getting around quality and regulatory challenges as they move towards commercialisation.
Pharma IQ has created an easy-to-digest overview of biomanufacturing activity and spend around the world, whether they are already being implemented or have plans in the near future. You’ll be able to keep it as a handy reference, share it around your colleagues or even stick it on your wall!
Learn more about what business objectives you can achieve by attending the Disposable Solutions for Biomanufacturing Summit via our brand new BD pack. It includes a previous audience breakdown (eniority, geo and industry), list of solutions and platforms we offer, and testimonials and support from previous partners.
One of the biggest challenges in the Disposables area is communictaion between end-users and suppliers around the area of leachables and reaching a common consensus on the standardisation of products. Dan Nelson, Marketing Manager at Thermo Scientific looks at what can be done to improve interconnectivity and the functionality between the different suppliers and systems that they are using throughtout their processes.
In this exclusive interview Alain Pralong, VP New Product Introduction and Technical Life Cycle Management at GlaxoSmithKline Vaccines, speaks about the challenges faced evaluating single-use systems for extractables and leachables and implementing single-use technology in biopharmaceutical manufacturing.
The adoption of disposable solutions in biopharmaceutical manufacturing is a global trend. Asia is no exception and in recent years single use technology has become increasingly prevalent in the region’s biopharmaceutical manufacturing industry, but with this rapid growth there is a need to bridge a gap between new technology and its implementation. The results of this survey compiled here reveal the level of adoption for disposable solutions, the level of investment, attitudes towards suppliers as well as the challenges being faced in adoption.
In this exclusive Pharma IQ interview Desmond Hunt, Senior Scientific Liaison, United States Pharmacopoeia (USP), speaks to Andrea Charles from Pharma IQ, about the current standards and guidance for single-use systems and the expectations for the new chapter from the USP regarding single-use systems.
One of the most significant challenges facing the Bio-Pharm industry in recent years has been how to reduce development timelines and cost; billions of dollars have been invested in this area, with significant success. This has included the adoption of high throughput screening technologies, rapid single stage scale up of manufacturing process and, not least, the widespread adoption of single use technologies in development and manufacturing facilities for the production on antibody based products.
In this Pharma IQ interview Tony Hitchcock, Technical Director at Cobra Biologics, speaks to Andrea Charles from Pharma IQ, about why single use systems are not implemented more commonly across the biomanufacturing industry and the challenges surrounding scale up.
Desmond Hunt, Senior Scientific Liaison, United States Pharmacopoeia (USP), discusses the current standards and guidance for single-use systems and the expectations for the new chapter from the USP regarding single-use systems. Hunt also shares his insights on challenges for extractables and leachables.
In this Case Study from Disposables 2018, Lars Hovmand-Lyster, Senior Engineering specialist, Global Project Office at Novo Nordisk takes us through “A risk based approach to operating closed systems in CNC Ballroom”.
Download this presentation to:
- Discover how utilising a risk based approach to assessing appropriate room classification for non sterile API production can increase product quality whilst minimizing the chances of contamination and unforeseen adverse manufacturing outcomes
- Examine how a shift in manufacturing approach and an incorporation of risk based analysis can reduce ongoing operational costs
- Learn how to increase the flexibility and reactivity of facility operation and capacity