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7 Challenges of Implementing Single-Use Systems in Biomanufacturing

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... Read More

Investment Trends In Single Use Systems

As the biopharmaceutical industry's focus moves from a blockbuster sales model to more targeted therapeutics, the need to avoid costly investments in sizable stainless steel equipment is increasing. The use of single-use bioprocessing equipment is making product manufacture increasingly efficient and frequently less costly, particularly for early... Read More

Behind the Scenes with Sanofi Pasteur: Extractables & Leachables Testing

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... Read More

Under the Microscope - Extractables and Leachables in Single Use Systems

With the release of the PDA Technical report 66 in mind, the adoption of single use systems has been again moved to the top of discussions in biomanufacturing and extractables and leachables is proving to be one of the major stumbling blocks. Pharma IQ have put extractables and leachables under the microscope using sources from Pharma IQ and... Read More

Hot Topics in Single Use Systems

In this eBook, we have gathered together content in a variety of formats: articles, interviews, videos and columns on the key topics in single use systems. Starting with industry overview articles, we build up to slightly more complex topics such as risk management and finally an interview with Alain Pralong, a speaker at the Disposable Solutions... Read More

Standardisation Forecasts

After gathering insights from various experts, we explore the various focal points connected to the standardisation movement and their potential influences on the market if the shift does come to... Read More

2017 Market Research: Disposable Solutions for Biomanufacturing

Single use systems in biomanufacturing can greatly simplify the path to market. This is due to the reduction of sterilisation time and spend, lowered labor efforts, swifter set up times, lower cross contamination levels and reduced operating costs in the production of pharma products. As a result, many are implementing more single use systems... Read More

Single Use Systems Industry Guidance: Activity Update

Unsurprisingly, it can be a challenge for the industry to keep pace with all of the industry bodies. and the best practices that they are putting forward. In response to this, Pharma IQ has created this snapshot guide to a selection of bodies active within the single-use-systems market to provide insight into their achievements over the past... Read More

White Papers

Standardisation within Single Use Systems- An Inevitability, But Does It Have To Be Painful?

A dominating focus for today’s single use systems in biomanufacturing is the road towards standardisation between equipment suppliers. The absence of standardisation between single use system suppliers is seen as a key discourager to end users despite the many advantages the format provides to the pharma and biotech production... Read More

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Trends and Success Factors in Disposable Technologies and Single Use Systems for Biomanufacturing

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... Read More

Disposable Solutions Implementation Infographic

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... Read More

If Single Use is Now the Norm

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... Read More

2017 Market Research: Disposable Solutions for Biomanufacturing

Single use systems, which are utilised within, can greatly simplify the path to market. This is due to the reduction of sterilisation time and spend, lowered labor efforts, swifter set up times, lower cross contamination levels and reduced operating costs in the production of pharma products. As a result, many are implementing more single use... Read More

Sponsorship Information

Disposable Solutions Business Development Pack

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... Read More

Presentations

PANEL: Addressing Compatibility Issues between Suppliers – will we ever see harmonisation?

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. Panelists:Stephen Brown... Read More

Single Use Flexible Antigen Facility Model : Operating a 100% disposable site

In case you missed out on Disposable Solutions 2016, download this presentation by Verhoeye Francis to see what was discussed.... Read More

Evaluation Strategy for the Introduction of Single Use Systems

Presented by Richard Chester at Disposable Solutions for Biomanufacturing 2016.... Read More

Closed Manufacturing Systems in Single Use Systems

Tony Hitchcock's presentation at Disposable Solutions for Biomanufacturing on closed manufacturing systems in single use systems.... Read More

Interviews

TRANSCRIPT: USP on Standards and Guidance for Single-Use Systems

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. ... Read More

Pfizer Animal Health: Disposable Solutions for Biomanufacturing

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... Read More

Podcasts

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... Read More

Implementing Single-Use Biomanufacturing Systems: What are the Challenges Ahead?

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... Read More

Desmond Hunt on Expectations for the New Chapter from the USP regarding Single-Use Systems

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.... Read More

New Territory: Extractables & Leachables in Disposable and Single-Use Manufacturing Systems

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... Read More

Infographics

INFOGRAPHIC: Overview of biomanufacturing activity and spend around the world

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... Read More

Whitepapers

Economic Analysis of Single Use Tangential Flow Filtration for Biopharmaceutical Applications

This article outlines an economic model for comparing the costs of reusable and single use TFF in biopharmaceutical applications. By Michael LaBreck, Global Product Manager for TangenX technology, and Mark Perreault, Director of Membrane Application Development for TangenX technology, both at... Read More

Articles

Single-use Disposables are Future Proofing Biopharmaceutical Manufacturing

Biopharmaceutical companies that get stuck with legacy technologies, including older stainless steel equipment, and older processes, end up watching as competitors transition to more efficient, cost-effective platforms. In this article Eric Langer breaks down the trends in the biomanufacturing industry and shows that the addition of single use... Read More

Video

Standardisation of Single Use: The Need for Consistency in Design

Ciaran Kelleher, Senior Engineer at Janssen Biologics explains the needs for the design of single-use components and how this is best achieved. He discusses  the challenges in Janssen and how they are overcoming these, including focussing on a smart concept porfolio of components instead of going from case-... Read More

Improve Communication between Suppliers and End-Users in the Disposables Biomanufacturing Industry

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... Read More

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Disposable Solutions for Biomanufacturing - Partnerships

To view the topics that will be discussed at 2017's iteration of Disposable Solutions for Biomanufacturing, please download the complete... Read More