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 process.
Under the Microscope - Extractables and Leachables in Single Use SystemsWith 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 elsewhere to look at the inhibitors and the guidance in this area.
Hot Topics in Single Use SystemsIn 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 for Biomanufacturing Conference.
7 Challenges of Implementing Single-Use Systems in BiomanufacturingIn 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.
Investment Trends In Single Use SystemsAs 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 stages such as R&D and clinical trials.
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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 testing.
Standardisation ForecastsAfter 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 fruition.
2017 Market Research: Disposable Solutions for BiomanufacturingSingle 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 within their production lines. Pharma IQ interviewed its network to pinpoint the specific trends in the industry and forecasts made by market players
Single Use Systems Industry Guidance: Activity UpdateUnsurprisingly, 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 year and potential updates to keep an eye out for.
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 Novasep.
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- by-case.
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 different suppliers and systems that they are using throughtout their processes.
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 wall!
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.
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 manufacturing.
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 up.
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.
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 commercialisation.
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.
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.
|Jerold Martin |
Chairman of the Board
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.
Evaluation Strategy for the Introduction of Single Use Systems
Presented by Richard Chester at Disposable Solutions for Biomanufacturing 2016.
Closed Manufacturing Systems in Single Use Systems
Tony Hitchcock's presentation at Disposable Solutions for Biomanufacturing on closed manufacturing systems in single use systems.
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 systems is adding flexibility.
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 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.
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 and, not least, the widespread adoption of single use technologies in development and manufacturing facilities for the production on antibody based products.
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 approaches.
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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 partners.