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Single-use Technology – Evaluation and Suitability and Process Economy in Biopharmaceutical Manufacturing

上市日期:2017-09-21
浏览次数: 7

 

Since the introduction of disposables and gaining popularity of Single-use Technology (SUT) for biopharmaceutical manufacturing there is nevertheless an ongoing controversial discussion on the advantages and disadvantages versus a conventional stainless steel environment.

Once the concept for the general operation of the facility in question has been established, the selection and choice of equipment has to be made, their footprint will define the required space, and most likely and preferably they are based on the intended manufacturing process(es) : How much and to what detail is the intended process defined? Which volumes need to be handled? How many tanks / containers of which volume are required?

What scale of equipment to choose? This may illustrate that in spite of process economy and commercial profit a suitable development and design of a manufacturing process can only be as good as the management forecast for the product’s market. After all, a tailored process design is finally decisive for the overall commercial production economy.

 

The “flexible” approach using disposables and single-use equipment can offer significant advantages regarding changeover work and time thus a high throughput of different processes will definitely take profit as any cleaning and related validation and costly analytics doesn’t apply to a larger extent. Despite the potential benefits loudly advertised by the respective industry, these potential advantages derived from single-use equipment and disposables can be significantly diminished by lack of detailed process cost analysis, missing economic analysis and cost comparison between conventional and SU technologies as well as underestimating the cost of long term dependency on consumables. Due to missing appropriate standards, there is a widely non-compatibility between the equipment and consumables of the various suppliers, resulting in a strong dependence on the consumables of a single supplier once a single-use equipment has been purchased, curiously leaving some customers with surprise that they hardly have any room for price negotiations on the required consumables.

 

“The China Biomanufacturing Single Use Conference 2017”to be held on the 26th-27th in Oct. Shanghai has invited Dr.Joachim Walter from Walter Biotech Consultancy to discuss the evaluation and suitability and process economy of single use technology in biopharmaceutical manufacturing. Dr. Walter’s presentation will focus on the very different arguments for the application of SU equipment and consumables, including advantages and limitations of SUT, understanding improvement of process robustness, contribution to lean production as well as environmental impact of disposables. In addition, Ms. Vicky Xia the Project Director from BioPlan Associates, Inc.will present on the topic of 10-Year Trends in Global Single-use Technologies, and SUS Adoption by China’s Rapidly Growing Biopharma Industry; Mr. Jason Li, the Vice President Genor Biopharma/Walvas Biotechnology will discuss the Development and Application Trends of One Single Use Technology in  the Downstream Process of Biopharmaceutical industry; and Mr. Wei Kang, the Senior Process Specialist of NNE will talk about the engineering design for biologics facility with global practice.

 

 

“The China Biomanufacturing Single Use Conference 2017 (BSUT2017)” will gather 200+ worldwide leading biopharmaceutical companies, biotechnology companies, CDMOs/CMOs; Single use solution providers, Materials suppliers, Associations and Regulators etc. to address standards and guidance protocols that address the use of disposable products and single use systems in biomanufacturing; Single use system verification requirements and localized verification services; the process and patient safety issues associated with leachables and extractables; Discuss the interoperability of Single Use System; How to Control the Risk in the Supply Chain etc. industry hot issues, to help you Identify the right strategy for implementing disposable products and single use systems; buildup profitable and sustainable business partnership and achieve success in 2017 and beyond!

 

For more information and registration about this conference please contact:

 

Mr. Klaus Qian  021-52710299*8002; Klaus.qian@grccinc.com

http://www.biomanufacturingsingleuseconference.com/

 


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