Genetic Engineering & Biotechnology News

NOV1 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Page 49 of 57

12 | SEPTEMBER 1, 2018 | be suitable for a new project. In this way, it efficiently leverages experience to facilitate the design process, further reducing project timelines. Standardized Extractables Data The ACMS houses all the standard- ized extractables data that Pall has been generating since 2015 using the BPOG pro- tocols. The extractables testing program has two facets: a retrospective effort and a proac- tive effort. We began testing existing compo- nents with a focus on the most widely used and representative products. At the same time, we began testing all new products prior to launch. Testing begins with screening using high- resolution mass spectrometry to gain an in- depth understanding of the material compo- sition. Extractables testing is then conducted and a technical report generated according to the BPOG guidelines. Data, including a descriptive summary (with major results, ex- traction parameters, and analytical and quan- tification methods) and detailed results for all compounds observed, is captured in the ACMS system. Results for elemental impurities analy- ses conducted according to the ICH Q3D guideline and Pall's own methods are also included in the ACMS database. Furthermore, Pall is strongly encourag- ing suppliers of non-Pall components to pro- vide information on extractables, specifical- ly, data on elemental impurities. Information that is provided is extensively reviewed and, once approved, captured in the ACMS. Encompassing All Aspects of SU Assemblies The ACMS facilitates all steps of SU as- sembly projects, from initial inquiry to pro- cess design, technical review, manufacturing approval, customer acceptance, and ulti- mately product manufacture (Figure). The web-based system houses all component in- formation in one location, preventing data duplication and ensuring that information is always up to date. By encouraging the use of preferred com- ponents and ensuring that all designs meet end-user specifications and validation re- quirements before they are submitted for approval, the system helps reduce lead times and provides enhanced reliability and ro- bustness. The advanced searching function- ality also assists customers in their rational- ization efforts. Dynamic Solution By applying a QbD approach to SU as- sembly design and production from the start, users can accelerate access to high-quality, fit- for-purpose, single-use systems with strong documentation packages. The ability to re- cord and search all data on SU components, junctions, and assemblies in one live system combined with a formal approval process helps to shorten timelines for the design of SU assemblies that are fit for purpose and of consistent quality, while also optimizing reli- ability and security of supply. The system is not a static solution—data and information management needs change as business practices and requirements evolve. As such, a dedicated team is working to fur- ther develop the ACMS system and update it through time. A roadmap is also in place for adding further functionalities to this valuable, dynamic tool. Hélène Pora, Ph.D., is vice president, technical communication and regulatory strategy, Pall Biotech. Website: Automating the Adoption of Single-Use Technology Continued from page 11 Single-Use Technologies for Bioprocessing Figure. Single-use (SU) technology suppliers and end users are increasingly sharing responsibility for quality assurance and compliance with industry standards. In its collaborations with end users, Pall Biotech supports a quality-by-design approach that facilitates all steps of SU assembly projects. The approach is enabled by Pall Biotech's Allegro™ Central Management System (ACMS).

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