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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10 | SEPTEMBER 1, 2018 | GENengnews.com Hélène Pora, Ph.D. Single-use (SU) technologies for com- mercial bioprocessing can provide sig- nificant benefits in terms of cost and time reduction, especially as modular approaches augment the landscape for new facility builds or existing facility updates. However, challenges to adop- tion remain to be addressed, which is why Pall Biotech has developed an advanced and comprehensive infor- mation management system to enable more efficient design, assembly, and implementation of SU systems and fa- cilities. Need to Address End-User Concerns Presterilized single-use systems can reduce setup and changeover times and eliminate the costs associated with cleaning and cleaning validation. These benefits have been demonstrated in the development setting and are increas- ingly being realized for clinical and commercial manufacturing, particular- ly in new hybrid and modular facility layouts that allow users to better opti- mize these system benefits. Concerns remain, however, regarding assurance of quality and compliance with GMP manufacturing across the supply chain and with the potential impact of ex- tractables on patient safety. There has been a shift to shared re- sponsibility for quality—and therefore risk—between the end user and suppli- er. Addressing these concerns requires close collaboration between SU suppli- ers and drug product manufacturers, with clear communication regarding the requirements and expectations of both parties. Suppliers must be able to dem- onstrate control of their supply chains and provide assurance that SU assem- blies and their components will not af- fect the drug product's quality. End users and suppliers through the BioPhorum Operations Group (BPOG) and the BioProcess Systems Alliance (BPSA) have worked together to devel- op the Single-Use Systems User Require- ments Specification (URS) Template, the Supply Chain Memo, and the Technical Diligence Document, which are tools designed to enhance communication. As a supplier, Pall Biotech has also committed to addressing end-user con- cerns about SU assemblies with the de- velopment of a proprietary Allegro™ Central Management System (ACMS). The dynamic information system sup- ports Pall's quality-by-design (QbD) approach to the development of SU as- semblies from the initiation of projects and throughout their design and imple- mentation. Birth of Pall ACMS Data on the first SU components to be commercialized was initially main- tained in Excel spreadsheets. This ap- proach was effective when Pall was assembling a limited number of SU systems from a limited number of com- ponents. Today, however, there are thousands of components available from many different subsuppliers, and process assemblies can consist of 50 or more of these components. Using spreadsheets is not practically scalable to this level of complexity. Users are looking for an advanced information management system for the storage and use of the expanding types and quantities of data related to SU components used to manufacture SU assemblies. Since no software pro- gram on the market met the needs, a Pall team developed the proprietary ACMS solution. The first module of the system was constructed to enable storage of all information pertaining to individual components and validation of compo- nent junctions. This module was then linked to a configurator, or drawing tool, so that designers could know if the joining of two components had already been tested and if tested junctions could be used. Test requests could also be ini- tiated if needed. Preferred Component Approach In the ACMS today, components used by Pall are classified into three categories: preferred, nonpreferred, Automating the Adoption of Single-Use Technology Single-Use Technologies for Bioprocessing Pall Biotech Describes the Benefits of Using an Advanced Information Management System

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