BioPharm June eBook: Single-Use Systems

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Single-Use Systems Qualification June 2018 BioPharm International eBook 23 Isberg (Entegris): For the most part, change is managed by the single-use system suppliers, with no understanding of the criticality of the change to the end users' pro- cess. Because of this, the change notification often has incomplete or missing information. This can also lead to large numbers of noti- fications which can be difficult for end users to manage. Joint work currently being performed by the BPOG and BPSA organizations is moving the industry to a standard change management and commu- nication process where both sup- pliers and end users work together to manage change. Pora (Pall Biotech): As with all sys- tems, change is managed via docu- mentation and generation of data. As an industry, we still have a lot of work to do to create standard guidance, hence the importance of industry associations such as BPOG and the Bio-Process Systems Alliance. By partnering in these efforts, there can be more rapid progress in the guidance related to c ha nge cont rol, t houg h, it does not change the fact that this remains a heav y burden on the industry. B P SA : T he pa rad ig m sh i f t to polymer-based bioprocessing sys- tems (vis-à-vis steel) has engen- dered a need to document change control methodologies. Plastics are relatively complex materials, e ng i ne e re d for t he i r i nte nde d use. I n t he case of si ngle -use systems, the supply chain is not comparable to steel. Single-use system components are derived from medical grade resin (from hydrocarbons) then compounded, e x t r ude d a nd /or molde d, a nd finally assembled into integrated 'bioreactors' to yield a 'fail-safe' r isk-averse manufact ur ing plat- form for drug products. In any one single-use system, inclusive of t he bags, mu lt iple poly mers such as polyethylenes, polycar- bonates, silicones, and thermo - plastic elastomers (TPEs) may be present. REFERENCES 1. BPSA, Consensus Quality Agreement Template for Single-Use Biopharmaceutical Manufacturing Products (BPSA 2014). 2. USP, <665> Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products, Pharmacopeial Forum 43 (3) (USP, 2017). 3. USP, <1665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products, Pharmacopeial Forum 43 (3) (USP, 2017). 4. BPOG/BPSA proposal: An Industry Proposal for Change Notification Practices for Single-Use. Biomanufacturing Systems (May 2017). 5. ICH, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (ICH, November 2017). BP Call for Papers * Call for Papers * Call for Papers BioPharm International integrates the science and business of biopharmaceutical development and manufacturing. We provide practical, peer-reviewed technical solutions to enable biopharmaceutical professionals to perform their jobs more effectively. We are currently seeking novel research articles for our peer-reviewed journal as well as manuscripts for our special issues. Submitted manuscripts should be sufficiently novel to be of interest to an experienced audience. Articles should be data driven and provide sufficient technical detail to support the main thesis or should offer a novel synthesis of existing data. Topics should be timely and useful and should focus on the development of peptides, monoclonal anti- bodies, fusion proteins, other therapeutic proteins, nucleic acids, vaccines, cells for cell therapy, and any other class of biotechnologically generated molecular class. For peer-reviewed papers, members of BioPharm International's Editorial Advisory Board and other industry experts review manuscripts on technical and regulatory topics. The review process is double-blind. Manuscripts are reviewed on a rolling basis. BioPharm International readers are involved in product and process development, manufacturing, quality control/qual- ity assurance, analytical technologies, regulatory affairs, plant and project engineering and design, and corporate man- agement for the entire scope of biopharmaceutical products, including therapeutic peptides, proteins, nucleic acids, and cells for cell therapies and regenerative medicine, as well as both therapeutic and prophylactic vaccines. Please visit our website,, to view our full Author Guidelines. Manuscripts may be sent to Editorial Director Rita Peters at WWW.BIOPHARMINTERNATIONAL.COM

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