BioPharm June eBook: Single-Use Systems

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Page 29 of 46 June 2018 BioPharm International eBook 29 Single-Use Systems Quality Drug product manufacturers are working on initiatives to standard- ize or harmonize on preferred and pre-qualified single-use compo- nents. This includes components that already have well-characterized chemical compatibility and extract- ables profiles and have been used in other biopharmaceutical processes before. Many of the large biophar- maceutical companies have begun developing their own internal cata- logs or libraries of components and are requiring that all new single- use system designs be created using the pre-defined library of compo- nents. This significantly cuts down on the amount of time and cost spent on testing and qualification of new components and helps drive harmonization of single-use system designs. Pora (Pall Biotech): As a company, Pall Biotech has been work ing diligently to gather the E&L data needed to support customers and help advance industry understand- ing of the importance of these crite- ria. And as we design new products, or create the next generation of existing products, we place a great deal of importance on controlling materials of construction. At the end of the day, nothing will save the supplier from having to generate data that can help end users qualify the systems they are either currently implementing or are interested in implementing. QUALIFYING VENDOR DATA BioPharm: How are vendor data qualified? Bulpin (MilliporeSigma): The biggest change when moving from stain- less-steel processing to single-use is the shift in ownership of critical qualification strategies and activi- ties. Things such as equipment cleanliness, sterility, and integ- rity, which were once defined and owned by the drug manufacturer, are now owned by the single-use supplier. Due to this shift, it's important for the drug manufac- turer to verify any data or qualifica- tions received and/or performed by the single-use supplier. Partnership and collaboration between the drug manufacturer and single-use sup- plier are critical when it comes to qualification of vendor data. D r ug m a nu f ac t u r e r s shou ld audit their single-use supplier to review procedures, protocols, test methods, and reports related to testing and qualification activi- ties. In addition to a vendor audit, vender data can be qualified by performing independent testing and comparing the results with the vendor's provided data, or through performance testing. Hower and Lu (SGS): Due to the requirement for extractable and leachable testing by the regula- tory bodies, many vendors per- form the characterization of their own single-use systems following the general principles detailed in BPOG Standardized Ext ractables Protocols published in 2014 (9) and USP drafted Chapters <665> and <1665> (4,5). As the vendors are attempting to provide some gen- eral information about their prod- ucts, the characterization process lacks the specificity and detail that a comprehensive extractable profile should contain. In the case of lower risk components, the vendor's data may be used as a way to qualify the manufacturing components, but in the case of components assessed as a higher risk, a specific extract- able and leachable study design tak- ing into consideration the product formulation and dosing regimen should be considered. BPSA: It is perhaps more impor- tant to consider how any data are qualified or judged suitable for eval- uation of single-use systems. The single-use industry, with leadership from BPSA, is making an effort to align on definition of critical attri- butes for single-use systems, on methods of determining values for those attributes, and on methods of reporting the data. Standard analytical methods for attributes such as extractables, particle con- tamination, and system integrity will support further expansions of single-use systems in biomanufac- turing. Vendor (supplier) data are qualified as a part of the overall supplier quality assessment by end users. End users are able to determine the quality of work done by a pro- spective supplier by reviewing vali- dation guides and observing testing during site visits. Testing should be performed using accepted labo- ratory practices and by following standard procedures where avail- able. Provided that the supplier can demonstrate control of their testing program, the data are frequently used without additional confirma- tory or supplemental testing by the end user. REFERENCES 1. 21 CFR 211.65 2. USP, <232> Elemental Impurities— Limits, USP 40 –NF 35, First Supplement, Official December 1, 2017 3. ICH, Q3D Guideline for Elemental Impurities (ICH, December 2014 4. USP, <665> Polymeric Components and Systems Used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products, Pharmacopeial Forum (PF) 43 (3) (USP, 2017). 5. USP, <1665> Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products, Pharmacopeial Forum 43 (3) (USP, 2017). 6. USP, <661.1>Plastic Packaging Systems and Their Materials of Construction, USP, May 1, 2017. 7. EDQM, European Pharmacopoeia 3.1.X series. 8. EMA, Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use' (SANTE-2017-11668) (EMA, Oct. 9, 2017). 9. BioPhorum Operations Group (BPOG) Standardized Extractables Protocols (BPOG, 2014). BP

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