Presented by John Levesley
Across the biopharmaceutical industry, disposable technology is being used to produce antibiotics, vaccines, and antibody and protein-based therapeutics. Historically, a wide range of different types of disposables have been implemented, many of which are one-off designs developed by users or manufacturers in response to specific applications.
It has been identified that buffer and media preparation are common in the production of antibody and proteinbased therapeutics, antibiotics, and vaccines. So the Standard Disposables Design™ (SDD™) initiative has been initiated to concentrate on standardizing disposables for these applications.
In my presentation, I described that PM Group’s vision is to have most major biopharmaceutical companies store their media and buffers in the same design of disposable bags. Our mission is to facilitate the standardization between biopharmaceutical companies and suppliers.
There is an industrywide practice of buffer and media preparation in which end-users in production mix the liquids and then filter and transfer them to another disposable bag. In principle, that sounds simple to standardize, but it is complicated by the fact that tubing and filters can be different sizes and connectors can be specific to different suppliers. Within the same company, end-users often have a different way of setting up their media and buffer preparations. That can result in lengthy design times, a need for significant warehouse space to store disposables, and long lead times to set up a production facility. Significantly SDD™ will benefit end users because it will speed up delivery times, require less warehouse space, and produce like-forlike comparisons for multiple options. That means set-up time will be quicker, and the costs of disposables will be cheaper. SDD™ also benefits suppliers because they will have to maintain less inventory of different types of disposables. They will be able to massproduce standard assemblies, which can be sold through supplier websites.
To facilitate the use of SDD™, PM Group has created a database of about 350 assembly designs produced by multiple suppliers with SDD™ codes for end users. A list of current suppliers is included on PM Group’s website (www. pmgroup-global.com/Services/SDD. aspx), and additional suppliers will be added in due time. Assemblies for the SDD™ initiative were identified initially at a two- day workshop in 2014 hosted by the National Institute for Bioprocessing Research and Training (NIBRT) in Dublin. Representatives from 11 pharmaceutical companies and 16 suppliers discussed and decided upon the assemblies, including connectors, tubing length, and bag filters. Results of the NIBRT workshop were presented at the International Society for Pharmaceutical Engineering (ISPE) Conference in Washington, DC, in 2015. There are also ongoing meetings with and support from the Biophorum Operations Group (BPOG). Users can now view and order SDD™ parts from multiple suppliers online. The supplier websites being created will include lists of all SDD™ codes and their corresponding supplier codes. This will allow end users to click through to request price quotes. The websites also will provide detailed drawings, full bills of materials, and specifications for each SDD™ code.
Using SDD, end users can quickly download assembly drawings from the supplier website, sign and approve drawings, and have parts delivered in weeks rather than the four to six months this process usually requires.