Implementation Strategies and Challenges for Single-Use Technologies at Commercial Scale


17th May 2018 | 10AM PT | Adam Goldstein, Roche/Genentech and Jacob McNeil, Thermo Fisher Scientific |WATCH FOR FREE

For over 10 years, single-use technology (SUT) has been a growing buzzword in the biomanufacturing industry for its advantages in speed, flexibility, and cost. A recent 2015 BioPlan Associates, Inc. industry survey of biopharmaceutical manufacturers, contract manufacturing organizations, industry vendors, and direct material suppliers identified the ‘Top Concerns’ for why biopharmaceutical manufacturers are choosing to increase their use of disposables. The top three reasons were (i) Eliminates cleaning requirements, (ii) Reduces time to get facility up and running, and (iii) Reduces capital investment in facility & equipment. These reasons are no surprise, as elimination of steam in place (SIP) and clean in place (CIP) allows for a reduction of required piping and controls, which in turn significantly decreases capital costs, design engineering, and field installation times.

While these are some of SUT’s core drivers, their validity among that of many additional drivers have already been analyzed and proven at length. Perhaps the more interesting reasons for the continued focus on SUT are the growing industry trends towards modular flexible facilities and lean manufacturing.

In order to adapt towards more targeted therapies for niche populations, biopharmaceutical manufacturers will need to produce multiple high potency products, with greater changeovers, and at smaller batch sizes.4 By significantly reducing capital outlay, disposable modular facilities allow for both product and geographical manufacturing flexibility. Production is thus enabled at a lowered associated risk wherever assets are best utilized and production costs minimized, such as in emergent markets.

With new cell and gene therapies, retiring legacy product patents, and rising biosimilars, there is also continued pressure to maintain affordable, consistent, and quality products.5 Companies that remain competitive will be those who can commit to realizing lean, agile, and efficient manufacturing.

While single-use is well aligned with these growing industry focus areas, there is also no doubt that SUT’s complexities and nuances can hinder its smooth implementation. As single-use plastics are more delicate and variable than stainless steel, a majority of these complexities originate with the material of construction itself – in qualification, handling, and network standardization. A clear global SUT strategy that addresses these complexities should be founded in the overall coordination, management, and harmonization of SUT practices across company sites. This a webinar will discuss some of those key challenges, and provide corresponding risk mitigation strategies and considerations for successful, agile SUT implementation.

 

Presented by Adam Goldstein, Roche/Genentech

Adam Goldstein is currently the Roche/Genentech global lead for Single Use Technologies. His current function is to lead and develop strategies for single use technologies and aid in the tech transfer of new molecules and process engineering changes with in the manufacturing sciences areas for development and commercial operations.

In recent years Adam has been the start up lead for both Clinical and Commercial operations- leadership for some of the largest commercial manufacturing facilities in the US.

5 Significant Biotech Facility Start ups including Genentech, Amgen, Biogen, Baxter, GenVec facilities.

 

Sponsored by ThermoFisher Scientific

 

Presented by Jacob McNeil, Thermo Fisher Scientific

Mr. Jacob McNeil currently serves as Senior Manager Integrated Solutions, Single Use Technologies at Thermo Fisher Scientific in Logan, Utah. He has a Biologics background and has spent the last 19 years in this Industry in various roles such as Operations management setting up Single use manufacturing sites, Business Market Development for customer facility expansion project, Senior Product Manager of New Product Development, and currently manages a team of project Managers and engineers for customer equipment projects which includes Cell Culture Bioreactors, Bacteria Fermentors, Mixers, and Controls.


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