At INTERPHEX 2016, David Marks, President of DME, was a panelist as part of INTERPHEX Live. The subject was Overcoming Facility Upgrade Challenges. The video of the discussion has been made available and posted here on our website.
by David M. Marks, P.E., President Programming GMP facilities has always been a challenging endeavor. Market uncertainties, limited process definition, and stringent regulatory requirements typically complicate the task. Too often, manufacturers end up with facilities that are underutilized or over capacity from day one. McKinsey & Company identifies Rightsizing Capacity and Greater Flexibility as two of the leading trends shaping the landscape of biopharma manufacturing today. These are really two sides of the same coin, as both elements have a direct impact on facility utilization and total cost of goods sold. Generally, facilities that are more flexible tend to be better utilized. But what kind of flexibility is most useful to achieve this utilization? And how can we ensure that future[...]
by David M. Marks, P.E., President The agent most frequently cited as enabling facility flexibility in the biopharmaceutical marketplace is disposables, or single use technology (SUT). This is because SUT conveniently allows manufacturers to outsource one of the most difficult aspects of multi-product bioprocessing – achieving process closure that fully segregates the product from potential sources of contamination, including cross-contamination from other products. In so doing, it helps to realize the potential for licensed facilities to manufacture multiple GMP regulated products – a much more flexible paradigm. SUT also significantly reduces the time required for product changeover, effectively expanding plant utilization. Finally, SUT provides a tool for reducing the cost and complexity of facilities required for biopharmaceutical manufacturing. When applied comprehensively,[...]