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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. lang: en_US Tweet

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Biopharmaceutical Facilities: What Kind of Flexibility do you Need?

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[1]. 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[...]

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Realizing the Benefits of Single Use Tech in Facilities of the 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,[...]

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Hite Baker, DME Process Engineer Quoted in BioPharm International

Parenteral Advisory: Outmoded Fill/Finish Technology Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products? September 1, 2016 By Randi Hernandez BioPharm International (Hite Baker, Principal Process Engineer at DME was recently quoted in the BioPharm International article, “Parenteral Advisory:Outmoded Fill/Finish Technology”. Below is an excerpt from the article. To view the full article and to read Hite’s thoughts on the future of aseptic manufacturing, click here.) The demand for fill/finish services has significantly increased in recent years, according to Peter Pekos, president and CEO at contract manufacturing organization (CMO) Dalton Pharma Services, and many companies have expanded capacity to meet that demand. Don Paul Kovarcik, technical marketing specialist from CMO Ajinomoto Althea, Inc.,[...]

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Managing Projects in Legacy Facilities: Aligning Objectives for Successful Outcomes

by David M. Marks, P.E., President Most industry insiders recognize that there are two types of objectives associated with renovating legacy manufacturing facilities: opportunity-based and risk-based. Those that are opportunity-based seek to create a business advantage through improvements in capacity, quality or efficiency. These are the fun projects; however, they sometimes don’t come to fruition because they fall victim to the tyranny of the urgent. Objectives that attempt to mitigate risk are motivated by loss aversion. These are often the high profile remediation efforts that jump to the fast track after an accident, loss, or regulatory observation. In my experience with facility designs executed by DME, most renovations are not purely opportunistic or risk-driven. Rather, they typically have a combination of opportunity and risk-based[...]

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