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North America Technical Center of Excellence Opens

When French-based fragrance and flavors firm Gattefossé needed a new US-based cosmetics R&D Laboratory, they turned to DME to put together a team that would provide a full turnkey solution.  DME partnered with Johnsrud Architects and L.R. Constanzo Construction, both of whom were able to bring a deep resume of experience in laboratory design and construction.  Our history of working together provided to Gattefossé a seamless team of professionals dedicated to this important venture. The project involved renovation of a space adjacent to existing Gattefossé offices in a three-story flexible office building.  The laboratory includes Analytical, Emulsions, Pharma, Cosmetics and Make-up Color Labs. The Technical Center of Excellence brings together pharmaceutical and personal care application laboratories in a 5,300 sq. ft. space with state-of-the-art equipment.  The[...]

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The Balancing Act: Maintaining Aging Facilities vs. Facility Modernization

  The Balancing Act: Maintaining Aging Facilities vs. Facility Modernization As seen in by David M. Marks, President, DME Facility modernization can be a complex and difficult process even under the best of circumstances, but when one factors in the global regulatory hurdles in pharmaceutical manufacturing, the challenges are significantly greater. However, the reality of aging facilities that must be maintained in a state that is reliable, efficient, and compliant with current good manufacturing practice cannot be avoided. Successful implementation of change must be executed with a good understanding of the challenges associated with introducing new technology and an execution strategy that proactively achieves strategic outcomes. In an industry-wide survey of the life sciences sector conducted by DME in partnership with INTERPHEX, industry insiders—those in[...]

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DME Provides White Paper for Sterile Manufacturing Stakeholders

Advanced Aseptic Processing Manufacturing sterile products using aseptic processing is conceivably the most critical process in the pharmaceutical industry. Aseptic processing continues to see critical improvements, especially over the last several decades, and there are new approaches that are transforming traditional aseptic production methods. Hite Baker is a Principal Process Engineer with DME. He is a subject matter expert about sterile formulation, sterile filling lyophilization and barrier isolation.  He co-chair’s the Barrier Track for the ISPE Aseptic Conference.  He has authored a paper titled: Advanced Aseptic Processing.  In this paper, sterile manufacturer stakeholders will discover: Emerging technologies and regulatory guidance for implementing Advanced Aseptic Processing What the industry is saying about their challenges, priorities, and solutions in advanced aseptic technology adoption Considerations in choosing an engineering partner firm Click here for a free download[...]

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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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