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[...]
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[...]