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Drug Product Manufacturing

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Goals and Objectives

With the establishment of the new Manufacturing Science and Engineering section at AAPS, an annual two to three day themed conference devoted to various aspects of pharmaceutical /biotechnology manufacturing, packaging, engineering and quality is envisioned to be held every year. The conference in 2010 is the first in the series and will be focused on reviewing advances and opportunities in drug product manufacturing with a special focus on continuous manufacturing. While drug product manufacturing has been discussed in various workshops/conferences they have not focused on examples and practical applications of continuous manufacturing, advances in process control, and various approaches for managing risks to product quality throughout the product life cycle. On Day One, the meeting envisions providing a holistic perspective on continuous manufacturing in the pharmaceutical industry, which includes talks from academic, industry and regulatory bodies. The objective of Day Two is to provide an insight into some current approaches for quality risk management during manufacturing which includes adaptation of new techniques for process monitoring and product release as well as implementation of Continuous Verification throughout the product life cycle. Due to the vast field of manufacturing activity, this first conference will address only small molecule drug product manufacturing. A similar conference on biotech manufacturing will be the subject of a future MSE conference.

We hope that the attendees will also be able to:

  • gain knowledge about the continuous manufacturing process,
  • determine the advantages of continuous manufacturing and application of QbD and PAT concepts,
  • get a perspective on 'Real Time Release Testing' from companies who are well into such techniques and learn from regulatory bodies their experience of reviewing such applications,
  • gain insight into implementation of quality risk management strategies throughout the product life cycle, e.g. Continuous Verification.