An ad hoc committee will develop and conduct an interactive, multidisciplinary, multisector public workshop that focuses on the current status of, and research opportunities for, continuous manufacturing in the pharmaceutical industry. The workshop will address biologics and upstream challenges of small molecules, with particular focus on synergies in manufacturing the two kinds of products. The 2-day workshop will:

1. Describe the current state of research and development for continuous manufacturing of pharmaceuticals, with an emphasis on 1) continuous bioprocessing (including control strategy) and 2) integrated upstream small molecule synthesis and purification (including control strategies such as process analytical technology, real time release testing strategies). Included will be a discussion of technical limitations and challenges that may prevent adoption of continuous manufacturing in the production of both small molecule and biological products.

2. Discuss innovative solutions and creative ideas for addressing these limitations and challenges, and highlight key areas that might benefit from technology investment or mitigation strategies to encourage and support broad adoption and rapid implementation of continuous manufacturing in the commercial sector.

3. Consider technical and programmatic lessons learned from continuous manufacturing of small molecule pharmaceuticals that may be applicable to biologics as well as newly identified challenges associated with biologics continuous processing. Discuss opportunities for collaboration across scientific/technical disciplines (nexus between biology/biochemistry and bio/chemical engineering), across sectors (academia/public vs. industry), including federal entities as appropriate, to accelerate the development and adoption of continuous manufacturing for biologic drug products.

4. Consider business challenges and regulatory hurdles that may impact the ability or the decision for industry to adopt continuous manufacturing processes.

Workshop participants will include representatives from academia, the pharmaceutical industry, U.S. government agencies, and professional organizations. The committee will plan and organize the workshop, select and invite speakers and discussants, and moderate the discussions. A workshop proceedings document will be prepared by a rapporteur, to describe workshop presentations, workshop discussions, and common themes that emerged in the context of the objectives. Findings, conclusions, and recommendations will not be included in the proceedings.