PDA Letter Article

PDA’s Critical Role in Advancing Manufacturing Science

by Mary Oates, Emergent BioSolutions

Mary Oates

PDA has long been a leader in advancing pharmaceutical manufacturing science, including the areas of process understanding, technology implementation, risk-based thinking and decision making, knowledge transfer, and the pragmatic execution of operations.

Collaboration with many stakeholders, including our members, the broader pharmaceutical industry and global regulators, has resulted in decades of technical reports, publications, articles, conferences, workshops, meetings, training and educational programs. From its first technical report on moist heat sterilization to publications, meetings, and training on process validation, drug shortages, quality risk management, aseptic processing, filtration, process robustness, blow fill seal technology, manufacturing equipment and systems lifecycle management, PDA has played a critical role in developing and disseminating information necessary for manufacturing professionals in our industry.

In fact, as we consider a list of PDA meetings, publications, and training, it is hard to name any which do not benefit manufacturing.

Several years ago, to reinforce PDA’s focus on and commitment to manufacturing, a Manufacturing Science and Operations Program (MSOP) was initiated. MSOP recommends topics and actions to respective PDA technical advisory boards, as well as planning committees and education teams, serving as a dynamic facilitator of PDA’s manufacturing science focus.

Through the commitment of PDA’s members, enabled by collaboration across the technical advisory boards, MSOP and stakeholders from all sectors of the pharmaceutical industry, we continue to build on our legacy of advancing manufacturing excellence. A few of the many examples of value delivered by PDA for manufacturing practitioners over the past few years are outlined below:

  • Points to Consider for Aseptic Processing Parts 1 and 2, published in 2015 and 2016, incorporated input from membership and the industry at large on understanding and successfully implementing aseptic processing controls that are the most challenging or perplexing for industry.
  • Points to Consider for Aging Facilities was published in 2017 as part of an ongoing focus on manufacturing improvements. It reflects the general thoughts and suggestions of the pharmaceutical manufacturing industry on how to identify and modernize aging facilities and covers critical elements including Recognizing an Aging Facility; Impediments to Modernization; Business Case for Modernization; Impact of Changing Standards; Slowing the Aging.
  • PDA and the Biophorum Operations Group began a collaborative effort in December 2017 to address industry and regulatory concerns related to pre-use, post-sterilization integrity testing (more commonly referred to as “PUPSIT”) of sterilizing grade filters used in aseptically processed biopharmaceutical products. The consortium was formed as a result of inspector-derived concerns that PUPSIT was needed to detect non-integral filters before they are used to eliminate any risk of not detecting them after the filtration process has been completed. The work, which concluded in December 2020, included ground-breaking research studies and resulted in the publication of multiple papers. In summary, the use of risk-based assessments to determine what controls are needed to mitigate and prevent filter-related risks, which take into account available scientific evidence, were recommended.
  • Points To Consider For The Aseptic Processing Of Sterile Pharmaceutical Products In Isolators, published in 2020, focuses on important regulatory and technology updates impacting isolator design, validation, and operations for aseptic processing.
  • PDA continues to offer its two-week, flagship course on aseptic processing, as it has since 2007.

Topics that are currently being evaluated for further focus by PDA include those that will address both the challenges and opportunities arising from the past few years, including the need for greater agility in manufacturing which can be accomplished through operational excellence, streamlined processes, reduced post-approval change burden and standardized manufacturing systems. PDA is also interested in the use of standardized and modular manufacturing PODs and platforms, further and more effective use of operational intelligence, better ways to monitor and control manufacturing systems and continued process manufacturing, among others.

Ultimately, PDA exists to fulfill our mission, which is “to advance pharmaceutical/biopharmaceutical manufacturing science and regulation so members can better serve patients.” Excellence in all aspects of pharmaceutical manufacturing is critical for our industry to serve patients and PDA remains firmly committed to being a leader in delivering significant value in this important area.

We are always seeking volunteers who are interested in joining us as we continue to build on the PDA legacy of advancing pharmaceutical manufacturing excellence. If you are interested, please contact [email protected].