PDA Letter Article

Multiverse of Manufacturing Challenges: A PDA Annual Meeting Session

by Walter Morris, PDA, Inc.

PDA Week is rapidly approaching. PDA Letter readers still might be wondering what exactly PDA Week is and what happened to the PDA Annual Meeting. Well, to put it simply, the cornerstone of PDA Week is the reimagined PDA Annual Meeting, with the following new features:

  • Facilitated roundtable discussions
  • Dedicated PDA concurrent session tracks
  • Training courses and mini-training courses throughout the week
  • Guided poster tours in the energy-filled Exhibit Hall
  • Site visit to Dendreon’s manufacturing facility
  • Tour of Takeda’s award-winning facility
  • Power walk
  • Group meditation
  • Group yoga
  • PDA Awards Dinner
  • Post-conference workshop

PDA Week takes place at the Long Beach Convention and Entertainment Center in sunny California, March 24 – 29.

As the PDA publications staff and contributors prepared our meeting experience, deciding which experts to invite for the On The Issue video and PDA Spotlight podcast recording sessions and to contribute articles to the PDA Letter and the PDA Journal of Pharmaceutical Science, I personally became intrigued by the topic of breakout session A1, “The Multiverse of Manufacturing Challenges,” because as long as I have been with PDA, manufacturing challenges always seem to be a hot topic. The session will be held on Monday, March 26, at 3:30 pm in room 101.

The session will delve into the ever-evolving challenges of biopharmaceutical manufacturing. The challenges in this multiverse range from incremental changes to significant leaps forward! The contemporary manufacturing operation must encompass the latest technologies and methods that create safe and cost-effective medicines that are also sustainable in a world increasingly demanding zero environmental footprints.

Session presenters will discuss the intricacies of manufacturing complex products, strategies to alleviate environmental burdens in production, and innovative solutions for formulation manufacturing. A1 is moderated by Sebastian Teitz, PhD, who wrote an article about the Annual Meeting earlier this month.

Ashley Harp, Process Engineer, CRB, opens the session with a discussion of the latest developments in antibody-drug conjugate manufacturing. Next, Ankur K. Shah, Lead Process Engineer, Arcadis-DPS Group, will blaze a path through the forest of sustainable manufacturing. Finally, Vaibhav Deokar, PhD, Principal Scientist, Lupin Limited, will look at challenges and solutions in the manufacture of ultra-high concentration antibody formulations from downstream to fill-finish processing.

The A Track of talks continues Tuesday at 10:30 am with discussions about the acceleration of manufacturing processes (A2), looking at the power of historical data, platform-based methodologies, and cutting-edge technologies. At 4:00 pm, session A3 explores the evolution of the biopharmaceutical industry. The A Track concludes Wednesday morning with A4 regarding an exploration of the toolbox needed for successful ATMP development through manufacturing.

While I have made my choice as to which Track I am planning to attend, I encourage you to visit the PDA Week website and find the sessions and talks that appeal to you.

About the Speakers

Ashley Harp is a Process Engineer with extensive experience in biopharmaceutical manufacturing. Harp's equipment experience includes purification skids, powder transfer and processing equipment, vessels, aseptic vial and syringe fillers, aseptic isolators, lyophilizers, hazardous compound containment, CIP, and SIP systems.

Ankur ShahAnkur K. Shah is a Lead Process Engineer at Arcadis-DPS Group with over 15 years of experience in facility design and construction. Shah's experience includes cell and gene therapy facilities and oligonucleotide-based therapeutics manufacturing facilities. Shah is an expert in executing scoping studies through construction in process engineering and project engineering roles. Shah has recently presented at ISPE FOF 2023, ISPE Aseptic 2023, and PDA Annual 2022 and has published a variety of articles. Shah holds a Master of Science in chemical and biomolecular engineering from the University of Pennsylvania and a Bachelor of Science in chemical engineering from the Indian Institute of Technology, Bombay, India.

Vaibhav Deokar, PhD, is the Principal Scientist at the Formulation Development Team of research and development, Lupin Limited (Biotech Division), India. Deokar has pursued his Master of Technology (Bioprocess Technology) from the Institute of Chemical Technology (ICT) (formerly UDCT), Mumbai, and has completed his PhD under the Lupin-Manipal ASCENT PhD program. Deokar has authored research articles in peer-reviewed journals and is a key contributor to more than six formulation patents for biopharmaceuticals. Deokar has 14+ years of experience in developing formulations for complex biopharmaceuticals like peptides, fusion proteins, and monoclonal antibodies. Deokar is responsible for fill-finish process development, characterization, and technology transfer within Lupin and other drug product manufacturing facilities. Deokar has faced regulatory agencies for formulation and fill-finish process development-related queries. Deokar has special interests in new product development, product differentiation, and enhancement strategies and provides new differentiation strategies for a couple of products in the pipeline.