By Timothy Tyson, Aptuit, Inc.
Unprecedented financial challenges and scientific opportunities are inspiring revolutionary change in the pharma industry’s approach to manufacturing. Through adoption of best practices drawn from other industries, the pharma industry could conservatively reduce the average COGS (cost of goods sold) by 20%, or $40 billion, per year.
In parallel with the intensifying need to reduce costs, we’re experiencing an explosion in our understanding of genomics, proteomics, and disease subtypes, all of which are creating new opportunities for drug developers. Layer upon this the pursuit of companion diagnostics and combination therapies, and traditional manufacturing processes, technologies, and facilities are stretched to their limits.
Manufacturing systems must be able to deliver the more diverse and challenging types of products being developed. The technology and skill sets needed to manufacture these novel therapies are becoming more complex, requiring significant investment at a time when the industry is experiencing overcapacity and excessive cost. Current capacity utilization in the industry ranges, at best, from 30% to 40%.
The need to improve flexibility and increase productivity and efficiency, all while reducing overall operating costs, will require drastic changes in the “pharmaceutical facility of the future.”
Agility And Flexibility
Drug manufacturing must become more agile and responsive, and drug manufacturers are demonstrating a willingness to relearn established ways of doing things. Manufacturing plants of the future will be increasingly more flexible, with production lines that respond quickly as opportunities arise. The use of portable and single-use, disposable equipment will be added or moved to wherever the need is and will be automatically incorporated into a wireless network and configured in the control system for batches to be produced. Integrated sensors will continuously monitor performance and quality parameters of each process on a real-time basis, thereby insuring product quality and generating data needed to optimize production. Simulation and data analysis tools will accelerate the transfer from development to full-scale manufacturing.
Lean manufacturing will become common practice. Quicker response times in accordance with market demands will require less warehouse stock. As patient treatments become increasingly individualized, greater flexibility in the definition and size of a batch will be required. Some therapies will be made to order rather than made to forecast.
Manufacturing plants will increasingly utilize modular building strategies. Facilities will include disposable process equipment, enclosed clean rooms around process equipment, and lean design concepts. This approach provides significant cost savings and reduces start-up time frames for new facilities.
Designing outcomes into manufacturing processes via quality-by-design concepts will be critical to reducing costs, increasing efficiencies, and assuring regulatory compliance. Flexible facility design will contribute to reduced financial risk as products progress from Phase 1 to Phase 3. Traditional approaches require investment of millions of dollars into a facility for a product to be manufactured in the hope that the candidate will succeed in Phase 3 testing.
While agile and adaptable facility designs will become more widespread, dedicated manufacturing facilities will still be required under certain conditions, including large-volume products with high API and/or drug product demands, manufacture of highly potent or toxic drug substances, and the need for specialized processes.
Increasing amounts of data will be generated and must be collected, integrated, made available and understandable, and preserved to meet regulatory and process improvement needs. Improvements to systems that manage data will be required to ensure patient safety, product quality, and cost containment. Pharmaceutical quality systems (PQS) must be able to collect, analyze, trend, and store data generated from process analytical applications (PAT).
The Way Forward
The pharma industry is facing monumental financial challenges but also extraordinary opportunities. These forces are combining to change the way the industry does business at its very core. An essential part of this revolution will be the transition from current manufacturing processes, technologies, and facilities to the facility of the future.
Timothy Tyson is chairman and CEO of Aptuit, Inc., which provides contract research, development, and manufacturing services. He has 30 years’ experience in the pharma industry, including top executive positions at Valeant Pharmaceuticals International, GlaxoSmithKline, Bristol-Myers, and Procter & Gamble. He is a member of various industry organizations such as ISPE (International Society for Pharmaceutical Engineering).