INTERPHEX 2023, contract manufacturing, pharma manufacturing

While Contract Pharma & BioPharma manufacturers continue to experience an increase in demand for more projects, new challenges are emerging from nearly every angle including new regulatory and quality requirements, workforce shortages and of course, supply chain disruptions. At INTERPHEX 2023, QAD will share strategies leading Contract Development & Manufacturing Organizations (CDMOs) are implementing to keep customers happy while navigating these challenges. Here’s a quick preview of what you can expect during the panel discussion on Wednesday, April 25. 

Workforce Shortages

Contract manufacturers are taking a multi-faceted approach to manage workforce challenges. According to a new study by Deloitte and The Manufacturing Institute, the manufacturing skills gap in the U.S. is likely to reach 2.1 million and cost the economy $1 trillion in 2030 alone. And unfortunately, the situation is impacting CMOs as well and requiring leaders to be more creative and agile to attract and retain skilled workers. 

For example, rather than hiring someone with the required skill set, many companies are investing in training and development programs to upskill their workforce, and ensure that their employees are equipped with the skills needed to succeed in their role. They are also working to create a positive workplace culture that fosters engagement, collaboration, and innovation and include opportunities for team building, recognition programs and flexible work arrangements. In addition, contract manufacturers are using technology to automate tasks and streamline processes, reducing the need for manual labor and allowing workers to focus on more value-added activities.

New Regulatory & Quality Requirements

According to the Federal Register, the U.S. FDA has found that the majority of drug shortages stem from quality issues. “The discovery of substandard manufacturing facilities or processes, or identification of significant quality defects in finished products, necessitating remediation efforts, which in turn, may interrupt production, and cause a shortage of drugs.” In addition, the continued existence of product quality issues may point to increased complexities in the supply chain, limited innovation in manufacturing, inadequate adoption of modern manufacturing technologies and robust quality management systems. In an effort to address drug shortages, the FDA is proposing a voluntary phase of a quality metrics reporting program to learn more about a limited set of quality metrics and associated analytics.

How are manufacturers keeping up with demand while navigating workforce shortages and new regulatory and quality requirements? As part of evaluating current capacity needs, leading CMOs are implementing digitized workforce solutions, automating manufacturing processes, and streamlining quality control and continuous improvement initiatives. 

Capacity Expansion

To keep up with rising demand and the need for more specialized therapies, CMOs and  CDMOs like Catalent are investing in capacity expansion. This includes building new facilities, upgrading existing ones, and investing in new equipment and technology. In April 2022, its new CEO Alessandro Maselli announced an acquisition of Metrics Contracts Services for $475 million just one month into the job. This move was part of a series of acquisitions totaling more than $1 billion over the previous 12 months. The company like others has also been busy investing in the expansion of its current network of facilities.

Digital Manufacturing & Process Optimization

Contract manufacturers are constantly looking for ways to optimize their manufacturing processes to reduce costs and increase efficiency. This includes implementing new technologies, improving process automation and optimizing supply chain management. For example, implementing lean manufacturing and other best practices is helping leading CMOs reduce waste, optimize processes, increase efficiency and reduce lead times.

Investment in Quality

Contract manufacturers are investing in robust quality management systems and processes to ensure that their products meet strict regulatory requirements and customer expectations. This includes implementing quality control measures and investing in staff training and development. In addition, in an effort to support new regulatory and quality requirements as part of the FDA’s quality metrics reporting program, leading CMOs are leveraging integrated quality and manufacturing solutions to help ensure high-quality products and on-time delivery of important drugs and therapies.

Key Takeaways

At INTERPHEX 2023, join me alongside moderator Gil Roth, President, Pharma & Biopharma Outsourcing Association, and panelists, Robert Tufariello, Director of Finance, Epic Pharma, and Dan Matlis, President, Axendia, and learn the following:

  • Understand how CMO leaders are improving manufacturing throughput and navigating supply chain disruptions with alternative sources and suppliers, and better demand planning and forecasting
  • Learn how digital solutions are enabling better collaboration on the shop floor to improve workforce retention, productivity and efficiency
  • Walk away with new ideas on how you can improve manufacturing efficiency and supply chain operations and better prepare for future disruption

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