First published in Contract Pharma, March 10, 2022
Written by Kristin Brooks
With the pharmaceutical industry’s growing pipeline of biologics, products often delivered parenterally, and the impact of the COVID pandemic and vaccine production, the need for technically advanced manufacturing support has grown considerably and contract development and manufacturing organizations (CDMOs) are playing a vital role.
Throughout the pandemic, CDMOs of all sizes and capabilities stepped in to fulfill industry needs, providing the capabilities and capacities for the manufacture of essential medicines.
Jeff Clement, Executive Director, CDMO Business Development North America, PCI Pharma Services discusses the impact of the pandemic on CDMOs and parenteral market trends. –KB
: What are some of the key factors driving market trends in parenteral manufacturing?
: Currently, the greatest factor driving parenteral manufacturing is COVID-19. When the pandemic first caused shutdowns in March 2020, large CDMOs employed emergency products, such as vaccines, to address growing hospital needs and combat the rise of COVID-19 patients. Because of this, many pharmaceutical companies struggled to find production space and had to expand their outsourcing network, which reduced the overall global capacity for life-saving treatments. Small and mid-size CDMOs began taking on projects larger CDMOs previously handled, forcing the smaller organizations to implement new procedures and add new equipment. These CDMOs successfully emerged as key players in the pandemic pharmaceutical supply chain because they integrated new technology, remained flexible and maintained constant communication with their clients to meet their needs in a dynamic market.
: How are CDMOs and the industry adapting to the current manufacturing environment for parenterals?
: CDMOs, including PCI, expanded their capacities to manage the influx of business and ease the strain on the global supply chain. To offer these new capabilities, CDMOs must be united from top to bottom to account for every service. From the leadership team to engineering, to business development, all functional groups within an organization must be aligned to the company vision and be in constant communication. For example: the engineering group that operates in parallel with lyophilization development must be in lockstep with the business development team who secured the RFP , the operations team who will manage the equipment and the manufacturing personnel required to perform the drug product production. We learned that maintaining cohesion within the organization was crucial to our manufacturing processes – especially as we’ve continued to enhance our lyophilization capabilities – and will prove beneficial for long-term success.
: How are vaccine development and production needs impacting the industry?
: The development and production of COVID-19 vaccines have caused material shortages across the pharmaceutical supply chain industry. All CDMOs, regardless of size, use the same materials: tubing, connector, vessels, and filters. Given the need to mass-produce COVID-19 vaccines, smaller organizations have struggled to acquire these resources at a reasonable price. The high demand for these COVID-19 injectables caused some non-emergency-use vaccines to lose precedence, thus creating significant setbacks in administering them to patients. In addition, we had to stay on top of potential challenges with the supply chain, adjusted our forecasts, ordered extra supplies and leveraged existing relationships and partnerships to source materials as needed.
: What are the major challenges for parenteral drug product development and manufacturing?
: One of the biggest challenges CDMOs face is ensuring individual client needs are being met, especially as new products are being developed and manufactured. The most important aspect of this is guaranteeing the production of safe, quality therapies. Within the CDMO market, it’s crucial to have in-depth discussions with clients to understand their requirements and ensure we can help them reach their goals at the clinical stage while staying within budget. Keeping constant communication with clients during this phase is important because it provides insights into the drug development process and learnings that can be applied later at the commercialization stage.
: What are some key advances with respect to modernization of facilities and/or innovative approaches and processes for parenteral development/manufacturing?
: With the ongoing global capacity shortage, PCI is continuing to build on its current capabilities to assist existing and new clients in drug development and manufacturing. PCI added an additional large-scale lyophilizer to our Madison, Wisconsin location and is expanding its presence in New England with a supplementary high-throughput commercial facility in Bedford, New Hampshire. PCI also recently added a state-of-the-art robotic technology to two sites, San Diego and Melbourne, that can produce prefilled syringes and vials in a sterile environment, reducing room for human error. These additions will also increase the speed to market for clients, ensuring patients receive the drugs they need on time.
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