The three-day event offered the opportunity to meet with exhibitors from every part of the pharma supply chain — from active ingredients to finished dosage formulations — as well attend educational sessions, see new technologies, and do a lot of walking.
The Pharma Manufacturing team was in attendance to find out what pharma’s top players had to say about the state of pharma and where the industry is headed next. Here are some key themes we gathered from briefings and meetings:
The continued rise of biologics
As pipeline and commercial biologic products continue to grow, the industry is facing an onslaught of new challenges. “When road conditions change, it’s time to check your roadmap,” said Peter Soelkner, managing director, Vetter Pharma. Many exhibitors at CPhI offered new solutions and approaches to optimizing the cost of biopharma development and manufacturing in order to help pharma companies remain competitive in this new landscape. Notable among these were a rising number of dedicated CMOs offering cell or gene therapy services.
The important roll CDMOs play in the industry
The new product pipeline continues to grow and new product approvals are at a record high. Additionally, as more therapies receive accelerated regulatory timelines, speed to market is imperative. All of this has created a huge need and opportunity in the contract manufacturing space. “CDMOs will have an increasing stake in providing solutions and being trusted partners to the industry,” said Peter Bigelow, president of xCell Strategic Consulting.
The continuous discussion continues
Despite strong endorsement by the FDA and years of discussion within the industry, few companies have made the switch from batch to continuous processing. Several factors, such as supply chain infrastructure, raw material characteristics, equipment costs and product volume, would need to be taken into consideration prior to making the leap to continuous. “If it was easy then continuous manufacturing — especially for formulations — would have been adopted in pharma manufacturing 60+ years ago,” said Girish Malhotra, president, EPCOT International, in the CPhI Annual Industry Report. The continuous discussion was alive and well at CPhI, with experts displaying a range of opinions during panel discussions, and exhibitors offering tools for those ready to make the switch. After the handful of early continuous adopters, the industry is seeing a second wave of implementation via CMOs, a bunch of which have begun converting facilities to offer continuous production services.
Strong emphasis on data integrity
Quality continues to be top of mind for pharma. As the amount of information generated by pharma manufacturing grows, so too has the emphasis by regulatory agencies on the accuracy and completeness of this data. In 2018, 57 percent of FDA warning letters were issued to pharma companies for failing to meet data integrity standards. Exhibitors at the CPhI took data integrity demands seriously, by offering better information management tools and systems, including alternatives to the commonly used spreadsheets and disparate IT systems.
