2024-06-20

Q: Kindly discuss ProPharma’s latest advancements in Clinical Research and what were the main goals of ProPharma in collaborating with PBL?

Being ProPharma, the first Research Consulting Organization (RCO), we have understood the importance of merging a traditional CRO with a consulting organization to holistically support advancements in Clinical trials. ClinCHAT is a good example of that. Through AI, ClinCHAT utilizes the latest natural language processing (NLP) and machine learning algorithms to provide a frictionless access to a database of some 340 million patients, 10 million physicians and over 420,000 clinical trials – to increase confidence and overall success in clinical research. In the collaboration with PBL ProPharma has seen an opportunity to contribute to the advancement in Cell&Gene Therapies (ATMP).

The CF Box is a tool which enables pharma organizations, hospitals and even research centers to advance their research and development of innovative medicine to address unmet medical needs. The CF Box is designed to provide functionalities that are not present in today’s market, which in conjunction with the access to ProPharma wealth of expertise is a unique recipe to overcome the challenges faced by those who aim at developing new C&G Therapies.

Q: How does the CF Box fit into ProPharma's overall strategy for CAGT manufacturing and what specific contributions did ProPharma make to the development of the CF Box?

ProPharma, with its CAGT Center of Excellence (CoE) is actively supporting CAGT manufacturers across the globe. The CAGT CoE is composed by several individuals with terrific expertise’s on CAGT and is led by one of the industry leaders in this area, Bob Beall. The CF Box is a product of that expertise and knowledge. Our experts have closely contributed to the design of the CF Box, pouring years of experience into the features of the machine which you see today. 

Q: What makes the CF Box a game-changer in the CAGT segment according to ProPharma and how does ProPharma support the implementation of the CF Box in various locations?

Flexibility is a key word here. The CF Box has been designed to automate manual processes and is therefore adaptable to perform various operations for most cellular cultures. The concept of automating manual operations facilitates the scale up from small manual batches to larger automated batches and is therefore the key to facilitating advancements in CAGT. Additionally, the CF Box allows the introduction and operation of various smaller equipment in the Box itself, preventing time consuming process changes.

Q: What challenges did ProPharma face during the CF Box development and how were they overcome?

Technically one of the biggest challenges has been coupling the automation aspects with the cell culture’s needs, as both retain inherent rigidities. Adding high GMP standards (both EU and FDA) has provided even further requirements. PBL and ProPharma have been successful in maintaining a high level of flexibility in the CF Box thanks to effective communication and mutual understanding of both the automation and cellular culture needs. The collaboration between the two organizations is shaped in mutual respect, which is what enabled the creation of the CF Box.