Our manufacturing development services help our clients think beyond current cell therapy manufacturing practices to develop approaches that address the core challenges presented by cell-based therapies.
We take a Development by Design (DbD) approach to manufacturing that takes into account a product’s quality, cost of goods, process scalability and sustainability, the critical drivers of successful commercial manufacturing, to help clients establish phase-appropriate manufacturing processes and plan ahead for eventual commercialization. We have also encountered first-hand—and analyzed case studies from—the industry’s experience with commercialization to date and determined that in order for cell therapies to be cost-effective, robust, scalable and sustainable, process innovation must be considered early on in the path from preclinical development to commercialization.
We provide process development and strategic manufacturing consultancy services for clients developing cell therapy products. We seek to develop scalable, sustainable, cost-effective and clinical phase-appropriate manufacturing processes for our clients’ cell therapy products, helping them to meet clinical enrollment timelines, costs, and milestones while maintaining high product and process quality standards.
Through this support, we allow our clients to submit the CMC documentation needed to establish their clinical manufacturing process and/or to leverage development plans created through our consultancy assessments to achieve funding and/or internal support.
Our offerings include the Strategic Manufacturing Assessment (SMA), Strategic Commercial Manufacturing Plan (SCMP) and customized manufacturing development services, including both process and analytical development.