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Manufacturing and Technology Development

Our manufacturing development and technology 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.

 

Manufacturing Development

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.

Technology Development

Through our technology development service offerings, PCT assesses new cell therapy manufacturing technologies and develops closed and automated manufacturing solutions for the cell therapy industry. Through these services, PCT intends to help clients move their cell therapy products into the cell therapy ‘factory of the future’, to ensure scalable, sustainable and consistent manufacture of cell therapy product.

Our technology development services are provided through PCT’s Center for Innovation and Engineering, where we assess clients and develop processes, technologies and automation, providing them with a robust strategy to lower the cost of goods and enable robust scale up of therapeutics.

Our Center for Innovation and Engineering develops partnerships with industry leaders in instrumentation to allow PCT early access to beneficial technologies and to engineer new solutions to advance the industry.

 

Beginning the Journey with a Development by Design Mindset