Improving Success for Cell Therapy with a Development by Design Methodology

PCT’s manufacturing development services help our clients think beyond their current-phase cell therapy manufacturing needs to create approaches to cell therapy development that improve the commercial viability of their products.

We take a Development by Design (DbD) approach to cell therapy manufacturing that takes into account the four key elements of a product’s commercial viability:

DbD

 

Quality.

The critical quality attributes (CQAs) that the product needs to meet at each clinical trial stage and in its final form.

Scalability.

The ability to manufacture doses on the scale necessary to meet demand while avoiding comparability risks.

Sustainability.

This includes factors such as the availability of raw materials and the availability of dedicated manufacturing facilities—and how to mitigate risks such as single-source supply or reimbursement challenges that can affect the long-term viability of a cell therapy product.

(COGs).

The high cost of goods for cell therapy products can be a limiting factor on their commercial viability. By minimizing the COGs for cell therapy manufacturing as processes mature, the sustainability and commercial viability of a cell therapy product can be improved.

These four factors are the critical drivers of successful commercial therapy manufacturing. We use the DbD philosophy to help clients establish a phase-appropriate manufacturing process that takes into account the eventual requirements of commercialization early on to smooth out the transition.

We also have first-hand experience with (and analyzed case studies of) the challenges various cell therapy developers in the industry have faced in commercializing their products. This experience is why we have determined that for cell therapies to be cost-effective, robust, scalable, and sustainable, then process innovation must be considered early on in the path from preclinical development to commercialization.

 

 

Providing Support for
Manufacturing Development

We provide both process development and strategic manufacturing consultancy services for clients developing cell therapy products. Through these supporting services, we seek to help clients develop scalable, sustainable, cost-effective, and high-quality clinical phase-appropriate manufacturing processes for their products. We help clients do this while meeting clinical enrollment timelines, cost goals, and other milestones in a process that maintains high quality standards from start to finish.

Through this support, we assist clients in submitting the CMC documentation needed to establish the clinical manufacturing process and/or leverage development plans created through our consultancy assessments to achieve funding and internal support.

Our consulting offerings include:

Customized Manufacturing Development Services.

Process Development

Uses numerous services to create a manufacturing process that is specific to the needs of your cell therapy development. Includes optimization of input materials and unit processes, closed processing and automation, and other improvements.

 

Analytical Development

We work with clients to create testing methods that satisfy the Chemistry Manufacturing and Controls requirements of an Investigational New Drug (IND) or Biologic License Applications (BLA) filing with the U.S. Food and Drug Administration. Analytical methods that we help clients develop: Identity, Purity, Potency, and Sterility testing—among other measures of safety.

Strategic Commercial Manufacturing Plans

Inform and align stakeholders so they can make informed choices regarding the needs for future development funding and project the COGs at both the commercial launch and at scale post-launch. An SCMP consists of three segments: evaluation, analysis, and recommendations.

Strategic Manufacturing Assessments

An SMA is a detailed analysis of your cell therapy process that defines the quality target for your product profile, the product’s critical quality attributes, the current state of unit operations, and suitability/gap analyses for technology transfers and clinical readiness.

Learn more about DbD:

Download the offer here