DEVELOPMENT

AUTOLOGOUS CELL THERAPY

Cell therapy is the prevention or treatment of human disease by the administration of a persons own cells that have been selected, multiplied and manipulated outside the body.

REGENERATVE MEDICINE

Engineering damaged tissues and organs by stimulating the body’s own repair mechanisms to functionally heal previously irreparable tissues or organs.

OUR APPROACH

Our dedicated team of cell therapy development scientists will assess your process and work with you to develop production methods to meet the requirements of your clinical programs. A product specific analytical testing program will be designed and assays qualified to ensure product quality is prioritized.

Our goal is to enhance your product development pipeline by providing expert advice and access to an integrated pipeline of services including:

  • Recommendations for process improvement and optimization
  • Qualification of appropriate analytical assays to evaluate safety, identity and purity
  • Protocol translation to a production method capable of GMP manufacture
  • Scale-up and automation assessments
  • Generation of test articles for pre-clinical and toxicology studies

We recognize that the development of robust and reproducible production methods becomes increasingly important as the product advances through clinical trials towards successful commercialization. Process development strategies can be implemented to gain efficiency while maintaining optimal safety and quality profiles. The identification of the key product attributes is summarized in the target product profile and considerations for process optimization are formulated to ensure success.

SCIENCE-DRIVEN

We have a range of approaches that can help tackle the challenges you might face in the development of cell and gene therapies. The clinical and commercial success of biotherapeutics hinges on the development of robust, reproducible and scalable processes. Prokidney’s extensive process development and analytical development capabilities help our partners generate active product at an attractive cost while enabling rapid, reliable transfer to cGMP manufacturing.

PROCESS DEVELOPMENT

Process development is a highly complex task, requiring custom-developed solutions for every cell product. Successful process development can, therefore, only be achieved through the application of extensive experience and expertise in all aspects of GMP manufacturing and quality control. The collective learning gained over a decade has provided us with a tremendous depth of process development and analytical knowledge, and the implementation of robust manufacturing solutions.