A biopharmaceutical company well-versed in small molecule manufacturing processes requested Greenleaf’s support in building out its cell and gene therapy (CGT) manufacturing facility processes. Specifically, Greenleaf was asked to assist in developing the company’s Quality Management System (QMS) for new modalities in order to understand its positioning for sustainability and expansion of operations.
Greenleaf experts conducted a review of the company’s QMS by identifying risks and opportunities for improvement in its existing practices across good clinical practices (GCP), good laboratory practices (GLP), and good manufacturing practices (GMP) activities. Greenleaf’s QMS review included an evaluation of existing standard operating procedures (SOPs) and quality manuals with an eye toward gaps where additional policies and procedures needed to be developed to ensure a successful expansion.
The final Greenleaf evaluation resulted in actionable recommendations for the company’s existing QMS. Coupled with Greenleaf’s strategic and ongoing support, the company was able to implement QMS improvements supporting new manufacturing practices for CGT products.