New state-of-the-art cleanrooms will be the centerpiece of the already thriving small business, as the company seeks to expand their GMP-compliant manufacturing capabilities.
David Sheehan, CEO and Founder of Nucleus Biologics, ceremonially cuts the ribbon of the new GMP-Compliant manufacturing facility.
Nucleus Biologics’ newly expanded facility is officially open for business! A festive atmosphere marked the ribbon-cutting ceremony, which included presentations, food and beverages, and guided tours of the new clean room space.
Expansion of GMP services is central to Nucleus Biologics’ mission. The company is focused on providing premium quality cell culture products and services. That includes standard and custom media formulation, fully defined and validated cell culture media and supplements, and easily scaled order volumes and delivery. Additionally, Nucleus Biologics is working closely with its sister company, Stoic Bio, to incorporate more sustainable solutions into its products and services offerings.
When Nucleus Biologics was founded in 2016, their San Diego headquarters housed just a handful of employees. The company has now grown to 70 full-time employees, working at multiple manufacturing facilities nationwide, including the brand-new facility close by the original San Diego campus.
The new 20,000 square foot facility includes over 5,000 square feet of space housing four liquid media manufacturing cleanrooms, two powder cleanrooms, and four powder dispensing suites, all built to ISO 7 specifications for cell media manufacturing. One highlight of the cleanroom space is a large 2000L liquid media tank, capable of processing 2.5 million liters per year. This expanded capacity advances Nucleus Biologics goals of being the largest small lot custom media manufacturer on the market.
The expansion comes about one month after Nucleus Biologics attained ISO 13485:2016 certification for the manufacture and distribution of cell and gene therapy media. The expanded space will enable the company to fast track GMP-compliant materials for their customers, who will no longer have to queue up for dedicated facility time.
GMP-compliance, while not strictly necessary for cell and gene therapy process development, is necessary for human medicinal products to receive FDA approval. Early adoption of GMP-compliance gives companies working toward clinical approval of pipeline candidates a decided edge in the industry. GMP standards exist to ensure that all medicinal products intended for human use adhere to strict hygiene and quality oversight guidelines. As a result, GMP-compliant materials and methods provide documented transparency regarding purity, composition, and functional consistency. Strict protective measures are in place regarding contamination— whether for raw materials, manufacturing equipment, or product packaging, storage, and distribution systems.
The meticulous quality oversight of a GMP-compliant facility requires a greater dedication of resources for the manufacturer, but the benefits are substantial. The use of GMP materials means a much lower risk of failed or interrupted manufacturing runs that can happen when products do not pass performance or quality validation assays. Processes developed using research use only (RUO) materials must be requalified and revalidated with GMP-compliant materials in order to meet regulatory requirements for commercial scale-up and manufacturing. This a time-consuming, costly process that can significantly slow progress at a critical point in a company’s development. GMP-compliance, on the other hand, assures a streamlined, efficient process with built-in quality control. Equipment is extremely likely to be properly maintained and calibrated, processes are reliable and reproducible, and employees are well-qualified and fully trained.
The most important outcome, of course, is that early GMP-compliance benefits the patients waiting for much-needed medicines. Strict quality oversights significantly reduce the risk of product recalls or manufacturing and scale-up delays, with the result that medicines reach the patients who need them more quickly.
Nucleus Biologics new facility will greatly expand the company’s efficiency and manufacturing capacity, expediting the delivery of new cell and gene therapies to those who need them. Read more about the company’s innovative products and services here.
