Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it is investing $50M to install an additional high-speed vial filling line at its Bloomington, Indiana, facility.
The new line is expected to be operational by April 2021 and will add capacity to support the growing pipeline of clinical programs and commercial launches at the site. It will provide sufficient capacity to produce up to 80 million vials annually under barrier isolator technology and a peristaltic pump filling mechanism, consistent with current good manufacturing practice (CGMP) regulations.
With its considerable experience in facility and capacity expansions, the Bloomington site has been able to accelerate the overall project from a typical 18-month timeframe to approximately 10 months in total, including construction, procurement, installation, and CGMP qualification of the new line.
“The industry has seen an increased demand for vial filling of biologic drugs, which has been compounded by the accelerated development of vaccine and therapeutic candidates to address the COVID-19 pandemic,” commented Mike Riley, Region President, Biologics, North America. “Catalent’s continued investment in this capacity will allow us to remain flexible and continue to support the growth of our customers’ programs.”
This marks the third major investment in the last two years at the Bloomington site. By the end of 2021, the site will have high-speed filling capacity across three vial lines, two syringe lines, and a flexible line capable of filling vials, syringes, or cartridges. The state-of-the-art facility has deep expertise in sterile formulation, with drug substance development and manufacturing and drug product fill-finish capacity, including primary and secondary packaging.
About Catalent Biologics
Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx® cell line development technology, and manufactured 35+ commercially approved products. Catalent Cell & Gene Therapy, a unit of Catalent Biologics, is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing. Catalent Cell & Gene Therapy has produced 100+ cGMP batches across 70+ clinical and commercial programs. For more information, visit biologics.catalent.com.
Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,900 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3B in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.