Biologics Manufacturing
FUJIFILM Biotechnologies - Holly Springs
Holly Springs, North Carolina
About FUJIFILM Biotechnologies - Holly Springs
FUJIFILM Biotechnologies operates a large-scale contract development and manufacturing organization (CDMO) site in Holly Springs, North Carolina. The facility is part of Fujifilm Corporation's global biologics network, which maintains additional production sites in the United States and Europe. The Holly Springs site houses eight 20,000-liter bioreactors for cGMP drug substance production, with co-located drug product capabilities that allow seamless transition from substance to finished dosage form. The company supports programs from pre-clinical development through commercialization, offering cell line and strain development, manufacturability assessments, cell banking, toxicology material generation, and IND/IMPD submission support. For clinical phases, it provides cGMP drug substance and drug product manufacturing, process optimization, scale-up, characterization, validation, and process performance qualification. Regulatory services include CMC support for BLA and MAA submissions. Recent press releases note a billion-dollar investment across the network and an accelerated expansion of the Holly Springs facility. The CDMO serves biopharmaceutical and biotechnology companies developing biologics, advanced therapies, and vaccines. Customers engage the site for projects ranging from early-stage cell line development to commercial-scale supply, with the company emphasizing end-to-end partnership across the product lifecycle. Fujifilm Biotechnologies differentiates itself through a "Partners for Life" philosophy built on three pillars: putting people first, transformative science and innovation, and unprecedented customer delivery. The Holly Springs site was selected for the FDA's PreCheck Pilot Program, aimed at advancing U.S. drug manufacturing resilience. The company also publishes an annual sustainability review aligned with its "Partners for the Planet 2030" ambition.
Manufacturing capabilities
Core processes
Inspection & quality
Industries served
- Biopharmaceutical
- Biotechnology
- Biologics
- Advanced Therapies
- Vaccines
Equipment
- 8 x 20,000 L bioreactors
Company details
- Location
- Holly Springs, North Carolina
- Certifications
- cGMP
Frequently asked questions
Where is FUJIFILM Biotechnologies - Holly Springs located?
FUJIFILM Biotechnologies - Holly Springs is located at Holly Springs, North Carolina.
What does FUJIFILM Biotechnologies - Holly Springs do?
FUJIFILM Biotechnologies - Holly Springs is listed under Biologics Manufacturing, and its listed capabilities and products include Biologics CDMO, Mammalian Cell Culture, Drug Substance Manufacturing, Drug Product Manufacturing, Cell Line Development and Strain Development.
What industries does FUJIFILM Biotechnologies - Holly Springs serve?
FUJIFILM Biotechnologies - Holly Springs lists Biopharmaceutical, Biotechnology, Biologics, Advanced Therapies and Vaccines among the industries it serves.
What certifications does FUJIFILM Biotechnologies - Holly Springs have?
Certifications on file for FUJIFILM Biotechnologies - Holly Springs: cGMP.
How do I request a quote from FUJIFILM Biotechnologies - Holly Springs?
Use the Request a quote button on this page to send FUJIFILM Biotechnologies - Holly Springs your requirements through FirmsLedger, or visit fujifilmbiotechnologies.fujifilm.com.
What companies are similar to FUJIFILM Biotechnologies - Holly Springs?
Other Biologics Manufacturing companies in North Carolina listed on FirmsLedger include KBI Biopharma - Durham, Amgen - Holly Springs and Grifols - Clayton.