Our 87,000 square foot cGMP facility in Baltimore, MD, USA provides drug product manufacturing services for sterile injectables, specializing in aseptic fill/finish manufacturing, packaging, analytical services, and on-site testing and support services for clinical and commercial drug products.
This site has extensive experience in tech transfer, scale-up, and commercial production of both small molecules and biological compounds, and is capable of filling viscous and non-viscous solutions/suspensions.
Manufacturing
Bora’s Baltimore facility utilizes both modified RABs and state-of-the-art isolator technology, offering flexible and scalable fill/finish solutions for vials and pre-filled syringes in liquid and lyophilized formats.
With decades of experience in clinical and commercial production, our facility, experts, and capabilities can deliver a personalized manufacturing pathway to support our clients’ complex programs.
Compliance
We are committed to a regulatory compliant, robust quality system within our network and have been inspected and approved by the FDA & other global regulatory authorities.
Capabilities
- Clinical and commercial cGMP fill/finish manufacturing
- Vials & pre-filled syringes
- Liquid & lyophilization
- Inspection, packaging, and serialization
- Analytical services and on-site testing
