Sterile Injectables
Flexible and scalable fill/finish manufacturing solutions
As the demand for sterile injectable medicines grow, partnering with an experienced fill/finish manufacturer with the specialized capabilities, expertise, and capacity to safely and efficiently scale production is critical in strengthening your supply chain and delivering essential therapies to patients worldwide.
Bora’s 87,000 sq. ft. drug product manufacturing facility located in Baltimore, Maryland, USA, specializes in formulation, filling, inspection, packaging, labeling, and analytical services and on-site testing of liquid and lyophilized sterile injectable drug products. With extensive experience in clinical and commercial production, our experts in operations, manufacturing, analytical, quality, and regulatory are ready to support your specific cGMP program requirements.
Sterile Fill/Finish Manufacturing
Capabilities & Expertise
- Filling of vials & pre-filled syringes
- Extensive experience working with both small molecules and biological compounds
- Lyophilization capabilities: Three lyophilization units, including a small scale lyophilizer fully integrated with the groninger® FlexPro50 isolator filling line
- Terminal sterilization
- Clinical and commercial production
In-house inspection, packaging, and labeling solutions designed to fit your unique drug program needs
Visual Inspection: We perform visual inspection of vials and pre-filled syringes before they are released for clinical and commercial distribution.
Packaging and Labeling: Custom labeling and packaging solutions, including serialization and aggregation services and secondary packaging.
Comprehensive analytical services to help pave the way for your clinical and commercial program success
Our in-house analytical and microbiology labs provide method transfer and validation, in-process, final product, and stability testing services, and analytical support for developmental studies, ensuring rigorous quality control throughout your project’s lifecycle.
Making Success More Certain
As a future focussed CDMO, we know better than most that our own success is shaped by our partners victories. At Bora Pharmaceuticals, we see it as our mission, our duty, and our responsibility to make our mutual success more certain.