Drug Product Fill / Finish Services
ABL's aseptic filling operations in Rockville, MD, ABL provides the capability to support early clinical testing and the flexibility to accommodate your immediate needs.
Meeting demanding timelines is what we do—whether you need a comprehensive GMP production program or a standalone drug product fill. For DP, ABL integrates vialing, inspection, labeling, testing, storage and distribution activities for the provision of Ph I/II clinical trial materials
Expertise in fill and finish of high-value, low-volume viral products for clinical trials including gene therapy candidates, oncolytic vaccines, and immunotherapies.
Pre-qualified Vial Configurations
100% Visual Inspection and AQL Procedures
QC Release Testing
Stability Programs
Primary Packaging and Labeling
On-Site Quality Assurance Oversight
CDMO specializing in DP for viral therapies and vaccines
High Value, Low Volume
- DP fill/finish for live virus and other liquid products
- 2mL, 5mL and 10mL pre-qualified configurations
- Fill lots range from 200 up to 3000 vials
- Low hold up volumes
Multiple Configurations
- Automated Flexicon FPC50 filling machine
- Crystal Zenith® and Type 1 borosilicate glass vials
- Minimal line loss
- Clinical Phase I/II, BSL-2 support
Quality Control
- 100% visual inspection and AQL procedures
- Release testing and stability programs
- Primary packaging, labeling and shipping
- Industry-low reject rates
Liquid drug product filling capabilities
Oncolytics
Vaccines
Nanoparticles
Immunotherapies
Other Products
QC Release Testing Services
Safety
- Sterility *
- Mycoplasma *
- Bioburden Testing
- Endotoxin Testing
- Adventitious Agents *
Purity
- Western Blot Testing
- HPLC Testing *
- SDS PAGE
- Residuals Testing *
Potency
- Plaque Asssay Testing
- TCID50 Testing
- ELISA Testing
- Digital PCR Testing *
- qPCR Testing
Quality
- Total Protein
- Osmolality
- pH/Appearance
* outsourced service
ABL is the catalyst for your life-changing, innovative products.
Contact us at info@ablinc.com
