Aseptic fill finish (GMP)

Liquid drug filling capabilities: • Viral vectors • Monoclonal antibodies • Virus-like particles • Recombinant proteins • Diluent and placebo With aseptic filling operations in the U.S. and Europe, ABL provides the flexibility and logistical responsiveness needed to support global clinical trials. Meeting demanding timelines is what we do—whether a comprehensive GMP production program or a standalone drug product fill—we integrate vialing, inspection, labeling, testing, storage and distribution activities for the provision of clinical trial materials. ABL stands shoulder-to-shoulder with our clients as a catalyst for life-changing innovations. We’ve supported fill/finish projects for SARS-CoV-2 (COVID-19) vaccine candidates—and are available for new projects NOW. ABL has filled hundreds of GMP gene therapies, vaccines, oncolytic vectors and other immunotherapies at facilities located in the U.S. and Europe. Live virus fill/ finish in several standard vial configurations- with 100% visual inspection and ADQ procedures. • Primary packaging and labeling • Release testing and stability programs • On-site Quality Assurance oversight of all operations • Fast turnaround of phase material (as quickly as 1 week) • Commercial-ready facilities Standard fill capabilities: • Broad range of production scales: < 50 to thousands of vials per lot • 0.5 mL to 100 mL vial size accommodation • In-line weight checks on every vial (reported in the lot summary for every product fill) • QC inspection, GMP lot release and stability testing • Labeling, packaging and shipping • Standard materials include Type 1 borosilicate glass and Crystal Zenith® vials (in 2mL and 5mL size with rubber stoppers and tear off aluminum seals) • Line speed ranging from 9 vials per minute to 20 vials per minute, depending upon fill configuration • Ambient temperature fills • VHP room changeover post-fill