Lot Release Testing
Rapid lot release testing services for unprocessed bulk, purified bulk, and final product.
Supporting QA and QC departments by providing GMP compliant lot release testing programs designed to ensure the safety of your biopharmaceutical while keeping your timelines on track.
Lot Release Testing Overview:
- Over 30 years of product release experience – protein therapies, vaccines, cellular therapies, and viral vectors
- Global regulatory acceptance
- In-house analytical development design assays to meet specified validation parameters such as potency
- Accelerated tech transfer/comparability studies
- Dedicated Project Managers
- Lot Release Testing for every step of your bioproduction process
Lot Release Testing for every step of your bioproduction process
Unprocessed Bulk
- In vitro and in vivo virus screen
- Mycoplasma
- Sterility or microbial enumeration
- Quantitative Environmental Monitoring
- Product titer, identity, purity, and concentration
Sterility & Mycoplasma Testing
- Residual DNA
- DNA sizing
- Host cell protein
- Process residuals
- Sterility
- Pyrogenicity
- Endotoxin
- Identity, purity, and concentration
Final Product
- General safety
- Confirmation of potency, purity, stability, and efficacy
- Sterility
- Pyrogencity
- Endotoxin
For Lot Release of viral vectors, specific tests such as Replication Competent assays are required to address safety concerns caused by the potential outcome of recombination events.
AAV
- Interference and positive controls at two levels
- Cell-based assay for amplification, qPCR detection of DNA sequence
- Custom or semi-custom assay development capability
Lenti
- Culture or qPCR techniques
- Minimum of 5 passages on permissive cell line including positive, negative, and spike control
- Supernatant testing either 5% or 300 mL, whichever is less
- Vector producing or ex vivo transduced cell testing – 1% of total or 108 whichever is less