QC Release & Stability
We ensure that your products meet the most rigorous regulatory standards, through our expert team of scientists and comprehensive offering of quality control assays.
PRODUCT SAFETY & QUALITY
Rapid and reliable release across every batch
Quality Control batch release services are provided by our in-house team of quality control scientists, including quality personnel and an on-site qualified person (QP), ensuring that every batch has been produced in compliance with GMP guidelines and conforms to batch specifications. Stability storage and virus stability testing services are also offered in accordance with the International Conference on Harmonization (ICH) guidelines.
Our expert team provides consultative support service to accelerate your time to clinic or market, and assist you in designing a tailored quality control package to assess critical product quality attributes, product safety, and meet the expectations of global regulatory authorities.
QC Release & Stability Capabilities
- On-site QC laboratories
- Platform and ready-to-use assays
- Analytical Development services available
- Stability studies including accelerated conditions (ICH Q1A)
- Dedicated project manager to track release status
- Potency, titer, purity, identity, residual and safety assays
- Phase-specific qualification/validation (ICH Q2(R1)
- GMP Certificate of Analysis (CoA) with each batch
- On-site Qualified Person (QP) in EU
- QA-audited external contract laboratories
Looking for something different?
Vibalogics can assist you through a comprehensive service portfolio – ensuring success of your virotherapy, beginning with process development and technical transfer feasibility, through cGMP production and validation.
Virus Particle Analysis by MADLS Technology
Over the past two decades, we have seen continued advancement of virus characterization and quantification technologies come to market due to the progress made and demand from preclinical and clinical advancement of live viruses, vectored prophylactic vaccines, and gene therapy products to treat infectious diseases, cancer and various genetic disorders.