QC Release & Stability
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
