GMP QC Testing Services

MoA‑reflective bioassay services aligned to your drug’s biology and mechanism

We Care About Your Compliance

GMP QC Testing Services

At Svar Life Science, compliance is built into how we work. Our QC team provides you with quality services from our GMP-certified facilities, in compliance with the latest regulatory requirements. We work closely with our QA and R&D experts to deliver high-quality GMP Bioassay service to support the release, stability, and in-process testing of your drug.

Integrated CMC bioassay services

Potency that reflects the mode of action (MoA) is central to regulatory expectations for biologics. We cover the full QC bioassay lifecycle from feasibility to long-term method monitoring with GMP lot release, stability, and in process testing at the core.

Why choose Svar for GMP QC Testing

GMP‑certified bioassay QC with scientific ownership

Direct access to the scientists running your assays, supported by integrated QA and R&D, delivering regulatory confidence, reliable release decisions, and patient safety.
MoA‑reflective potency assays built for QC reality

iLite® and custom cell‑based bioassays designed for robustness, transferability, and batch‑to‑batch consistency across release, stability, and in‑process testing.
Phase‑appropriate, end‑to‑end assay lifecycle support

Seamless progression from feasibility through development, qualification/validation, and commercial lifecycle monitoring—minimizing late‑phase surprises and accelerating timelines.
Embedded trending and lifecycle management for long‑term control

Proactive method trending, performance monitoring, and continuous improvement strategies ensuring sustained assay reliability from early development through commercial release.

Our QC Testing Services Offering

QC TESTING SERVICE

We perform early assessments of whether a potency or functional bioassay is fit for purpose, using limited‑plate feasibility to evaluate layout, curve behavior, signal‑to‑noise, variance, data‑transformation needs, and critical reagent performance. This allows to minimize downstream risk and to ensure the assay can be efficiently refined before full development.
QC TESTING SERVICE

We perform assay design and refinement to reflect the drug’s mechanism of action, optimizing plate setup, replicate strategy, parallelism/similarity assessment, specificity, and robustness. Early‑phase qualification demonstrates that the method is suitable and reliable for its intended context, establishing broad acceptance criteria aligned with the stage of development.
QC TESTING SERVICE

We carry out full GMP validation for late‑phase and commercial readiness according to ICH Q2(R2) (accuracy, precision, specificity, linearity, range, robustness), ICH Q14 (analytical procedure development and lifecycle control), and USP <1032–1034> (bioassay design and validation). This ensures your potency assay meets regulatory expectations for long‑term QC use in lot release and stability testing.
QC TESTING SERVICE

We perform routine GMP‑compliant relative potency testing for both drug substance and drug product using ligand‑binding assays (LBA) and cell‑based formats, ensuring the selected assay reflects your drug’s MoA. Release specifications are established together with your team to secure robust, phase‑appropriate batch release.
GMP QC TESTING SERVICES

We design and execute potency‑based stability studies under real‑time and accelerated conditions to evaluate product integrity over time. Stability studies are performed during all phases of drug development, including post-licensure studies, which are used to further monitor drug stability. Our GMP QC Services provide potency testing of stability samples to support both GMP and non-GMP stability studies. Additionally, we perform exploratory stability testing.
GMP QC TESTING SERVICES

We develop and apply rapid, purpose‑built bioassays to detect unexpected shifts during manufacturing, enabling timely in‑process control decisions. These assays are tailored for sensitivity to process variability and support both GMP and non‑GMP production environments.
GMP QC TESTING SERVICES

We execute risk‑based method transfers and ensure long‑term QC performance through continuous lifecycle monitoring — including control sample trending, SST criteria, curve‑fit parameters, and reagent qualification — to maintain method robustness throughout the assay’s lifetime.