QC Testing & Quality Assurance

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Quality Control : Release and Stability Analysis

Release

Quality Attribute

Method

Color, Clarity, Visible Particles -

Appearance

Total Protein Concentration -

Concentration by A280

pH -

pH

Safety -

Endotoxin, Subvisible Particles

Volume -

Extractable Volume

Potency -

Relative Potency ELISA

Purity -

Reduced CE, Non-Reduced CE, SEC-HPLC

Charge Profile and Identity -

CEX-HPLC

Impurities / Residuals -

Host Cell Protein ELISA, Protein A ELISA,Host Cell DNA PCR,Simethicone

Excipients -

PS80 HPLC-CAD

Stability

Appearance

Concentration by A280

PH

Subvisible Particles

Relative Potency

Reduced CE

Non-Reduced CE

SEC-HPLC

CEX-HPLC

PS80 HPLC-CAD

Dedicated QC Staff

Effective AD/QC method transfers and support

Qualified methods for Phase 1/2 GMP

QC Process

Quality Control

Release Testing

cGMP testing to ensure product quality, efficacy, & safety

Compliance with USP & EP compendia, client-specific methods

Qualified and calibrated instrumentation with robust data integrity systems

Comprehensive analytical testing of raw materials, in-process samples, finished product, and stability samples

Microbiological testing capabilities to support both DS and DP requirements

Stability Testing

Real-time and accelerated stability protocols with secure, monitored storage

ICH-compliant stability testing across all climatic zones

Forced degradation studies

Personnel Expertise

Experienced personnel with strong technical knowledge and operational efficiency

Experienced in supporting regulatory filings, and successful audits and inspections

Collaborative interaction with method development team ensuring transferrable and validateable methods

Quality Management System

Seamless Integration into Manufacturing

QMS is embedded into all operations, ensuring real-time quality oversight and compliance.

cGMP-Compliant Framework

Ensures adherence to global regulatory standards (FDA, EMA, ICH).

Phase-Appropriate Quality Oversight

Tailored quality controls from early development to clinical manufacturing.

Comprehensive Risk Management

Proactive identification and mitigation of quality risks.

Robust Documentation & Data Integrity

Ensures accurate record-keeping, traceability, and adherence to regulatory expectations.

Continuous Process Monitoring & Improvement

Data-driven strategies for enhanced product consistency.

Audit Readiness and Supplier Qualification

Prepared for client and agency inspections as well as the execution of supplier audits to ensure a compliant sustainable material and service support.