Comprehensive Quality Control Testing for Sterile Injectable Drug Products

Our analytical laboratory is equipped with a full range of testing services to deliver precise, reliable results for quality control (QC). As part of our seamless tech transfer process, our experienced lab team can acquire testing processes and customize them to your needs to ensure full regulatory compliance and product safety.

We provide chemical, biochemical, protein, microbiological, and physical property testing and can offer additional services based on your project’s needs as part of our Quality Management System (QMS).

To safeguard the quality of your APIs, raw materials, components, and other incoming goods used to manufacture your drug product, our team adheres to the following guidelines and procedures under a mature Pharmaceutical Quality System (PQS).

We protect laboratory operations with controlled access, continuous environmental monitoring, validated computerized systems, and comprehensive data integrity controls to ensure audit readiness and regulatory confidence.

• FDA 21 CFR Parts 210, 211, and 11
• EU GMP requirements, including Annex 1 – Manufacture of Sterile Medicinal Products
• ICH Guidelines (Q2, Q6, Q9, Q10)
• United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP)
• ISO regulations where applicable

Analytical Testing for Biologics

Our lab team offers the expertise and equipment to ensure the safety and quality of incoming materials for biologics manufacturing. When working with valuable APIs, we use methods to minimize API loss while ensuring the highest standards of purity and potency.

• Protein concentration (Lowry, BCA) for quantification
• SDS-PAGE, Western Blot, IEF for identity, purity, and molecular characterization
• ELISA for potency, binding activity, and immunogenicity screening
• Bioburden, Sterility, and Endotoxin testing
• HPLC/UPLC or biologics purity, size variants, and glycan profiling
• Karl Fischer for moisture content in lyophilized biologics
• Particulate analysis (USP <788>)
• FTIR to support identity testing and formulation characterization
• pH, osmolality, and conductivity
• TOC for cleaning validation and process water used in manufacturing
• Other testing methods as needed

Partnership and Technical Support

As your collaborative partner, our robust testing programs are designed to support your product release, stability, validation, and regulatory submissions. Our Quality Control organization operates as an integrated partner to manufacturing and quality assurance, providing timely data, strong scientific oversight, and clear documentation to support batch disposition, investigations, and regulatory inspections. From method transfer through commercial lifecycle support, our analytical laboratories are committed to reliable results, regulatory compliance, and continuous improvement.

Current Analytical Services Overview

Our Method Transfer & Validation team incorporates additional analytical services as part of our tech transfer process.