Integrated Lab Testing Services
Xseer Pharmaceuticals operates a fully cGMP-compliant, FDA-registered analytical and microbiological testing laboratory. Engineered to support both our internal CDMO/503B manufacturing operations and serve as an independent contract testing partner, our laboratory delivers audit-ready data for pharmaceutical, biotech, and compounding facilities. We understand that laboratory delays are one of the most significant bottlenecks in product release. By combining advanced instrumentation with 21 CFR Part 11 compliant data management systems, we provide comprehensive, phase-appropriate testing with accelerated turnaround times—ensuring your product is supported by the analytical and microbiological data required for quality, regulatory, and release decisions.
Core Testing Capabilities:
- Analytical Chemistry
- Microbiological Testing
- Comprehensive Stability Programs
- Specialized CMC & Compendial Testing
- Regulatory & Validation Support
We utilize advanced chromatography and spectroscopy to deliver precise, stability-indicating assays and compendial testing for raw materials and finished products:
- Potency and Assay (HPLC, UPLC)
- Impurity Profiling and Residual Solvents (GC/UV)
- Water Content (Karl Fischer) and Total Organic Carbon (TOC)
- pH and Osmolality (USP <791>, <785>)
- Raw Material Identification (FTIR, UV-Vis)
- Stability-Indicating Method Development and Qualification
Our dedicated microbiology suite provides rigorous contamination control and sterility assurance data, leveraging both compendial and rapid methodologies:
- Compendial and Rapid Sterility Testing (USP <71>)
- Rapid microbiological testing supported by advanced technologies including BACT/ALERT®, SCANRDI®, and EndoSafe® systems
- Bacterial Endotoxin Testing (LAL, USP <85>)
- Bioburden Analysis (USP <61>) and Pathogen Detection (USP <62>)
- Antimicrobial Effectiveness Testing / AET (USP <51>)
- Environmental Monitoring and Water System Testing (USP <1231>)
We execute robust stability protocols within closely monitored environmental chambers to establish scientifically justified shelf-life assignments and beyond-use dates (BUDs):
- ICH Q1A-Compliant Long-Term and Accelerated Storage
- Dedicated Pull-Point Testing: Potency, Sterility, and Visual Inspection
- Freeze-Thaw and In-Use Stability Evaluations
We support the physical characterization and safety validation of your final dosage form and packaging components:
- Container Closure Integrity Testing (CCIT) utilizing validated deterministic and probabilistic methodologies, including dye ingress where applicable.
- Particulate Matter in Injections (USP <788>)
- Visual Inspection (USP <790>)
- Filter Integrity Testing and Gowning Qualification
- Phase-appropriate Method Development and Validation (Phase I–III, Commercial)
- Analytical Method Lifecycle Management
- Method Transfer and Verification
- CMC Data Assembly for IND/NDA/ANDA/BLA Submissions
Laboratory Testing Partners
- Emerging Biotech & Pharmaceutical Sponsors
- 503A Compounding Pharmacies & 503B Outsourcing Facilities
- Clinical Research Organizations (CROs)
- Medical Device & Combination Product Manufacturers
Typical Turnaround Times (TAT)
We recognize that time is a critical asset. Our laboratory is optimized to provide expedited testing options to support rapid batch release and urgent clinical supply needs.
| Test | Standard TAT | Rush Option |
|---|---|---|
| Sterility (USP <71>) | 14 days | 7 days |
| Bacterial Endotoxins (USP <85>) | 2–3 days | 24 hours |
| Stability Pull-Point Testing | 3–5 days | Priority Slot Allocation |
Why Choose Xseer Pharmaceuticals?
- All laboratory activities are conducted under the oversight of an independent Quality Unit and comprehensive QA review processes.
- FDA-registered and fully cGMP-compliant laboratory infrastructure.
- Robust data integrity controls supported by validated 21 CFR Part 11 compliant systems.
- Rapid microbiological methods for accelerated batch release.
- All results QA-reviewed and delivered as comprehensive, audit-ready Certificates of Analysis (CoAs).
- Seamless integration with your existing CMC and regulatory teams.
