Analytical Testing & Release

We use a standardization approach for analytics offered to streamline upfront feasibility and shortening the distance to qualification. We utilize the flexibility to accommodate varying analytical methods and custom development as required.
Our stability support encompasses Developmental and packaging studies, stability protocol design, chromatographic analysis, wet chemistry and dissolution testing.
Close program oversight is in place from quoting phase through GMP Release of Materials by members of the QA team and close collaboration with the development aspects of the program to monitor Risk, Alignment with GMP manufacturing goals and IND submission needs for early-stage clients.
We deliver thoughtful, organized Documentation for GMP activities including Batch Records, Custom Analytical SOPs and Qualification Protocols/Reports, Raw Materials, and Raw Data.

Sanger Sequencing
NGS Sequencing Methods for ITR Constructs (outsourced to approved partner)
Residual Host Cell Protein (microBCA and ELISA)
Residual Host Cell DNA/RNA (std Gel Analysis, qPCR, and HPLC methods)
cIEF and cIEX methods
HPLC purity methods
LC/MS purity methods (outsourced to approved partner)
Mycoplasma by qPCR
Phage Testing and Organism ID
Full Analytical Method Development and Validation
Virtually any R&D technology platform can be supported through full GMP development, qualification/validation, and recurrent testing.

Integrated fully with cGxP Biorepository Functions/Services
Validated Stability Chambers with Temperature and Humidity Control
Multiple Standard Storage Modalities (Ambient, 2-8°C, -20°C, -80°C, LN2 -170°C)
Accelerated Degradation Studies
Full Customization including multiple conditions, sampling intervals, analytical tests

Biologics