Our knowledgeable and dedicated team of scientists develop analytical test methods and qualification protocols to ensure the production of high-quality, and well-characterized material, in order to generate the data needed to support successful IND, IMPD and marketing applications.

Comprehensive Analytical capabilities:

• HPLC:
  -Size Exclusion, Reverse-Phase, Ion-Exchange, HILIC & HIC
• HPLC Titer
• ELISA & Cell-Based
• Enzyme Activity Assays
• Capillary Electrophoresis (CE-SDS & icIEF)
• SDS-PAGE & Western Blot
• SoloVPE & Other Protein Concentration Assays
• HIAC
• Compendial Assays
• High-Res Mass Spectrometry (LC/Q-TOF)
• In-Process Support & Release Testing
• Non-GMP Stability & Forced Degradation

The state-of-the-art, built-for-purpose, GMP manufacturing facility has the production capacity to scale your program from 50L to 2000 L. Using the same equipment families from bench processes, and leveraging single-use technologies, we can ensure an expedited path to the clinic.

Key manufacturing features:

• ISO Class 5, 7, and 8 controlled environments with BSL-2 certification
• Scale from 50L up to 2000L
• Licensed by the California FDB and registered with the US FDA since 2005
• Industry-leading Sartorius and Cytiva single-use technologies

QC analytical and microbiology laboratories are fully equipped to provide the comprehensive QC support needed to safeguard your program including release testing, Certificate of Analysis Generation, stability program management and raw material and in-process testing.

• Content (Concentration by SoloVPE)
• Purity (SE-HPLC, RP-HPLC, CE-SDS, icIEF, SDS-PAGE)
• Potency (ELISA, inc. Cell Based ELISA)
• Residual Impurities (HCP and Protein A ELISAs)
• USP & EP Compliant Compendial Methods
• Appearance, pH, Osmolality, endotoxin, bioburden

Our 22,000 sq ft GMP warehouse has 3 walk-in freezers and a continuous temperature monitoring system to ensure your product is appropriately stored.  Each package is inventoried using our electronic inventory management system, where raw materials are quarantined, released, and stored at their necessary requirements.

When it comes time to transfer your program to a downstream supply chain partner, our program managers work as an extension of your team to ensure on-time delivery, so that your project timelines and goals are always met.